Development of a Robotic Ankle Assist Device to Improve Mobility in Individuals With Movement Disorders
Phase: PHASE1
Conditions: Cerebral Palsy
Sponsor: BiOMOTUM, Inc.

Chief Science O+icer 
 
NCT04516343 
 
6/10/2024 

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PROTOCOL TITLE:  Evaluation of the Safety and Efficacy of a Lower Extremity BiOMOTUM 
Exoskeleton in the Pediatric Population with Cerebral Palsy 
PRINCIPAL INVESTIGATOR:
Arun Jayaraman, PT, PhD
Department of Physical Medicine and Rehabilitation
Northwestern University
Shirley Ryan AbilityLab
355 E. Erie St. 
Chicago, IL 60611
Phone: (312) 238-6875
Fax: (312) 238-2081
ajayaraman@sralab.org
VERSION DATE:
06/01/2022
 
STUDY SUMMARY:
Investigational Agent(s) 
(Drugs or Devices)
BiOMOTUM RAAD/BiOMOTUM SPARK/other similarly 
updated BiOMOTUM model
IND / IDE / HDE # 
Indicate
Special Population(s)
Children 
 Children who are wards of the state 
 Adults Unable to Consent  
 Cognitively Impaired Adults 
 Neonates of Uncertain Viability 
 Pregnant Women 
 Prisoners (or other detained/paroled individuals) 
 Students/Employees 
Sample Size
30
Funding Source
National Institutes of Health (NIH)
Indicate the type of consent 
to be obtained
Written 
Verbal/Waiver of Documentation of Informed Consent
Waiver of HIPAA Authorization 
Waiver/Alteration of Consent Process  
Site
 Lead Site ( For A Multiple Site Research Study)
 Data Coordinating Center (DCC)
Research Related 
Radiation Exposure
Yes 
 No 
DSMB / DMC / IDMC
Yes 
No
OBJECTIVES:
Research Objectives
÷
Determine the effects of tri-weekly BiOMOTUM RAAD/BiOMOTUM SPARK/other similarly 
updated BiOMOTUM model resistance training on mobility-related and neuromuscular 
outcomes for two delivery modes:
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1.
Resistance training always under physical therapy (PT) supervision (optimal delivery 
mode)
2.
Resistance training with one PT-supervised session and two parent-supervised sessions 
per week to mimic how the resistance intervention would be realistically implemented 
during daily life.
÷
Evaluate the safety of the BiOMOTUM RAAD/BiOMOTUM SPARK/other similarly updated 
BiOMOTUM device in providing gait training intervention for persons with mobility 
impairments secondary to cerebral palsy through incidence of device related adverse events 
including serious adverse events and falls. 
÷
Explore the participant characteristics (e.g. age, gender, GMFCS level, walking speed, 
spasticity rating) that are associated with the greatest improvement in outcomes following 
each intervention.
BACKGROUND:
Clinical need 3 Children with cerebral palsy (CP) frequently experience a downward trend of 
reduced physical activity and worsening gait, leading to a permanent decline or loss in 
ambulatory ability (Fig. 1) [7]. For children with CP, walking is drastically more energetically 
expensive than for their typically developing peers [8]. Experts have called for new ways to 
elevate activity levels in children with movement disorders [2], [9]. The ankle joint plays a
critical role during walking, acting to stabilize, support, and propel the body [10]. Activation of 
the ankle plantar flexor muscles is reduced, less modulated, and often accompanied by co-
activation of the antagonist dorsiflexor muscles in a majority of individuals with spastic cerebral 
palsy (CP) [11]. Reduced ankle performance during walking in children with CP is suggested as
a primary contributor to the observed gait dysfunction [12]. Ankle plantar-flexors of children with 
CP produce 50% less positive joint work than in typical gait [1], resulting in a reliance on more 
proximally located muscles for forward progression [13]. These muscle activation characteristics 
likely contribute directly or indirectly to reduced energy exchange [14], elevated metabolic cost 
of transport [15], and lower levels of physical activity [16] in this patient population. Evidence 
suggests that addressing or augmenting the neuromuscular deficits at the ankle may allow 
children with CP to engage in greater amounts of habitual physical, which would likely have 
many additional physical and mental health benefits [17], [18].
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Preliminary Data
RAAD/SPARK Assistance 3 We have demonstrated improvements walking outcomes 
following treadmill and overground assistance-mode interventions. In our first treadmill study 
[3], [6], five participants with CP (ages between 5 and 30 years) practiced walking on an 
instrumented treadmill at self-selected speeds with powered plantar-flexion assistance. 
Participants exhibited a 19% reduction (p < 0.05) in net metabolic cost of transport (J kg-1 m-1) 
on average during treadmill walking with assistance compared to their normal (baseline) walkin 
condition. We also found that, compared to baseline, participants had reduced crouch by 14.4 ± 
4° (p < 0.05)
across the lower-extremity and increased in positive ankle power by 43.6 ± 7.4 % (p < 0.05), 
and decrease positive hip power, by 29.2 ± 6.0% (p < 0.01) All of these changes are 
biomechanically favorable.
Pilot over-ground training study: 6 individuals with CP (GMFCS I-III (I:3, II:1, III:2), ages 
between 7 and 31 years) completed four consecutive-day over-ground training sessions (89 ± 
16 minutes of assisted walking) and received pre- and post-training assessments [4]. Following 
training, walking speed increased 0.24 m/s (p = 0.006) and stride length increased 0.15 m (p = 
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0.002) during unassisted walking, while walking speed increased 0.28 m/s (p = 0.023) and 
stride length increased 0.17 m (p = 0.013) during RAAD-assisted walking. RAAD training 
improved stride-to-stride repeatability of soleus and vastus lateralis muscle activation by up to 
49%, while the amount of integrated stance-phase muscle activity was similar across visits and 
conditions. Relative to baseline, post-training walking with the exoskeleton resulted in a soleus 
activity pattern that was 39% more similar to the typical pattern from unimpaired individuals (p < 
0.001). In a head-to-head comparison to shod walking on the final visit, the optimized 
assistance level for each participant resulted in a 12.0 ± 4.0% (p=0.012) reduction in metabolic 
cost of transport. To the best of our knowledge, this is the first reported improvement in over-
ground walking efficiency for individuals with gait impairments.
RAAD/SPARK Resistance Precision Ankle Therapy Pilot Study (4-weeks, n = 6) 3 
Participants completed ten, 20-minute training sessions over the course of 4 weeks with 
progressively increasing levels of resistance. Precision resistance led to significantly improved 
(reduced) stance-phase ankle co-contraction (29 ± 13%, p = 0.04), a more normal plantar flexor 
muscle activation profile (30 ± 15%, p = 0.02). We also observed an increase in complexity of 
neural control of walking after training (5 ± 3%, p = 0.04), an improvement that was significantly
greater than those seen with age- and GMFCS-matched controls who had single event multi-
level surgery (SEMLS) or selective dorsal rhizotomies (SDR) (p < 0.01 for both). These 
improvements in neuromuscular control led to a more mechanically-efficient gait pattern (58 ± 
34%, p < 0.05), improved metabolic cost of transport (29 ± 15%, p < 0.05), and enhanced 
performance on tests of functional mobility (11 ± 9%, p = 0.04) and walking endurance (13 ± 
9%, p = 0.05). The rate at which wearable adaptive resistance re-training elicited improved
function was 3 3 6 times greater than what has been reported previously for gait training 
interventions [20], [21].
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STUDY ENDPOINTS:
Primary Endpoints
÷
Safety of the RAAD/SPARK for providing gait training interventions to address mobility 
impairments for children with cerebral palsy. This will be assessed by the number of 
device related adverse events including serious adverse events and falls throughout the 
duration of the study, including follow-up.
÷
Improvement in self-selected gait speed, as measured by the 10 Meter Walk Test 
without the device, following 12 sessions of training with the BiOMOTUM RAAD in 
resistance mode, as compared to baseline.
STUDY INTERVENTION(S) / INVESTIGATIONAL AGENT(S):
The RAAD/SPARK solution 3 The BiOMOTUM RAAD/SPARK is an intelligent, powered ankle 
device designed to increase independence, mobility, and deliver gait training to children with 
movement disorders, such as CP (details reported in [4], [6], [19]). Unique features of the RAAD 
include:
 Lightweight (<1.5kg, 70% resides around the waist) and grows with the child.
 <Assist-and-Go= 3 All-terrain mobility assistance (both stance and swing phase assistance [18])
 <Resist-to-Restore= 3 Precision ankle neuro-rehabilitation resistance therapy for long-term 
gains [5]
 Battery powered and cloud-connected 3 Tracks improvement and compliance; creates virtual 
community
 Simple, inexpensive, and fast to manufacture 3 Minimizes material and assembly costs
 Design that accommodates differences in anatomy (e.g. adjustable waist straps, cable lengths)
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 Streamlined operation 3 automatic calibration allows users to turn on device and start walking
All-terrain assistance control 3 We have developed a proportional joint-moment control 
strategy capable of reducing the energy cost of over-ground walking [4] and operating 
seamlessly across the variable walking conditions encountered during daily life. This closed-
loop approach utilizes embedded force sensors to provide intuitive, volitional control of 
exoskeleton assistance. As described above, this approach provides reliable, adaptive 
assistance by tracking demand placed on the biological joint. Two recent validation
studies ([19] and In Review) demonstrates the ability of our control system to appropriately
adjust RAAD assistance relative to the plantar-flexor muscle moment during accel/decel,
level, incline, and decline walking at slow, medium, and fast speeds; stair ascent and
descent; and 90° turning (87.7 ± 2.7% average accuracy, R = 0.96 ± 0.01 average correlation
coefficient). This closed-loop control system offers a practical way to augment real-world 
walking performance without the need for complex classification.
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Resist-to-Restore 3 We developed a purpose-built RAAD/SPARK resistance controller based 
on two primary design criteria. The first criterion was task-specificity: the controller must 
facilitate increased neuromuscular firing of the plantar flexor muscles during the portion of the 
gait cycle when they function to propel the body forward (i.e. push-off). The second criterion was 
user engagement: the controller should have minimal lag and provide a mechanical cue in 
response to changing user input (i.e. as someone pushes harder, more resistance is provided). 
To meet these goals, we implemented the inverse of our proportional joint-moment control 
scheme designed to provide adaptive resistance for a user to actively engage with during the 
stance phase of walking.
 
           
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First to market 3 There are no commercially-available wearable powered assistive devices 
available for children. We seek to provide the first such device available to purchase for families, 
clinics, and hospitals. We also aim to provide a cost-effective and affordable device for sale 
prior to gaining reimbursement coverage, which we expect to take several years.
Intelligent design 3 The RAAD/SPARK device was designed to maximize improvements in 
mobility. This is accomplished through the use of lightweight materials, like carbon fiber, and 
mechanical design. Unlike uncomfortable wearable <exosuits= that rely on the garment9s friction 
with the user9s bare skin, the RAAD/SPARK device ankle assembly is self-supported and the 
reaction forces from the Bowden cables are transmitted to the ground. Furthermore, the 
heaviest components, including the motors and battery, are located near the waist, which 
minimizes the metabolic energy required to carry the additional mass [22]. The cables, and 
uprights of the RAAD/SPARK
have built-in adjustability in order to adapt as a child grows. Each RAAD/SPARK device will 
come with the necessary components to grow with a child for an entire year. Following growth 
spurts, lightweight components, like the cables, carbon fiber footplates, and calf cuffs can be 
easily exchanged.
RAAD User Interface: The RAAD9s/SPARK9s physical user interface includes an on-off switch 
and a toggle switch for <Assist-&-Go= or <Resist-to-Restore.= The device needs to be initialized 
in
the phone app once per user by specifying their body mass, after which it can operate by the
physical switch. The system automatically calibrates the foot sensors for the first three steps
of walking, after which the torque gradually builds to the peak set point by 20% with each
consecutive step. The app allows control of the torque setpoint; default assistive and resistive
torque setpoints are 0.25 Nm/kg and 0.15 Nm/kg, respectively.
                                                        
   
All-Terrain Control: Our intuitive RAAD/SPARK control scheme (Proportional Joint-Moment 
Control) is based on the principle of providing assistance as a function of the biological ankle 
moment [19]. High resolution force sensors placed under the ball of the foot and the automatic 
calibration procedure are used predict the biological ankle moment. We have validated this 
control strategy in individuals with and without CP during treadmill, over-ground, stepping, 
turning, incline, and decline walking (see preliminary data). We have demonstrated that this 
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control strategy can effectively reduce the metabolic cost of transport during over-ground 
walking [4]. No adverse
events have occurred.
The BiOMOTUM RAAD/SPARK device will be stored in the Center for Bionic Medicine 
department, room 1402 in a locked area that is only accessible to trained research staff. 
It is determined that the study is not a significant risk with this device because of the safety
measures that will be employed while using the device. While using the BiOMOTUM 
RAAD/SPARK device, research participants will be supported at all times with trained research 
staff and, when needed, a gait belt or a harness per the discretion of the research staff. This 
safety precaution is commonly utilized in physical therapy practice with other robotic training 
interventions as well as traditional approaches like walking on compliant surfaces or balance 
beam walking. Thus, it is felt that the utilization of the BiOMOTUM RAAD/SPARK, with the 
safety measures described, does not pose a significant potential for harming research 
participants.
PROCEDURES INVOLVED:
1.
Screening/Baseline Procedures
1.1 We will recruit up to 30 participants meeting the inclusion criteria. Recruitment 
will occur through Shirley Ryan AbilityLab9s flagship hospital and all affiliate sites. 
We will also recruit form local physicians as well as the Cerebral Palsy Research 
Registry. Subjects will be divided into two groups: (a) always under therapist 
supervision and (b) with on therapist-supervised and two parent supervised 
sessions per week. Once subjects have agreed to participate in the study, they 
will be consented at the Shirley Ryan AbilityLab. Study staff will explain the 
study, a written consent form will be signed by the subject if 18 years or old (or 
by one parent/guardian if subject is under 18 years old). If subject is younger 
than 18 but older than 12, in addition to parental/guardian consent, the subject 
will provide verbal and written ascent to participate. Children younger than 12 will 
provide verbal ascent along with parental/guardian consent. A copy will be given 
to the subject while the original document will be kept in a secure, locked cabinet.
1.2 Following informed consent, subjects will undergo physical evaluation and 
screening exam by trained research personnel. Study staff must obtain medical 
clearance from all subjects9 physicians prior to baseline testing. 
1.3 Once they are enrolled, baseline outcome measures will be assessed by a 
trained research personnel.
2.
Procedures during Treatment
2.1 After the baseline testing is completed, subjects will begin 12 sessions of 
training, 3 sessions per week for 4 weeks (missing no more than 3 session9s 
total). Up to an additional 3 training visits and/or 2-3 weeks may occur should the 
BiOMOTUM RAAD/BiOMOTUM SPARK/other similarly updated BiOMOTUM 
device require maintenance or updates during the child9s participation. Additional 
visits should only be required if adjustment is needed to ensure safety following 
changes. 
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At minimum, 9 training visits can occur over 8 weeks. Training sessions will last 
up to 1 hour and will include walking training in the BiOMOTUM RAAD/SPARK 
device, with the device in resistance mode. Participants will be enrolled at 
GMFCS levels I-III, and randomly selected to complete the intervention in one of 
two modalities: (a) always under therapist supervision, and (b) with one therapist-
supervised and two parent supervised sessions per week. All sessions, including 
those that are parent-supervised, will take place at Shirley Ryan AbilityLab. 
During parent-supervised sessions that seek to replicate how a child would train 
at home, parents will ask their child to walk with resistance to the best of their 
ability until the time is up. Parents can use toys and snacks to incentivize session 
completion. 
Gait training will include approximately 20-30 minutes of treadmill walking; 
participants will complete three ~5-10-minute bouts of walking with seated rest 
periods in between. The research team will guide participants to walk at a 
moderate-to-high intensity for the duration of each walk as indicated by level 7 
(<Hard=) on the Pictorial Children9s Effort Rating Table (PCERT). To maintain 
intensity as participants progress through the protocol, the therapist will increase 
the treadmill speed and/or the resistance level once per week to ensure 
progression. Plantar-pressure biofeedback will be provided to each participant at 
least once per session.
2.2 For both delivery modes, the therapist will increase the resistance level once per 
week to ensure progression.
2.3 During training and assessment sessions, the BiOMOTUM RAAD/SPARK 
iPhone will record data from the device9s joint angle and Inertial measurement 
Unit (IMU) sensors regarding the subjects ankle angles and body position. 
Outcome Measures: 
The following outcome measures will be collected by trained research personnel for all subjects 
at the following testing points: baseline, 2-7 days post-intervention (after 12 training sessions), 
and 3 weeks following the final training session.
Clinical Performance Outcome Measures:
1.
10 Meter Walk Test (10MWT): The 10MWT assesses walking speed in 
meters per second over a short duration. Changes in gait speed that result in a 
transition to a higher category of ambulation classification resulted in better 
function and quality of life. In the 10MWT, subjects are directed to walk at their 
self-selected and maximum safe speed with effects of acceleration and 
deceleration minimized (by adding 1 meter at the beginning and at the end of the 
course to isolate the subject9s steady state speed). Any assistive device and 
orthotic should be kept consistent and documented. It should also be 
documented whether the gait is treated at <self-selected walking speed= or 
<fastest walking speed=. Three trials will be completed at the self-selected speed 
and three trials will be completed at the fast speed. If someone is unable to 
complete all trials, then the reason will be documented in the CRF. 
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2. 
6 Minute Walk Test (6MWT): The 6MWT measures the distance a 
subject can walkindoors on a flat, hard surface in a period of 6 minutes, using 
assistive devices, as necessary. Any assistive device and orthotic should be kept 
consistent and documented. The test is a reliable and valid evaluation of 
functional exercise capacity and is used as a sub-maximal test of aerobic 
capacity and endurance. This test will be performed while walking without the
device as well as with the BiOMOTUM RAAD/SPARK. It will be administered 
while wearing a mask to measure oxygen consumption (Cosmed K5B2 Metabolic 
Unit) when performed without the BiOMOTUM RAAD/SPARK. Electromyography 
may be used to assess lower-limb muscle activity during gait analysis trials 
and/or the 6MWT.
3. 
Timed Up and Go Test (TUG): The TUG assess mobility, balance, 
walking ability, and falls risk. The participant starts seated in a chair with his/her 
back against the chair back. On command, the participant rises form the chair, 
walks 3 meters, turns, walks back to the chair and sits down. Timing begins when 
the command to start is given and stops when the participant returns to a seated 
position. This test may be repeated up to 3 times during each assessment visit 
and during each training visit. 
4.
Gross Motor Function Measure -66 (GMFM-66): The GMFM-66 
measures change in gross motor function over time in children with cerebral 
palsy. This assessment quantifies motor function, not the quality of the motor 
performance. 
5.
Gait Analysis: A quantitative means of assessing gait function based on 
spatiotemporal parameters of gait. The GAITRite system is an electronic 
walkway with integrated sensors and is considered a reliable and valid means of 
assessing gait changes post stroke. Electromyography will be used to assess 
lower-limb muscle activity during gait analysis. This includes adding small 
sensors to thighs, lower legs, and shins. 
6.
Muscle Strength Testing: The purpose of this test is to evaluate the 
strength of the legs by having the subject perform isometric, maximum 
contraction while the researcher provides a static, counterforce. A handheld 
dynamometer will be used to detect the minimum muscle strength change.
Self-Reported Measures:
1.
Patient Questionnaires: This questionnaire will ask for the subject9s 
feedback regarding their experience and satisfaction after using the 
BiOMOTUM RAAD/SPARK device. 
On the first follow-up visit, we will assess subjective user experience 
and quantify the usability of the device. Each research PT, participant and 
parent/guardian will complete the System Usability Scale (SUS). The SUS 
includes 10 statements rated by means of a 5-point Likert scale, from 1 
(strongly disagree) to 5 (strongly agree), and the SUS scores have a range of 
0 to 100 that is divided by five scales: score of 0325: worst, score of 25339: 
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poor, score of 39352: OK, score of 52385: excellent, and score of 853100: 
best imaginable.
We will ask the participant to complete a custom, open-ended 
questionnaire with the following questions. Subjects have the right to refuse 
to answer to any questions they feel uncomfortable answering and the 
research team will mark these questions as unanswered.
(1)
Did you see a benefit of training with the device? 
a.
If yes, why? 
b.
If not, why? 
(2)
How did training with the device make you feel?
(3)
What were your favorite things about using the device? 
(4)
What were your least favorite things about using the 
device?
(5)
Is there anything that would make the device better to 
use? 
We will ask the parent/guardian to complete a custom, open-ended 
questionnaire with the following questions. Parents/guardians have the right 
to refuse to answer to any questions they feel uncomfortable answering and 
the research team will mark these questions as unanswered.
(1)
Do you think your child enjoyed using the device?
a.
If so, what aspects were enjoyable? 
(2)
How did you perceive how training with the device made 
your child feel?
(3)
Do you think there could be a benefit for your child to use 
such a device regularly during therapy? 
a.
If so, how? 
We will ask the lead research PT for each participant to complete a 
custom, open-ended questionnaire with the following questions:
(1)
Do you think the device was effective in improving the gait 
training activities for this participant?
a.
If so, how? 
b.
If not, why?
c.
Was there anything particular to this participant that 
influenced your response? 
(2)
Do you have any recommendations for how the device 
could have been more effective for this participant? 
2.
Visual Analog Scale: The 0-10 rating scale for pain is used to gain a 
subjective report of the intensity of a person9s pain. Zero represents <no pain= 
and ten represents <the most intense pain imaginable=. This will be in picture 
form using faces to depict the various levels of pain. 
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Wearable Sensors
1. 
ActiGraph activity monitors: These are devices with a small 
accelerometer that can be worn on a belt and/or on the ankle which can identify 
steps and kcals during daily activity. The Activity monitor9s battery lasts 2 weeks. 
Each subject will be given an activity monitor for 2 weeks prior to initiation of 
training, wear the monitor during each therapy session, and for up to 3 months 
following intervention. Subjects will be given instructions on how to maintain the 
device, including charging instructions.
2. Xsens: Xsens Awinda system (Xsens Technologies BV, Enschede, 
Netherlands) is used for real-time inertial motion capture during walking and 
dynamic activities. Motion capture data is collected from 17 IMU modules 
mounted on subject9s head, sternum, shoulders, upper and lower arms, hands, 
pelvis, upper and lower legs, and feet. Xsens9s proprietary software MVN 
Analyze 2019 captures the IMU data at 60 Hz sampling frequency. From the 
recordings, the MVN Analyze suite allows to exact kinematic from 23 different 
body segments. The system has been validated for realtime, reliable and 
accurate human motion analysis
3. EMG: Muscle activity will be collected from subjects by electrodes placed
upon the skin over specific muscles in the legs.
Video recording and/or pictures of each participant during assessments may be taken 
during the training and testing sessions. These items may be used to help troubleshoot 
potential issues. They may also be used for presentations and training of other research 
personnel. When feasible, attempts will be made to ensure the images or videos are 
devoid of any identifying information. Each subject may choose to limit if/how these 
items may be used, as indicated during their consent process. 
DATA MANAGEMENT AND CONFIDENTIALITY
Data will be collected and kept confidential and compliant with HIPPAA requirements. All
personal information and study documentation that can identify participants will be kept secure
to protect their privacy and will never be shared at any time with any person or entity. Data
collected during the study and shared with others will reference participants only by a  
deidentified alphanumeric code. The <master list= linking personal information to the 
alphanumeric code will not be shared and will be kept separately in a secured location. All data 
will be captured in electronic format and stored on the secure and password protected network 
and devices managed by the Shirley Ryan Ability Lab. Electronic folders will be private with 
limited access as determined by the PI.
De-identified data will be stored indefinitely. If participants give written consent to be contacted
for future studies, this information will be kept separate from de-identified data files, in locked
cabinets accessible only by authorized research personnel. All other information will be 
destroyed in accordance with HIPAA and IRB compliant guidelines.
SHARING RESULTS WITH PARTICIPANTS
There is no intent to share information with participants. However, if a participant or guardian 
requests information about the individual results, the results of their outcome measures will be 
shared verbally. No results of other study participants will be shared to maintain patient  
confidentiality. Once results have been published, subjects may request those results in so far 
as that such is open to the general public.
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STUDY TIMELINES
Study participation from initial consenting to post-intervention testing is anticipated to last up to 
7 months, but may be longer based on subject availability. We anticipate ongoing enrollment 
over 3 years. Investigators will complete this study (primary analyses) 4 years from IRB 
approval 
INCLUSION AND EXCLUSION CRITERIA
Inclusion Criteria:
1.
Diagnosis of cerebral palsy
2.
GMFCS level I 3 III
3.
Ability to walk for at least 6 minutes (assisted or unassisted)
4.
Age between 8-21 years
5.
Height/weight/BMI between the 5th - 95th percentile of children with CP
6.
Able to understand and follow simple directions
7. Able to safely fit into a device configuration and tolerate assistance without 
knee hyperextension while walking
8.
At least 20 degrees of passive ankle plantar flexion range of motion
Exclusion criteria: 
1.
Knee extension or ankle dorsiflexion contractures greater than 15 degrees
2.
Health condition or diagnosis other than CP that would affect safe participation
3.
Orthopedic surgery completed in the prior 12-months
4.
Current enrollment in a conflicting research study
VULNERABLE POPULATIONS
No greater than minimal risk to children is presented. Parent or authorized guardian will be
present during the consent process
PARTICIPANT POPULATION(S)
Accrual 
Number:
Category/Group:
(Adults/Children 
Special/Vulnerable 
Populations)
Consented:
Maximum Number to be 
Consented or 
Reviewed/Collected/Screened
Enrolled:
Number to Complete 
the Study or Needed 
to Address the 
Research Question
Children
100
30
Local
Children
100
30
Study-wide
Total:
100
30
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RECRUITMENT METHODS
Participants will be recruited through a rolling referral beginning immediately after the approval 
of this protocol. Recruitment will end once the appropriate number of subjects has been 
enrolled. To account for a subject withdrawal from the study, 2-3 extra subjects will be recruited 
in order to ensure there are enough subjects to confirm the results. Shirley Ryan AbilityLab 
physicians and clinicians will refer their patients based on their clinical presentation.
Trained research staff who have access to medical records will mine the data and identify all 
persons with cerebral palsy treated at the Shirley Ryan AbilityLab who may be eligible to 
participate in this study. A research team member will approach, call, or email the potential 
participants/participant9s legal guardian and introduce the study. If the patient/patient9s legal 
guardian is interested in hearing more about the study, the team member will describe the 
project in detail. The team member will have recruitment flyers and a copy of the consent 
available for review. Per the potential participant9s/participant9s legal guardian9s preference and 
continued availability, consenting procedures may occur at this time or a later time. If the 
patient/patient9s legal guardian agrees to participate in the study, the team member will obtain 
written documentation of informed consent. 
Shirley Ryan AbilityLab approved flyers will be hung at the facility to advertise the study. 
Clinicians at this location will be informed of the inclusion and exclusion criteria for this study in 
order to refer appropriate subjects. Information regarding this study will be posted on Shirley 
Ryan AbilityLab9s available research studies webpage. Research Registries at Northwestern 
University and affiliates may also be utilized to find eligible participants. Potential research 
subjects will be referred to, and evaluated by, authorized research personnel. Potential research 
subjects will be identified based on inclusion and exclusion criteria. After identification of 
subjects based on inclusion and exclusion criteria, a verbal permission from the patient or 
authorized guardian will be obtained to request medical clearance from their physician. 
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES
Subjects will be seen for 12 training visits, with additional visits for screening, baseline and post-
training evaluations, as well as up to 3 additional visits as needed. Each visit will last up to 4 
hours. Subjects will be paid $50 per session for their study related visits and travel mileage to 
and from the Shirley Ryan AbilityLab. Compensation will be paid by Clincard from Shirley Ryan 
AbilityLab.  Payments in excess of $600 in a calendar year are required to be reported as 
taxable income.
WITHDRAWAL OF PARTICIPANTS
Subjects will be withdrawn from the study in the event of a medical event or complication (i.e. 
hospitalization) that may alter the inclusion/exclusion criteria or which limits the patient from 
safely completing the remainder of the study, or at the discretion of the PI. 
 
Subjects can voluntarily discontinue the study at any time. The participant will then be requested 
to notify the Principal Investigator, Dr. Arun Jayaraman, in writing or call at 312-238-6875, if 
assistance is needed in this process. Information collected prior to the study discontinuation by 
a participant may still be used by the research team.  
The researchers reserve the right to discontinue study participation for any individual or for the 
study as a whole at their discretion.
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RISKS TO PARTICIPANTS
All testing and training sessions will be under supervision of a trained researcher.  Manual 
assistance or cueing will be provided as necessary for safety and balance.  Vital signs will be 
monitored before and after physical exertion and during activities, as needed.  All subjects will 
be permitted to stop physical activity or rest at any time during the study. 
÷
The risk of falling: This could be caused by loss of control of ambulation by the 
participant or therapist as well as malfunction of the BiOMOTUM RAAD/SPARK device 
itself. The risk of falling will be minimized by having experienced SRALAB research 
personnel conduct the participant training sessions with manual assistance, and as 
needed overhead attachment with a safety harness and/or gait belt during over-ground 
gait training. 
÷
Discomfort, skin pressure/friction, bruising, pain, or unusual swelling caused by the 
exoskeleton which has the potential to lead to skin breakdown or abrasions. This risk will 
be minimized by a thorough skin check performed by experienced research personnel at 
each training session. Adjustments to the device fit and additional padding will be 
assessed to decrease the risk of skin breakdown as well. 
÷
There may also be a risk of skin irritation caused by the adhesives used to secure the 
sensors, EMG sensors, and IMUs to the participant. This will be reduced by careful 
monitoring of skin when these devices are utilized.
÷
Blood pressure instability during use of the device related to standing and walking 
activities during testing and training procedures. This risk will be reduced with frequent 
subjective assessment of patient9s symptoms as well as assessment of blood pressure 
and heart rate prior to training, as necessary during training and following training. 
Activity will be stopped in the event of instability of vital signs and as recognized by 
experienced research personnel. Medical clearance will be required prior to any study 
related activities.
÷
Risk of exceeding range of motion: This would be caused if any device moves the 
Participant beyond the normal range of motion, resulting in a strain, sprain or fracture. 
For the BiOMOTUM RAAD/SPARK device, this risk is lessened by mechanical hard 
stops that prevent the device from exceeding a normal human range of motion even in 
the event of an electrical or software failure. Software systems are also in place to 
further reduce range of motion to improve fit and comfort during walking. Participants will 
be evaluated by clinicians who will eliminate Participants from being included in the 
study if Participants cannot meet the required range of motion. For all other devices, this 
risk will be mitigated through proper settings by the physical therapist in charge of 
Participants treatment.
÷
Spasms triggered by joint movement in the device. This risk will be reduced through 
screening prior to enrollment in the study. Participants cannot take part if the 
participant9s muscles are too stiff.
÷
There is a risk of fractures when participating in a therapy program: this will be 
minimized by requiring medical clearance if participants are at risk for severe 
osteoporosis.
÷
The device itself could malfunction. All activities will be performed with close supervision 
from trained research personnel to monitor device function during use.
÷
The use of the BiOMOTUM RAAD/SPARK system may involve risks that are currently 
unforeseeable as this is a trial to assess use of the BiOMOTUM RAAD/SPARK device in 
the pediatric population with cerebral palsy.
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POTENTIAL BENEFITS TO PARTICIPANTS There may be no direct benefit to the 
participants. The main benefit of this study is to better understand the use of technology to 
enhance gait ability of pediatric population with cerebral palsy. 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF 
PARTICIPANTS
Participants will be notified if any new information concerning the safety of the study device 
becomes available which may affect their decision to remain in the study. Participants will 
however be asked to perform all activities under the supervision of a trained research staff 
member.
DATA SAFETY AND MONITORING PLAN
The risks in this study are minimized by the use of extensive inclusion criteria and by close 
monitoring of the research subjects by experienced physical therapists. In addition, the primary 
research team is qualified and experienced in all of the study procedures. Nonetheless, since this 
study places the subjects at more than minimal risk, we utilize the services of a volunteer to serve 
as a Safety Officer at each sub-award research site. 
1.
Safety Officer(s) 
1.
The Safety Officer at each research site will be solicited upon receipt of award and 
will be a faculty member from each sub-award location (NAU, Gillette, SRA Lab) 
who is experienced in clinical research. We will avoid conflict of interest by 
recruiting a person who is not affiliated with any member of the research team (i.e. 
not a collaborator) 
2.
The Safety Officer will meet with study investigators twice annually. During these 
meetings, the following information will be reviewed: 
i.
Adverse events report (see below) 
ii.
Recruitment and enrollment statistics including the following information: 
1.
Gender, ethnicity 
2.
Number of subjects who were disqualified prior to randomization 
and reasons 
3.
Number of subjects randomized 
4.
Number of subjects who have withdrawn or been withdrawn from 
the study, and the reasons for withdrawal 
5.
Number who subjects who have completed each phase of the study 
3.
The Safety Officer will take minutes of the meeting, and after the meeting will 
distribute copies of the minutes to each of the investigators. The minutes will be 
reviewed at the beginning of the next Safety Officer meeting 
2.
Adverse events reporting 
The sub-award lead investigator (Dr. Lerner, Dr. Schwartz, and Dr. Jayaraman) will 
continually monitor all adverse events during the screening process and during 
procedures performed as part of this research. 
i.
When a screening failure occurs, the individual will be contacted by the sub-award 
lead investigator and be informed of the reasons for screening failure. 
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ii.
All adverse events will be reported to the safety officer monthly, and documented 
by standard IRB procedures and will be reported during the annual protocol review. 
Adverse events will be any event that does not satisfy the criteria for serious 
adverse events.
iii.
All serious adverse events will be reported immediately to the safety officer, IRB 
Research Subjects Advocate, and the NIH, in a timely manner (e.g. within 48 h) 
using the IRB Serious Adverse Report Event (SAE) form. The PI will sign each 
SAE, and a copy of the consent form signed by the subject will be included, with 
relevant sections highlighted. Serious adverse events are defined as:
1.
Death 
2.
Life threatening injuries 
3.
Inpatient hospitalization 
4.
Persistent or significant disability/incapacity 
5.
Congenital anomaly/birth defect. 
For all serious adverse events that are determined by IRB to be definitely, probably, or 
possibly related to the study or interventions, the IRB will take whatever action(s) it deems 
appropriate, including but not limited to: 
1.
Modification of the protocol 
2.
Modification of the consent form document 
3.
Modification to the timetable for continuing review requirements 
4.
Suspension of new enrollment into the study 
5.
Suspension or termination of the study - If the study is suspended or terminated, it 
will be promptly reported to the NIH institute that has provided funding for the study. 
All other events not requiring suspension or termination shall be reported during 
the annual progress report. 
ClinicalTrials.gov Requirements
This study will be registered on ClinicalTrials.gov. All relevant findings will be reported at the end 
of the study.
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS
Every possible precaution will be taken to protect the privacy interests of subjects. Participation 
in this study is completely voluntary. Trained research personnel will explain the purpose of the 
study and intended use of subject9s personal health information and precautions taken to keep 
the study information and data confidential.
Subjects have the right to refuse to answer to any questions they feel uncomfortable answering
and the research team will mark these questions as unanswered. Furthermore, participants can
refuse other objective tests in the protocol however if the participants refuse the majority of tests
which affect the overall implementation of the study, the participants may be withdrawn from the 
study at the discretion of the principal investigator. 
COMPENSATION FOR RESEARCH-RELATED INJURY
If the participant has any injury or illness from the study device or the procedures required for 
this study, the reasonable medical expenses required to treat such injury or illness may be paid 
for by the study sponsor.
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The coverage for such injury or illness is only available if the Northwestern University principal 
investigator and study sponsor have decided that the injury/illness is directly related to the study 
device or procedures and is not the results of a pre-existing condition or the normal progression 
of the participant9s disease, or because they have not followed the directions of the study 
doctor. If the participant9s insurance is billed, they may be required to pay deductibles and 
copayments that apply. The participant should check with their insurance company about any 
such payments.
ECONOMIC BURDEN TO PARTICIPANTS
Costs associated with participation in the study will be offset by payment for each in person
session ($50 each training session and $50 for each assessment).
CONSENT PROCESS
It is expected that the IRB will have the proper representation and function in accordance with
federally mandated regulations. The IRB should approve the consent form and protocol. In 
obtaining and documenting informed consent, the investigator should comply with the applicable 
regulatory requirement(s), and should adhere to Good Clinical Practice (GCP) and to ethical 
principles that have their origin in the Declaration of Helsinki.
Before recruitment and enrollment onto this study, the patient will be given a full explanation of 
the study and will be given the opportunity to review the consent form. Each consent form must 
include all the relevant elements currently required by the FDA Regulations and local or state 
regulations. Once this essential information has been provided to the patient and the 
investigator is assured that the patient understands the implications of participating in the study, 
the patient will be asked to give consent to participate in the study by signing an IRB approved 
consent form.
Should there be amendment made to the consent form after the initial signature of the original, 
the subject will be required to sign a new consent form at their next visit. A researcher will 
review the changes and discuss the implications of the change.
Prior to a patient9s participation in the trial, the written informed consent form must be signed 
and personally dated by the patient and by the person who conducted the informed consent 
discussion. The consent process will take place at the Shirley Ryan AbilityLab in Room 11- 
1402. Trained research personnel will guide the subject through consenting process. Subject 
will be given detailed explanation of the purpose, time line, commitment, procedures, data 
handling and privacy and confidentiality of information pertaining to the study.
NON-ENGLISH SPEAKING PARTICIPANTS
An interpreter who speaks the participant9s primary language will be scheduled through the
Shirley Ryan Ability Lab Interpreter Services department to attend all research appointments
during which the participant is scheduled if necessary as determined by the participant.
PARTICIPANTS WHO ARE NOT YET ADULTS (infants, children, teenagers)
Participants will be asked their age upon study screen. Any child under the age of 18 years will 
be considered a minor. If the participant is determined a minor, every effort will be made to 
ensure the screening process proceeds with a parent or an authorized legal guardian present. 
The consent and protocol will be explained by a trained researcher to both the present 
parent/authorized legal guardian and the minor. The parent or authorized legal guardian will 
then be asked to consent on behalf of the minor, in accordance with the DHHS and the 
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USFDA9s subpart D. The parent or authorized legal guardian will also be given the opportunity 
present at all training and testing sessions. 
Consent will be obtained from one parent even if the other parent is alive, known, competent, 
reasonably available, and shares legal responsibility for the care and custody of the child. This 
will be done to ensure the protocol is carried through in a timely manner.
Permission will also be obtained from an authorized legal guardian if necessary. Efforts will be 
made to determine whether the guardian is in fact legally authorized by ensuring the child lives 
with the aforementioned guardian. 
Assent will be obtained from all children. Verbal assent will be obtained for children unable to 
give written consent. Assent will be documented in the IRB approved consent form.
PROTECTED HEALTH INFORMATION (PHI AND HIPAA)
Subjects records will be kept completely confidential: Every possible precaution will be taken to 
protect the privacy interests of subjects. Participation in this study is completely voluntary. 
Trained research personnel will explain the purpose of the study and intended use of a subject9s 
medical information and the precautions taken to keep the study information and data 
confidential. Data will be collected and kept confidential and compliant with HIPAA standards.
Participants will be assigned an alphabetical or numerical study ID. Identifying data will be kept 
in locked cabinets and password protected servers completely separate from de-identified data. 
Research data will be de-identified and stored in locked cabinets in the lab accessible only by 
authorized research personnel. Electronic data will be de-identified and kept on secure, 
password protected servers at the Shirley Ryan Ability Lab. Only authorized research staff will 
be able to access any of the formerly mentioned data. De-identified data will be kept indefinitely. 
Study documentation will be collected and stored and kept confidential and compliant with 
HIPAA requirements. Identifying data will be held for 7 years after the study is completed and 
published.
All personal information (names, addresses, email or phone numbers, etc.) gathered for this 
study that can identify participants will be kept secure to protect their privacy and will never be 
shared at any time with any person or entity. Data collected during the study and shared with 
others will reference participants only by an alphanumeric code. The <master list= linking 
personal information to the alphanumeric code will not be shared, and will be kept by the study 
PI in a secure location. All personal information linking participants to their data will be 
destroyed after 7 years following the completion of the study.
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE
The Shirley Ryan AbilityLab services the cerebral palsy population and is a research hospital 
that maintains a research registry (greater than 750 participants). In addition to our flagship 
hospital, we have outpatient clinics that provide long-term follow-up care to this population. We 
will recruit participants from our research registry, website and outpatient affiliates and facilities 
to meet our enrollment goal.
All study team members will be trained on the study protocol and procedures. Experienced
physical therapists will lead the assessment and treatment sessions. The study team members
are employees of the Shirley Ryan AbilityLab. They are familiar with the study site and are
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experienced with the study population. There will be medical resources including a resident on
call and nursing staff available 24 hours a day if needed in case of an emergency. All our
treadmills have overhead harnesses for additional safety during training.
The principal investigator of this study, Arun Jayaraman, PT, PhD, is Director of the Max Nader 
Center for Rehabilitation Technologies and Outcomes (RT&O Lab), within CBM. Adequate 
dedicated office and treatment space is available for private meetings with potential subjects, 
performing physical evaluations, explaining the study protocol and obtaining study consent, 
performing data analysis, and writing manuscripts.
REFERENCES
[1] 
S. J. Olney, H. E. MacPhail, D. M. Hedden, and W. F. Boyce, <Work and power in 
hemiplegic cerebral palsy gait,= Phys. Ther., vol. 70, no. 7, pp. 4313438, 1990
[2]
 D. L. Damiano, <Activity, activity, activity: Rethinking our physical therapy approach to 
cerebral palsy,= Phys. Ther., vol. 86, no. 11, pp. 153431540, 2006.
[3] 
Z. F. Lerner, T. A. Harvey, and J. L. Lawson, <A Battery-Powered Ankle Exoskeleton 
Improves Gait Mechanics in a Feasibility Study of Individuals with Cerebral Palsy,= Ann. 
Biomed. Eng., vol. 47, no. 6, pp. 134531356, 2019. 
[4] 
G. Orekhov, Y. Fang, J. Luque, and Z. F. Lerner, <Ankle Exoskeleton Assistance Can 
Improve OverGround W
[5] 
B. C. Conner, J. Luque, and Z. F. Lerner, <Adaptive Ankle Resistance from a Wearable 
Robotic Device to Improve Muscle Recruitment in Cerebral Palsy,= Ann. Biomed. Eng., 
2020.
[6] 
Z. F. Lerner et al., <An untethered ankle exoskeleton improves walking economy in a 
pilot study of individuals with cerebral palsy,= IEEE Trans. Neural Syst. Rehabil. Eng., 
vol. 26, no. 10, pp. 198531993, 2018. 
[7] 
K. F. Bjornson, B. Belza, D. Kartin, R. Logsdon, and J. F. McLaughlin, <Ambulatory 
physical activity performance in youth with cerebral palsy and youth who are developing 
typically,= Phys Ther, vol. 87, no. 3, pp. 2483257, 2007. 
[8] 
J. Rose, J. G. Gamble, A. Burgos, J. Medeiros, and W. L. Haskell, <Energy Expenditure 
Index of Walking for Normal Children and for Children With Cerebral Palsy,= Dev. Med. 
Child Neurol., vol. 32, no. 4, pp. 3333340, 1990. 
[9] 
M. L. Aisen et al., <Cerebral palsy: clinical care and neurological rehabilitation,= Lancet 
Neurol, vol. 10, no. 9, pp. 8443852, 2011. 
[10]
D. A. Winter, Biomechanics and motor control of human gait: normal, elderly and 
pathological. 1991. 
[11] 
V. Dietz and W. Berger, <Cerebral Palsy and Muscle Transformation,= Dev. Med. Child 
Neurol., vol. 37, no. 2, pp. 1803184, Nov. 2008. 
[12] 
T. F. Winters Jr, J. R. Gage, and R. Hicks, <Gait patterns in spastic hemiplegia in 
children and young adults,= J. Bone Jt. Surg. - Ser. A, vol. 69, no. 3, pp. 4373441, 1987. 
[13] 
K. M. Steele, A. Seth, J. L. Hicks, M. S. Schwartz, and S. L. Delp, <Muscle contributions 
to support and progression during single-limb stance in crouch gait,= J. Biomech., vol. 
43, no. 11, pp. 209932105, 2010. 
[14] 
B. C. Bennett, M. F. Abel, A. Wolovick, T. Franklin, P. E. Allaire, and D. C. Kerrigan, 
<Center of Mass Movement and Energy Transfer During Walking in Children With 
Cerebral Palsy,= Arch. Phys. Med. Rehabil., vol. 86, no. 11, pp. 218932194, Nov. 2005. 
[15] 
V. B. Unnithan, J. J. Dowling, G. Frost, and O. Bar-Or, <Role of cocontraction in the O2 
cost of walking in children with cerebral palsy.,= Med. Sci. Sports Exerc., vol. 28, no. 12, 
pp. 14983504, Dec. 1996. 
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[16] 
D. L. Johnson, F. Miller, P. Subramanian, and C. M. Modlesky, <Adipose tissue 
infiltration of skeletal muscle in children with cerebral palsy.,= J. Pediatr., vol. 154, no. 5, 
pp. 715320, May 2009. 
[17] 
I. Janssen and A. G. LeBlanc, <Systematic review of the health benefits of physical 
activity and fitness in school-aged children and youth,= Int. J. Behav. Nutr. Phys. Act., 
vol. 7, no. 1, p. 40, 2010. 
[18] 
F. J. Penedo and J. R. Dahn, <Exercise and well-being: a review of mental and physical 
health benefits associated with physical activity,= Curr. Opin. Psychiatry, vol. 18, no. 2, 
pp. 1893193, 2005.
[19] 
G. M. Gasparri, J. Luque, and Z. F. Lerner, <Proportional Joint-Moment Control for 
Instantaneously Adaptive Ankle Exoskeleton Assistance,= IEEE Trans. Neural Syst. 
Rehabil. Eng., vol. 27, no. 4, pp. 7513 759, 2019.
[20] 
B. Provost et al., <Endurance and Gait in Children With Cerebral Palsy After Intensive 
Body WeightSupported Treadmill Training,= Pediatr. Phys. Ther., vol. 19, no. 1, pp. 23
10, 2007. 
[21] 
R. Aviram, N. Harries, I. Namourah, A. Amro, and S. Bar-Haim, <Effects of a group circuit 
progressive resistance training program compared with a treadmill training program for 
adolescents with cerebral palsy,= Dev. Neurorehabil., vol. 20, no. 6, pp. 3473354, Aug. 
2017.
[22] 
R. C. Browning, J. R. Modica, R. Kram, and A. Goswami, <The effects of adding mass to 
the legs on the energetics and biomechanics of walking,= Med. Sci. Sports Exerc., vol. 
39, no. 3, pp. 5153525, 2007.
IRB #: STU00215607 Approved by NU IRB for use on or after 6/10/2024 through 6/9/2025.

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
Page 1 of 35 
Template Revised On: 09/01/2019 
ANCILLARY REVIEWS 
 
Which ancillary reviews do I need and when do I need them? 
Refer to HRP-309 for more information about these ancillary reviews. 
Select yes or no 
Does your study& 
If yes& 
Impact on 
IRB Review 
6 Yes 
6 No 
 
Include Gillette resources, 
staff or locations 
Gillette Scientific review and Gillette 
Research Administration approval is 
required.  Contact: 
research@gillettechildrens.com   
Required 
prior to IRB 
submission 
6 Yes 
6 No 
Involve Epic, or Fairview 
patients, staff, locations, or 
resources? 
The Fairview ancillary review will be 
assigned to your study by IRB staff 
Contact: ancillaryreview@Fairview.org 
Approval 
must be 
received 
prior to IRB 
committee/ 
designated 
review.   
 
Consider 
seeking 
approval 
prior to IRB 
submission. 
6 Yes 
6 No 
Include evaluation of drugs, 
devices, biologics, tobacco, 
or dietary supplements or 
data subject to FDA 
inspection? 
The regulatory ancillary review will be 
assigned to your study by IRB staff 
Contact: medreg@umn.edu  
 
See: 
https://policy.umn.edu/research/indide  
6 Yes 
6 No 
 
Approved by 
Gillette 
Scientific 
Review 
 
Require Scientific Review? 
Not sure? See guidance on 
next page. 
 
Documentation of scientific merit must 
be provided.   
Contact: hrpp@umn.edu  
6 Yes 
6 No 
Relate to cancer patients, 
cancer treatments, cancer 
screening/prevention, or 
tobacco? 
Complete the CPRC application process.  
Contact: ccprc@umn.edu  
6 Yes 
6 No 
Include the use of 
radiation? 
(x-ray imaging, 
radiopharmaceuticals, 
external beam or 
brachytherapy) 
Complete the AURPC Human Use 
Application and follow instructions on 
the form for submission to the AURPC 
committee. 
Contact: barmstro@umn.edu  
Approval 
from these 
committees 
must be 
received 
prior to IRB 
approval;  
 
These 
groups 
6 Yes 
6 No 
Use the Center for 
Magnetic Resonance 
Research (CMRR) as a study 
location? 
Complete the CMRR pre-IRB ancillary 
review  
Contact: ande2445@umn.edu  

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
Page 2 of 35 
Template Revised On: 09/01/2019 
6 Yes 
6 No 
Include the use of 
recombinant or synthetic 
nucleic acids, toxins, or 
infectious agents? 
Complete the IBC application via 
eprotocol.umn.edu 
Contact: 
each have 
their own 
application 
process.  
6 Yes 
6 No 
Include the use of human 
fetal tissue, human 
embryos, or embryonic 
stem cells? 
Contact OBAO for submission 
instructions and guidance 
6 Yes 
6 No 
 
Approved by 
Gillette 
Compliance 
Review 
 
Include PHI or are you 
requesting a HIPAA waiver? 
If yes, HIPCO will conduct a review of 
this protocol. 
Contact: privacy@umn.edu  
6 Yes 
6 No 
Use data from the 
Information Exchange (IE)? 
The Information Exchange ancillary 
review will be assigned to your study by 
IRB staff 
Contact: ics@umn.edu  
Approval 
must be 
received 
prior to IRB 
approval. 
 
These 
groups do 
not have a 
separate 
application 
process but 
additional 
information 
from the 
study team 
may be 
required. 
 
6 Yes 
6 No 
Use the Biorepository and 
Laboratory Services to 
collect tissue for research? 
The BLS ancillary review will be 
assigned to your study by IRB staff. 
Contact: cdrifka@umn.edu  
6 Yes 
6 No 
Have a PI or study team 
member with a conflict of 
interest? 
The CoI ancillary review will be 
assigned to your study by IRB staff 
Contact: becca002@umn.edu  
6 Yes 
6 No 
 
Registration on 
clinicaltrials.gov 
will be 
managed by 
the prime 
site/sponsor 
(BiOMOTUM, 
Inc.) 
 
Need to be registered on 
clinicaltrials.gov? 
 
 
 
If you select <No= in ETHOS, the 
clinicaltrials.gov ancillary review will be 
assigned to your study by IRB staff 
Contact: kmmccorm@umn.edu  

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
Page 3 of 35 
Template Revised On: 09/01/2019 
 
 
PROTOCOL COVER PAGE 
 
 
 
 
6 Yes 
6 No 
Require registration in 
OnCore? 
If you select <No= or <I Don9t Know= in 
ETHOS, the OnCore ancillary review will 
be assigned to your study by IRB staff 
Contact: oncore@umn.edu  
Does not 
affect IRB 
approval. 
 
Protocol Title 
Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
Principal 
Investigator/Faculty 
Advisor 
Name: Michael H. Schwartz 
Department: Gillette Children9s Specialty Healthcare, Center for Gait and 
Motion Analysis; University of Minnesota, Department of Orthopedic 
Surgery 
Telephone Number: 651-229-3929 
Email Address: mschwartz@gillettechildrens.com; schwa021@umn.edu  
Student 
Investigator 
Name: N/A 
Current Academic Status (Student, Fellow, Resident): 
Department: 
Telephone Number: 
Institutional Email Address: 
Scientific 
Assessment 
Nationally-based, federal funding organizations 
 
Approved by Gillette Scientific Review 
IND/IDE # (if 
applicable) 
N/A 
IND/IDE Holder 
N/A 
Investigational Drug 
Services # (if 
applicable) 
N/A 
Version 
Number/Date: 
V11, 11/09/2022 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
Page 4 of 35 
Template Revised On: 09/01/2019 
REVISION HISTORY 
 
Revision # 
Version Date Summary of Changes 
Consent Change? 
10/11/2021 
v2 Addition of recruitment flyer 
No 
11/29/2021 
v3 Update language for experiments 
1 and 2; inclusion and exclusion 
criteria updated 
Yes 
02/01/2022 
V4 Update language for exploratory 
phase and experiments 1 and 2, 
addition of questionnaires to 
experiment 1 and 2; inclusion and 
exclusion criteria update; addition 
of UBACC to assess capacity to 
consent 
Yes 
03/02/2022 
v5 Addition of documentation of 
study participation (consent) in 
medical record; Update inclusion 
criteria 
Yes 
06/15/2022 
V6 Addition of mileage 
reimbursement 
Yes 
7/6/2022 
V7 Increase participant remuneration 
and addition of hotel 
reimbursement;  
Yes 
7/14/2022 
V8 Language for hotel reimbursement 
has been updated to reflect 
funding source policy 
Yes 
7/29/2022 
V9 Physical therapist added as part of 
initial contact to participant 
No 
9/13/2022 
V10 Update frequency and Surgery 
Requirement  
Yes 
11/09/2022 
V11 Update screening language 
Yes 
 
 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
Page 5 of 35 
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Table of Contents 
 
1.0 
Objectives 
7 
2.0 
Background 
7 
3.0 
Study Endpoints/Events/Outcomes 
9 
4.0 
Study Intervention(s)/Investigational Agent(s) 
9 
5.0 
Procedures Involved 
12 
6.0 
Data and Specimen Banking 
16 
7.0 
Sharing of Results with Participants 
17 
8.0 
Study Population 
18 
10.0 Local Number of Participants 
21 
11.0 Local Recruitment Methods 
21 
12.0 Withdrawal of Participants 
22 
13.0 Risks to Participants 
23 
14.0 Potential Benefits to Participants 
24 
15.0 Statistical Considerations 
24 
16.0 Health Information and Privacy Compliance 
26 
17.0 Confidentiality 
29 
18.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
30 
19.0 Provisions to Protect the Privacy Interests of Participants 
30 
20.0 Compensation for Research-Related Injury 
30 
21.0 Consent Process 
30 
22.0 Setting 
32 
23.0 Multi-Site Research 
32 
24.0 Coordinating Center Research 
33 
25.0 Resources Available 
33 
26.0 References 
33 
 
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MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
Page 6 of 35 
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ABBREVIATIONS/DEFINITIONS 
ï ABS 
 
Ankle brace system 
ï CP  
 
Cerebral Palsy 
ï EMG 
 
Electromyography 
ï GMFCS 
 
Gross Motor Function Classification System 
ï LAR 
 
Legally authorized representative 
ï MRN 
 
Medical Record Number 
ï PT   
 
Physical therapy; Physical therapist 
ï ROM 
 
Range Of Motion 
 
 
 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
Page 7 of 35 
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1.0 
Objectives 
1.1 Purpose:  
The purpose of this investigation is to establish the feasibility and efficacy of a 
lightweight, battery-powered ankle brace system (ABS) to improve mobility for 
individuals with cerebral palsy (CP). 
¥ Aim 1: Complete a personal-use feasibility analysis of the ABS. This aim will be 
completed by collaborators at Northern Arizona University and BiOMOTUM, 
Inc. (prime site/sponsor), and activities will be covered by a separate IRB 
protocol.  
¥ Aim 2: Gather feedback from Aim 1 to design and prototype a minimum viable 
ABS for use in clinical and community settings. This aim will be completed by 
collaborators at Northern Arizona University, Shirley Ryan Ability Lab, and 
BiOMOTUM, Inc., and activities will be covered by separate IRB protocols.  
¥ Aim 3: Quantify the potential for an ABS to increase the effectiveness of 
clinical gait therapy by targeted assistance and resistance training. This aim 
will be completed by Gillette Children9s Specialty Healthcare (Gillette), and 
activities will be covered by this IRB protocol.  
2.0 
Background 
2.1 Significance of Research Question/Purpose:  
Many of the 500,000 children in the United States with CP, the most common 
cause of pediatric physical disability, have difficulty walking and participating in 
physical activity. Half of all ambulatory children with CP lose the ability to walk 
independently in adulthood, indicating that the current approaches for treating 
these individuals do not result in meaningfully improved mobility over time. 
Physical therapy (PT) is essential for treating CP, but the amount of PT is generally 
insufficient, and the delivery of PT can be inefficient. There is currently no viable 
way to provide a sufficient dose of PT that will lead to long-term improvements in 
mobility and reduce the negative physical and social outcomes related to limited 
mobility and reduced physical activity. 
Due to the lack of available and sufficient treatment methods for improving 
mobility, the study team aims to establish the feasibility and efficacy of an ABS for 
assistance and resistance training. In the long-term, this research will improve our 
ability to optimize the prescription of wearable assistive devices to improve 
mobility and increase physical activity in individuals with movement disorders. 
2.2 Preliminary Data:  

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
Page 8 of 35 
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Past work completed by our collaborators has shown improvements in walking 
outcomes following treadmill and over-ground assistance interventions using a 
powered ABS. In a pilot study conducted using an instrumented treadmill, five 
participants with CP (5-30 years old) practiced walking at self-selected speeds 
with powered plantarflexor assistance. Participants exhibited a 19% reduction 
(p<0.05) in net metabolic cost of transport on average during treadmill walking 
with assistance compared to their baseline walking condition. Compared to 
baseline, participants also had reduced crouch by 14.4 ± 4 degrees (p<0.05) across 
the lower extremities, increased positive ankle power by 43.6 ± 7.4% (p<0.05), 
and decreased positive hip power by 29.2 ± 6.0% (p<0.01).1 All these changes are 
biomechanically favorable.  
Further, in a pilot study to test the powered ankle brace resistance therapy, 
participants completed 10 training sessions over 4 weeks with progressively 
increasing levels of resistance. Participants exhibited significantly improved 
(reduced) stance-phase ankle co-contraction by 29% ± 13% (p<0.04) and a more 
normal plantarflexor muscle activation profile by 30% ± 15% (p<0.02). 
Additionally, an increase in neural control complexity of walking after training was 
observed, which was significantly greater than a matched control group that 
underwent standard orthopedic and neurologic surgery alone. These 
improvements in neuromuscular control are indicative of a more mechanically 
efficient gait pattern, improved metabolic cost, and enhanced functional 
performance.2,3 
2.3 Existing Literature:  
Children with CP frequently experience a downward trend of reduced physical 
activity and worsening gait, leading to a permanent decrease or loss in 
ambulatory ability.4 For children with CP, walking is drastically more energetically 
expensive than for their typically developing peers.5 Experts have called for new 
ways to elevate activity levels in children with movement disorders.6,7 
The ankle joint plays a critical role during walking, acting to stabilize, support, and 
propel the body.8 Activation of the ankle plantarflexor muscles is reduced, less 
modulated, and often accompanied by co-activation of the antagonist dorsiflexor 
muscles in most individuals with spastic CP. Reduced ankle performance during 
walking in children with CP is suggested as a primary contributor to the observed 
gait dysfunction.9 Ankle plantarflexors of children with CP produce 50% less 
positive joint work than in typical gait,10 resulting in a reliance on more proximally 
located muscles for forward progression.11 These muscle activation characteristics 
likely contribute directly or indirectly to reduced energy exchange,12 elevated 
metabolic cost of transport,13 and lower levels of physical activity14 in this patient 
population. Evidence suggests that addressing or augmenting the neuromuscular 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
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deficits at the ankle may allow children with CP to engage in greater amounts of 
habitual physical, which would likely have many additional physical and mental 
health benefits.15,16 
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome:  
Activities collected at Gillette and will be split into an Exploration phase and an 
Experimental phase (split into Experiments 1 and 2), each with different 
outcomes: 
¥ Exploration: Qualitative participant assessment of device usability, 
device comfort, and ease of donning/doffing. 
¥ Experiment 1: Number of steps with mean late stance (i.e., propulsive) 
ankle plantarflexor activity above pre-session baseline average activity 
of 5 heel raises 
¥ Experiment 2: Preferred walking speed and similarity of muscle activity 
to the average unimpacted activity pattern calculated via cross-
correlation coefficient 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s): 
¥ Exploration: N/A 
¥ Experiment 1: Number of steps with mean stance phase ankle co-
contraction below pre-session baseline 
¥ Experiment 2: Metabolic cost; six-minute walk test (6MWT); timed up-
and-go test (TUG); gait kinematics and kinetics; stride-to-stride 
variability of lower-extremity muscle activity; variance accounted for by 
the first muscle synergy; plantarflexor muscle strength; 66-item Gross 
Motor Function Measure (GMFM-66) 
4.0 
Study Intervention(s)/Investigational Agent(s) 
4.1 Description:  
Both the Exploration and Experimental phases will test the use of the ABS within 
the context of device usability and ease (Exploration), therapy precision 
(Experiment 1), and assistance training (Experiment 2). Participants may partake 
in any study phase in which they are eligible, and participation in each 
experiment may take place in any order. 
Exploration: 
In the Exploration phase, participants will come to Gillette for up to two visits. 
These visits will include ABS fitting and acclimation to test device usability, device 
comfort, assisted vs. unassisted walking performance, and ease of 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
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donning/doffing. This exploratory work will allow participants to test the ABS, and 
a licensed physical therapist (PT) will be present. To explore a participant9s 
accommodation to the device, the PT, at their discretion, may use 
electromyography, metabolic measurements, and/or 10 m and 6 minute-walk-
tests. Participant, parent/guardian, and therapist questionnaires may be 
provided. If interested and eligible, they would be invited to participate in 
Experiments 1 and 2, although participation in the Exploration phase is not a 
requisite for participation in Experiments 1 and/or 2. 
 
Experiment 1: 
In Experiment 1, participants will come to Gillette for a baseline visit. This 
baseline visit will include ABS fitting and acclimation. Following the baseline visit, 
participants will return to Gillette for 3 additional visits in a randomized order: 
assistance visit, resistance visit, and typical gait therapy visit. During each visit, a 
licensed PT will guide participants through the following activities while collecting 
plantarflexor activity via surface electromyograph (EMG): 10 minutes of treadmill 
walking, 10 minutes of overground walking, and 15 minutes of walking skills 
practice (e.g., sideways, backward, stepping strategies, etc.). 
Experiment 2: 
In Experiment 2, participants will come to Gillette for a baseline visit. Like 
Experiment 1, this baseline visit will consist of ABS fitting and acclimation. 
Following the baseline visit, participants will return to Gillette for 12 visits with 
assistance training. Assistance training will include approximately 20-30 minutes 
of overground walking with assistance monitored by the PT; participants will 
complete three ~5-10-minute bouts of walking with seated rest periods in 
between. The research team will guide participants to walk at a moderate-to-high 
intensity for the duration of each walk as indicated by level 7 (<Hard=) on the 
Pictorial Children9s Effort Rating Table (PCERT).18 
After all assistance training visits are complete, participants will complete follow-
up visits at 3 days and 3 weeks post-training. At the baseline and follow-up visits, 
the participants will complete the following activities guided by a PT: standard 
three-dimensional gait analysis (e.g., metabolic cost, 6MWT, gait kinematics and 
kinetics, surface EMG, and physical examination), TUG, and GMFM-66 dimensions 
D and E (e.g., walking, running, and jumping activities).  

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
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Participants must complete at least 1 visit per week and miss no more than 3 
visits total.  
4.2 Drug/Device Handling:  
The ABS is a lightweight battery-powered ankle orthosis. The system includes a 
torque sensor, system controller, battery, cables, calf cuff and frame, foot plate, 
and sensor inserted in a shoe (Figure 1A). The complete ABS system has a total 
mass of 1.5 kg (70% of mass situated in a waist pack or backpack) and allows the 
user to move around freely (Figure 1B). 
 
The ABS provides a small amount of motorized assistance that is intended to 
augment existing activity. This and other similar investigational devices have been 
classified by the Food and Drug Administration as a nonsignificant risk device 
because they do not meet the definition of significant risk under 812.3(m) of the 
investigational device exemption (IDE) regulation (21 CFR 812 and outlined in 
HRP-418 Checklist: Non-Significant Risk Device). In other words, the ABS:  
¥ is not an implant; 
¥ is not supporting or sustaining life; 
¥ is not used for diagnosing/curing/mitigating/treating disease; and 
¥ does not present the potential for serious risk to health or safety.  
Additionally, several safety precautions are implemented to ensure participant 
safety, including mechanical <stops= to prevent hyperextension of joints, an 
emergency stop button that shuts off power to the device, and embedded 
software mechanisms that shut off power to the device if the user were to fall. 
Calf cuff 
Torque 
sensor 
Foot sensor 
Fig 1. Ankle Brace System 
(ABS). A. ABS with a torque 
sensor, calf cuff and frame, 
and foot plate and sensor to 
be inserted in a shoe. This is 
similar in size to a standard 
AFO. B. Complete ABS with 
waist battery pack, cables, 
and components in A. 
Participant is wearing the 
complete system while 
walking on a treadmill. Figure 
provided by collaborators at 
NAU.  
A 
B 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
Page 12 of 35 
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Following 21 CFR 812.2 (as outlined in HRP-307 Worksheet: Medical Devices), the 
ABS fits within the abbreviated IDE requirements as: 
¥ our activities are testing the safety and efficacy of the ABS; 
¥ it is a nonsignificant risk device;  
¥ it is not banned from use by the FDA; and  
¥ informed consent and documentation of informed consent will be 
obtained from all participants. A comment of study participation will be 
made in the participants medical record as communication with other 
hospital staff.  
 
Further, following the requirements for an abbreviated IDE, the investigator will 
follow regulations and reporting requirements as appropriate (21 CFR 812.150). 
At the end of the study, the investigator will be responsible for returning products 
to the prime site/sponsor and submitting a final report to the appropriate IRB. 
4.3 Biosafety: 
N/A 
4.4 Stem Cells: 
N/A 
4.5 Fetal Tissue: 
N/A 
5.0 
Procedures Involved 
5.1 Study Design:  
Prospective cohort study 
5.2 Study Procedures:  
Potential participants will be identified and screened by study team members by 
reviewing the Gillette medical record as well as the Gillette Center for Gait and 
Motion Analysis database and schedule. Potential participants may be contacted 
by introductory letter, phone call, or in-person during a standard of care clinic 
visit to determine interest in any phase of the study. If a potential participant is 
interested, study team members will follow-up to answer questions, determine 
eligibility, and schedule research visits as appropriate. 
All activities proposed in this protocol are for research purposes only. Potential 
participants will come to the Gillette for their research visits. Informed consent 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
Page 13 of 35 
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and assent will be obtained prior to any study activities as outlined below. Breaks 
will be provided to participants as needed. 
Exploration: 
For the Exploration phase, participants will come to Gillette for up to two visits. 
These visits will include ABS fitting and acclimation, which may take up to 60 
minutes each visit. Participants will walk with the unpowered and powered ABS 
to assess device usability, device comfort, and ease of donning/doffing. 
Additionally, they will complete a qualitative assessment to document their 
experience. This exploratory work will allow participants to test the ABS and 
provide feedback to investigators prior to the Experimental phase. A licensed PT 
will be present to assist as needed. If interested and eligible, participants of the 
Exploration phase would be invited to participate in Experiments 1 and 2, 
although this participation is not a requisite for Experiment 1 and/or 2 
participation. 
Experiment 1: 
For Experiment 1, participants will come to Gillette for a baseline visit. This 
baseline visit will include ABS fitting and acclimation, which will take roughly 60 
minutes. No full gait analysis is needed because comparison is primarily between 
the three sessions for relative changes in surface EMG. Participants will walk with 
the unpowered ABS to assess comfort and fitting. The device will be adjusted to 
fit each participant. A short unassisted/unresisted walking bout will be completed 
and the device further adjusted for comfort. Once fitted properly, each 
participant will walk for 10 minutes with resistance and 10 minutes with 
assistance. The magnitude of resistance and assistance will be gradually increased 
until the participant9s preferred levels are established. These levels will be 
recorded and used for the following visits. Breaks will be provided, as needed. 
Following the baseline visit, participants will return to Gillette for 3 additional 
visits over 3 weeks: assistance visit, resistance visit, and typical gait therapy visit. 
The order of these 3 visits, which will take roughly 90 minutes each, will be 
randomized. The visits will be conducted by a licensed PT. During each visit 
surface EMG electrodes will be placed, and instrumented insoles will be used in 
the participant9s shoes to record step count. Participants will complete a baseline 
walking trial on a treadmill at the same self-selected speed established on the 
first visit. The PT will guide participants through the following activities and 
collect the outcome measures listed in sections 3.1 and 3.2:  
¥ 10 minutes of treadmill walking with a focus on plantarflexor engagement 
and lower-extremity posture 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
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¥ 10 minutes of overground waking with a focus on stride length and inter-
limb symmetry 
¥ 15 minutes of walking skills practice (e.g., sideways, backward, stepping 
strategies, etc.) 
The study team will make every effort to have the same PT conduct all visits for 
each participant to minimize variability between sessions. The participant and PT 
will complete a questionnaire at the end of each session. 
Experiment 2: 
In Experiment 2, participants will come to Gillette for a baseline visit which will 
take roughly 120 minutes. Baseline visit will include a complete gait analysis and 
ABS fitting and acclimation. Additionally, this baseline visit will be used to collect 
outcome measures as described below.  
Following the baseline visit, participants will return to Gillette for 8-12 training 
visits over 4-8 weeks with assistance training, which will take roughly 30-60 
minutes each. During each of the training visits, participant will don the RAAD the 
PT will guide participants through the following activities (breaks will be provided, 
as needed): 
¥ Three bouts of ~5-10 minutes of overground walking with assistance at 
moderate-to-high intensity. 
After all assistance training visits are complete, participants will complete a 
follow-up visit at 3 days and 3 weeks post-training visits.  
During the baseline and follow-up visits, the PT will guide participants through the 
following activities and collect the outcome measures listed in sections 3.1 and 
3.2: 
¥ Three-dimensional gait analysis, which includes steady-state metabolic 
cost on a treadmill (if tolerated), 6MWT, gait kinematics and kinetics, 
markers and surface EMG, and physical examination and medical history 3 
Clinically validated method for collecting and analyzing gait and motion in 
the Gillette Center for Gait and Motion Analysis 
¥ TUG, which measures the time required to stand up for a standard arm 
chair, walk 3 meters, turn, walk back to the chair and sit down 3 Clinic 
measure of balance and functional mobility 
¥ GMFM-66, which measures gross motor activities across five dimensions 
such as lying/rolling, sitting, crawling/kneeling, standing, and 

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PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
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walking/running/jumping 3 Clinically validated assessment of changes in 
gross motor function of children with CP (CanChild) 
The study team will make every effort to have the same PT conduct all visits for 
each participant to minimize variability between sessions. 
On the first follow-up visit, we will assess subjective user experience and quantify 
the usability of the device. Each research PT, participant and parent/guardian will 
complete the System Usability Scale (SUS).19 The SUS includes 10 statements 
rated by means of a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly 
agree), and the SUS scores have a range of 0 to 100 that is divided by five scales: 
score of 0325: worst, score of 25339: poor, score of 39352: OK, score of 52385: 
excellent, and score of 853100: best imaginable.20 
We will ask the participant to complete a custom, open-ended questionnaire with 
the following questions. Subjects have the right to refuse to answer to any 
questions they feel uncomfortable answering and the research team will mark 
these questions as unanswered. 
(1) Did you see a benefit of training with the device?  
a. If yes, why?  
b. If not, why?  
(2) How did training with the device make you feel? 
(3) What were your favorite things about using the device?  
(4) What were your least favorite things about using the device? 
(5) Is there anything that would make the device better to use?  
We will ask the parent/guardian to complete a custom, open-ended 
questionnaire with the following questions. Parents/guardians have the right to 
refuse to answer to any questions they feel uncomfortable answering and the 
research team will mark these questions as unanswered. 
(1) Do you think your child enjoyed using the device? 
a. If so, what aspects were enjoyable?  
(2) How did you perceive training with the device made your child feel? 
(3) Do you think there could be a benefit for your child to use such a device 
regularly during therapy?  
a. If so, how?  
We will ask the lead research PT for each participant to complete a custom, open-
ended questionnaire with the following questions: 

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individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
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(1) Do you think the device was effective in improving the gait training activities 
for this participant? 
a. If so, how?  
b. If not, why? 
c. Was there anything particular to this participant that influenced your 
response?  
(2) Do you have any recommendations for how the device could have been 
more effective for this participant?  
5.3 Study Duration:  
Activities at Gillette will occur in years 2 and 3 of the overall award. Gillette is 
participating in Aim 3 of the overall award; previously described in section 1.1.  
Screening and recruitment at Gillette will take 6-12 months and data collection 
will take an additional 10-12 months.  
Data analysis and dissemination will occur in the last 6 months of the overall 
award. 
5.4 Use of radiation: 
N/A 
5.5 Use of Center for Magnetic Resonance Research: 
N/A 
6.0 
Data and Specimen Banking 
6.1 Storage and Access: 
Data will be stored electronically using secure methods and as hard copy forms in 
locked offices/file cabinets. Data collected as part of the three-dimensional gait 
analysis will be collected, stored, and processed in the Gillette Center for Gait and 
Motion Analysis database as standard practice. Other remaining data, such as 
demographic, ABS, or other research records will be stored in electronic and hard 
copy research records.  
Electronic data collected at Gillette will be stored and on secure Gillette shared 
internal networks, REDCap, and UMN Box. To minimize errors and ensure 
accurate data analysis, identifiable data will be shared with collaborators. This 
data sharing will be done using HIPAA-compliance methods like email and UMN 
Box throughout the study duration. 
After the study is complete, we will destroy direct identifiers and linking 
information but will retain and preserve de-identified data. Individual and 

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individuals with movement disorders 
 
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aggregate data may be shared publicly if required by federal regulation, funding 
agency, or publishing entities. 
6.2 Data:  
¥ Demographic and medical history - Data will be collected, stored, and 
processed electronically in research records and the Gillette Center for 
Gait and Motion Analysis database as standard practice. Data include, but 
is not limited to, demographic information, date of birth, height, weight, 
medical and surgical history, and diagnoses. 
¥ Three-dimensional gait analysis - Data will be collected, stored, and 
processed electronically in the Gillette Center for Gait and Motion Analysis 
database as standard practice. Data include TUG, gait kinematics and 
kinetics, 6MWT, surface EMG, and physical examination measures. 
¥ ABS - Data will be collected, stored, and processed electronically in 
research records. Data include, but is not limited to, level of assistance 
and resistance, and step count. 
¥ Other research records (e.g., enrollment logs, etc.) - Data will be collected, 
stored, and processed electronically in research records or saved as hard 
copy forms. Hard copy forms will be transcribed electronically as 
appropriate and will be stored in locked offices/file cabinets. 
6.3 Release/Sharing: 
Study-wide, team members are affiliated with either Gillette, Northern Arizona 
University, Shirley Ryan Ability Lab, or BiOMOTUM, Inc. Data collection related to 
Gillette participants will only occur at Gillette. Further, Gillette study team 
members have access to medical records as a function of their job duties.  
Identifiable data will be shared with collaborators (e.g., name, date of birth, date 
of service, diagnosis, etc.) using secure and HIPAA-compliant methods throughout 
the study duration, including encrypted email and UMN Box. 
After the study is complete, de-identified individual and aggregate data may be 
shared publicly in ways that will not identify the individual. This will follow federal 
regulation, funding agency requirements, and publishing requirements. 
7.0 
Sharing of Results with Participants 
7.1 Sharing of Results:  
Individual results will not be shared with participants. 
Periodic study updates may be mailed to participants. No individual responses 
will be shared in these summaries and all study updates will be IRB-approved 
prior to mailing. 

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PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
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8.0 
Study Population 
8.1 Inclusion Criteria:  
Exploration: 
¥ 8-21 years old 
¥ Height/weight/BMI between the 5th 3 95th percentile of children in the 
Gillette Center for Gait and Motion Analysis database 
¥ Able to walk for at least 6 minutes (assisted or unassisted) 
¥ Able to understand and follow simple directions 
¥ Able to safely fit into device configuration and tolerate assistance without 
knee hyperextension while walking 
 
Experiments 1 and 2: 
¥ Diagnosed with cerebral palsy 
¥ 8-21 years old 
¥ GMFCS I-III 
¥ Height/weight/BMI between the 5th 3 95th percentile of children with CP in 
the Gillette Center for Gait and Motion Analysis database 
¥ At least 20 degrees of passive ankle planter flexion range of motion 
¥ Able to complete at least 1 heel raise with minimal assistance (balance 
only) 
¥ Able to walk for at least 6 minutes (assisted or unassisted) 
¥ Able to understand and follow simple directions 
¥ Able to safely fit into device configuration and tolerate assistance without 
knee hyperextension while walking 
¥ Minimal invasive orthopedic surgery 
For Experiments 1 and 2, we will recruit an equal number of males and 
females, matched by age within 2 years. 
8.2 Exclusion Criteria:  
Exploration: 
¥ Consenting individual and participant non-English speaking and reading 
¥ Total knee or ankle ROM less than 15 degrees at each joint 
¥ Health condition or diagnosis other than CP that would affect safe 
participation  
¥ Orthopedic surgery completed in the past 12 months 
¥ Current enrollment in a conflicting research study 
Experiments 1 and 2: 
¥ Consenting individual and participant non-English speaking and reading 
¥ Total knee or ankle ROM less than 15 degrees at each joint 

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individuals with movement disorders 
 
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¥ Health condition or diagnosis other than CP that would affect safe 
participation  
¥ Major orthopedic surgery completed in the past 12 months 
¥ Current enrollment in a conflicting research study 
8.3 Screening:  
A list of potential participants will be generated from Gillette medical record and 
Gillette Center for Gait and Motion Analysis database and schedule. Potential 
participants may also be referred to study staff by hospital providers or through 
recruitment flyers and social media. Data stored in the Gait and Motion Analysis 
database will be used to determine eligibility. Potential participants will be 
screened for eligibility by delegated and trained study team members. Potential 
participants that are determined eligible will be contacted by introductory letter, 
phone call, and/or in-person during a standard of care clinic visit to determine 
interest. If a potential participant is interested, study team members will follow-
up to answer questions, determine eligibility, and schedule research visits as 
appropriate. If a potential participant does not have previous data in the Gait and 
Motion Analysis database, they will be asked to come in for a screening visit to 
determine if the device fits and determine eligibility. Individuals who come in for 
a screening visit will be asked to complete a consent form regardless of whether 
they are enrolled into the study or not. 
9.0 
Vulnerable Populations 
9.1 Vulnerable Populations:  
Population / Group 
Identify whether any of the 
following populations will be 
targeted, included (not necessarily 
targeted) or excluded from 
participation in the study.  
Children 
Targeted Population 
Pregnant women/fetuses/neonates 
Excluded from Participation 
Prisoners 
Excluded from Participation 
Adults lacking capacity to consent 
and/or adults with diminished 
capacity to consent, including, but 
not limited to, those with acute 
medical conditions, psychiatric 
Excluded from Participation 

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PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
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disorders, neurologic disorders, 
developmental disorders, and 
behavioral disorders 
Non-English speakers 
Excluded from Participation 
Those unable to read (illiterate) 
Excluded from Participation 
Employees of the researcher 
Excluded from Participation 
Students of the researcher 
Excluded from Participation 
Undervalued or disenfranchised 
social group 
Included/Allowed to Participate 
Active members of the military 
(service members), DoD personnel 
(including civilian employees) 
Excluded from Participation 
Individual or group that is 
approached for participation in 
research during a stressful situation 
such as emergency room setting, 
childbirth (labor), etc. 
Excluded from Participation 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
Included/Allowed to Participate 
Individual or group with a serious 
health condition for which there are 
no satisfactory standard treatments. 
Excluded from Participation 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
Included/Allowed to Participate 
Any other circumstance/dynamic 
that could increase vulnerability to 
coercion or exploitation that might 
Excluded from Participation 

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PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
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influence consent to research or 
decision to continue in research. 
 
9.2 Additional Safeguards: 
Cerebral palsy is a common neuromuscular disorder that develops during 
childhood and persists throughout the lifetime. Diagnosis, medical decision-
making, and treatment often occur during childhood and adolescence, making 
children the population of interest. 
This study involves no greater than minimal risk, so only one legally authorized 
representative (LAR) will provide consent for the minor participant. It will be 
communicated to participants and their LAR that participation in the research 
study is voluntary during the informed consent process. The child participant or 
LAR can indicate if they wish to discontinue participation at any point. 
10.0 Local Number of Participants 
10.1 Local Number of Participants to be Consented:  
In total, up to 50 participants may be consented into the study conducted at 
Gillette, which includes the Exploration phase and Experimental phase. 
Up to 20 participants may be consented into the Exploration phase. This is a 
sample of convenience and is preparatory to Experiments 1 and 2. 
Up to 15 participants may be consented into each Experiment (i.e., up to 30 total) 
to account for possible attrition and incomplete data. This will ensure we reach 
our recruitment goal of 12 enrolled participants with complete data in each 
Experiment.  
11.0 Local Recruitment Methods 
11.1 Recruitment Process:  
Gillette study team members may contact potential participants via an 
introductory letter and recruitment flyer, phone call, and/or in-person during a 
standard of care visit to explain study and determine interest. If a potential 
participant is interested, study team members will follow-up to answer questions, 
determine eligibility, and schedule research visits as appropriate. Email 
communication will be utilized when possible. 
11.2 Identification of Potential Participants:  
Potential participants will be identified through a screening of the Gillette medical 
record and the Gillette Center for Gait and Motion Analysis database and 
schedule. Gillette study team members have access to the medical record as a 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
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function of their job duties, and trained research team members are permitted to 
review PHI for activities preparatory to research. No PHI will be removed from 
Gillette and only the information necessary to determine study eligibility will be 
used.  
The study coordinator and/or study physical therapist at Gillette will be the 
primary study team members contacting potential participants to introduce the 
study. However, any study team member at Gillette indicated as being involved in 
consent may contact participants as well. 
Of note, collaborators will not be involved with participant contact or activities. 
11.3 Recruitment Materials:  
A study team member, most often the study coordinator and/or physical 
therapist, will make initial contact with potential participants by sending an 
introductory letter and recruitment flyer, discussing in-person during a standard 
of care visit, and/or calling on the phone.  
11.4 Payment:  
For participants in the Exploration phase, they will not receive compensation. For 
participants in Experiment 1, they will receive $50 compensation per visit for 4 
visits ($200 per participant). For participants in Experiment 2, they will receive 
$40 compensation per visit for 15 visits ($600 per participant). These dollar 
amounts are similar to past Gillette studies with similar time and effort 
commitments. Additionally, participants will be reimbursed for roundtrip mileage 
at the current federal rate. Hotel and parking will be offered to families that 
travel overnight and are traveling from a distance of 100 miles or more from 
Gillette. Hotel and parking costs will be covered up to the current federal rate. A 
Gillette travel agent will help book each participants hotel stay.  
Payment will be made via the Greenphire ClinCard, and appropriate language 
describing the Greenphire ClinCard has been added to the consent forms as 
appropriate. 
12.0 Withdrawal of Participants 
12.1 Withdrawal Circumstances:  
Participants will be withdrawn if they are later identified as not meeting the 
inclusion criteria (e.g., identified as eligible in error), if they miss more than 3 
research visits in a given Experiment, or if they decide to stop participating in the 
study. 
12.2 Withdrawal Procedures:  

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
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If a participant consents to the study but elects to stop participating after data 
collection has started, any data that was collected will be retained unless the 
participant asks otherwise.  
Participants must alert the study team in writing of their request to be withdrawn 
from the study. 
12.3 Termination Procedures:  
Data collected and completed up to the point of withdrawal or termination will 
still be included in the study unless the participant asks otherwise. 
13.0 Risks to Participants 
13.1 Foreseeable Risks:  
The potential minimal risks associated with this study are as follows:  
First, is the risk of falling during ambulatory activities performed during this 
protocol but this is no greater than during normal daily life. Additionally, this risk 
will be minimized by supervision from a licensed PT and the use of a safety 
harness and/or walker for unstable participants.  
Second, is the risk of fatigue, shortness of breath, or muscle soreness during or 
after the research visits. It is expected that when these symptoms occur, they will 
be minor and brief. If a participant experiences excessive shortness of breath or 
fatigue, they will be allowed to stop and given adequate rest before continuing. 
Should the participant experience any muscle soreness, light stretching, and 
hot/cold therapy will be recommended to reduce soreness. If these approaches 
do not alleviate the soreness, we will advise the use of OTC pain relievers (e.g., 
aspirin, acetaminophen, ibuprofen), unless contraindicated. As previously 
mentioned, a licensed PT will be present at each research visit. 
Third, there is a risk of stumbling or falling while walking with the ABS. The 
amount of ankle assistance/resistance is not designed or able to completely over-
power the user. As previously mentioned, several safety precautions are 
implemented to ensure participant safety, including mechanical <stops= to 
prevent hyperextension of joints, an emergency stop button that shuts off power 
to the device, and embedded software mechanisms that shut off power if the 
user were to fall. Lastly, a licensed PT will be present at each research visit. 
Fourth, there is a small risk of loss of confidentiality as part of participating in 
research. Study team members are trained on appropriate data use and storage, 
and every reasonable effort is made to minimize risk associated with loss of 
privacy and confidentiality. 
13.2 Reproduction Risks: 

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individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
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N/A 
13.3 Risks to Others: 
N/A 
14.0 Potential Benefits to Participants 
14.1 Potential Benefits:  
Potential benefits for this study include determining if wearable ankle assistance 
or resistance are viable treatment strategies for our participants, which can be 
used to guide future treatments and therapy and possible improvement in 
mobility. 
15.0 Statistical Considerations 
15.1 Data Analysis Plan: 
Data will be collected and analyzed by Gillette study team members and 
collaborators.  
Exploration: 
As described below, the Exploration phase is a sample of convenience, and these 
activities are preparatory to the Experimental phase. 
Experiments 1 and 2: 
For Experiments 1 and 2, power analyses were used to determined estimated 
sample sizes. Statistical procedures include Repeated Measures ANOVA (RM-
ANOVA) and generalized linear models. Participants in each Experiment will be 
age-, GMFCS-, and sex-matched as appropriate to control for known and 
unknown covariates. Participant demographics and baseline characteristics will 
also be analyzed. 
15.2 Power Analysis:  
Exploration: 
No power analysis was done for the Exploration phase; this is a sample of 
convenience. 
Experiment 1: 
The sample size for the primary outcome measure in Experiment 1, mean stance 
phase plantar-flexor activity, was determined for the Repeated Measures ANOVA 
(RM-ANOVA). We set the Type II error rate (beta) at 0.2, and therefore the power 
level at 0.8 and alpha at 0.05. Sample size was determined based on the 
difference in soleus activity (45 ± 35%) from our collaborators preliminary ABS 
resistance validation study. We found that a subject sample size of n = 10 will 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
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allow us to find significance. We will enroll and collect complete data for 12 
participants to provide an adequate sample for our investigation into participant 
characteristics that will be correlated with outcomes. 
Experiment 2: 
The sample size for the primary outcome measures in Experiment 2 was 
determined for the RM-ANOVA using our preliminary over-ground RAAD 
assistance training study (speed: 24±10%; normality of soleus profile: 39±20%; 
see section 2.2 Preliminary Data). We found that a sample size of n = 5 will allow 
us to find statistical significance for the assistance training protocol. We will enroll 
12 participants to provide an adequate sample for our investigation into 
participant characteristics (i.e., covariates) that will be correlated with outcomes. 
15.3 Statistical Analysis:  
Exploration: 
For the Exploration phase, qualitative data will be collected to assess device 
usability, device comfort, and ease of donning/doffing. There is no formal 
statistical analysis plan as this phase is only preparatory for Experiments 1 and 2. 
Experiment 1: 
For Experiment 1, RM-ANOVA will be used to compare our outcome measures 
between each RAAD condition and unassisted therapy. A <clinically-relevant= 
improvement will be defined as an improvement of 10%, or more, over baseline 
for each outcome measure. Cohen9s d will be used to calculate effect size.17 To 
account for sex as a biological variable, we will recruit an equal number of males 
and females, matched by GMFCS and age within 2-years. We will use a 
generalized linear model to determine if participant characteristics and delivery 
any potential interactions mode (assistance vs. resistance) significantly contribute 
to our outcome measures. 
Experiment 2: 
For Experiment 2, RM-ANOVA will be used to compare the change in our outcome 
measures across assessments. Additionally, a generalized linear model will be 
used to determine the participant characteristics that significantly contribute to 
our outcome measures (e.g., sex, age, spasticity, gender, height, GMFCS level), 
and any potential interactions with delivery mode (assistance vs PT-guided 
resistance vs PT-&-parent-guided resistance). Similar to the other Experiment, to 
account for sex as a biological variable, we will recruit an equal number of males 
and females within each GMFCS level, matched by age within 2-years, and include 
sex in the generalized linear model. Cohen9s d will be used to calculate effect 
size.17 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Development of a robotic ankle assist device to improve mobility in 
individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
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15.4 Data Integrity:  
Data integrity and quality control will primarily be done by the site principal 
investigator (PI Schwartz) and the prime site/sponsor (BiOMOTUM, Inc.) through 
periodic review. Data will also be reviewed through routine monitoring by the 
Gillette internal monitoring program or similar.  
16.0 Health Information and Privacy Compliance  
16.1 Select which of the following is applicable to your research: 
6 My research does not require access to individual health information and 
therefore assert HIPAA does not apply.   
6 I am requesting that all research participants sign a HIPCO approved HIPAA 
Disclosure Authorization to participate in the research. The stand alone 
HIPAA Authorization will be used. 
6 I am requesting the IRB to approve a Waiver or an alteration of research 
participant authorization to participate in the research. 
Appropriate Use for Research: N/A 
6 An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the 
U of M stand-alone HIPAA Authorization.  Note: External IRB must be serving 
as the privacy board for this option. 
16.2 Identify the source of Private Health Information you will be using for your 
research (Check all that apply)   
6 I will use the Informatics Consulting Services (ICS) available through CTSI 
(also referred to as the University's Information Exchange (IE) or data 
shelter) to pull records for me 
6 I will collect information directly from research participants. 
6 I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) database. 
6 I will pull records directly from EPIC. 
6 I will retrieve record directly from axiUm / MiPACS 
6 I will receive data from the Center for Medicare/Medicaid Services  
6 I will receive a limited data set from another institution  

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individuals with movement disorders 
 
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6 Other. Describe: Information will be collected from the Gillette medical 
record. LAR will sign a HIPAA Authorization as part of this research 
allowing study team members to access the participant9s medical record. 
16.3 Explain how you will ensure that only records of patients who have agreed to 
have their information used for research will be reviewed. 
Only the records of participants that have signed the consent form and HIPAA 
Authorization will be used for data collection and analysis associated with this 
research. Oversight of this will primarily be done by the site PI (PI Schwartz). All 
study team members will have been appropriately trained on HIPAA practices, 
obtaining authorization, and any related requirements prior to any participant 
interaction and research activities. 
16.4 Approximate number of records required for review: 
N/A 
16.5 Please describe how you will communicate with research participants during the 
course of this research.  Check all applicable boxes 
6 This research involves record review only. There will be no communication 
with research participants. 
6 Communication with research participants will take place in the course of 
treatment, through MyChart, or other similar forms of communication used 
with patients receiving treatment.  
6 Communication with research participants will take place outside of 
treatment settings.  
  
 
Communication with potential and enrolled participants will be done via 
phone, email, and/or in-person. This will be outside the context of standard 
of care treatment, and may include inquiring about study interest, 
reminding of upcoming appointments, or contacting for follow-up after 
participation. 
 
16.6 Explain how the research team has legitimate access to patients/potential 
participants 
 
All study team members at Gillette have access to the Gillette medical record as a 
function of their job duties. Participants will be told that their PHI will be used for 
this research, and a LAR will be asked to sign a HIPAA Authorization before 
research participation.  
 

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individuals with movement disorders 
 
VERSION DATE: 11/09/2022 
 
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16.7 Location(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply).   
6 In the data shelter of the Information Exchange (IE)  
 6 Store 
6 Analyze 
6 Share 
6 In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database  
 6 Store 
6 Analyze 
6 Share 
6 In REDCap (recap.ahc.umn.edu)  
 6 Store 
6 Analyze 
6 Share 
6 In Qualtrics (qualtrics.umn.edu) 
 6 Store 
6 Analyze 
6 Share 
6 In OnCore (oncore.umn.edu)  
 6 Store 
6 Analyze 
6 Share 
6 In the University9s Box Secure Storage (box.umn.edu) 
 6 Store 
6 Analyze 
6 Share 
6 In an AHC-IS supported server. Provide folder path, location of server and IT 
Support Contact: 
 6 Store 
6 Analyze 
6 Share 
6 In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices:  
 6 Store 
6 Analyze 
6 Share 
6 Other. Describe:  
In addition to the above methods, data will be collected, stored, processed, and 
shared within secure Gillette shared internal networks and on password 
protected computers. Research data and activities include, but are not limited 
to, information outlined in sections 6.1 and 6.2. 
6I will use a server not previously listed to collect/download research data 
6I will use a desktop or laptop not previously listed 
6I will use an external hard drive or USB drive (<flash= or <thumb= drives) not 
previously listed  

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individuals with movement disorders 
 
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6I will use a mobile device such as a tablet or smartphone not previously listed 
16.8 Consultants. Vendors. Third Parties.  
N/A 
16.9 Links to identifiable data:  
A study ID will be assigned to participants as they are enrolled. This will be linked 
to the identified data. Identifiers will remain on the data until all data analyses 
are complete and the study is closed with the IRB, at which time the key will be 
destroyed following institutional practices. After the study is complete, research 
records will be stored long-term following institutional practices, and de-
identified information will be retained and preserved indefinitely. If required, de-
identified data may be saved or shared in a publicly accessible manner. 
16.10 Sharing of Data with Research Team Members: 
Study team members at Gillette and collaborators will have access to the data 
collected as part of this research. Study team members at Gillette will share data 
internally through secure Gillette shared internal networks on password 
protected computers. Identifiable information shared with collaborators will be 
shared using secure and HIPAA-compliant methods such as encrypted email and 
UMN Box. 
16.11Storage and Disposal of Paper Documents: 
Hard copy forms will be stored in locked offices/file cabinets at Gillette. When the 
study is complete, hard copy documents will be stored following standard 
regulatory practices on and offsite. When that period has expired, hard copy 
forms will be destroyed following standard institutional practices. 
17.0 Confidentiality 
17.1 Data Security:  
All study team members will be appropriately trained, and training will be 
documented prior to any participant activity and data collection. Research data 
will be stored, shared, and accessed using secure methods to ensure data 
security. 
Relevant research data will be stored in research records and Gillette Center for 
Gait and Motion Analysis database, similarly to how data are stored and 
processed for standard of care at Gillette. 
Additionally, all research activities are covered under a certificate of 
confidentiality. Appropriate language describing the protections provided by the 
certificate will be added to the consent form. 

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individuals with movement disorders 
 
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18.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
18.1 Data safety and integrity Monitoring: 
This study is no greater than minimal risk. Therefore, the site PI (PI Schwartz) and 
prime site/sponsor (BiOMOTUM, Inc.) will be responsible for monitoring data 
integrity and will periodically check data collection, entry, adverse events, and 
study progress. Data will also be reviewed through regular and routine 
monitoring through the Gillette internal monitoring program or similar, and all 
activities will follow abbreviated IDE requirements.  
19.0 Provisions to Protect the Privacy Interests of Participants 
19.1 Protecting Privacy:  
All research data and analyses will be stored on password-protected computers, 
within secure Gillette shared internal networks, and shared with collaborators 
using secure methods as previously described. Study team members have been 
trained on institutional data security, HIPAA regulations, and appropriate 
computer use. 
Research records will be maintained at Gillette for the duration of the study and 
until the study is closed with the IRB. The site PI (PI Schwartz) at Gillette will 
primarily be responsible for managing the data collected at Gillette. 
19.2 Access to Participants:  
Participants9 parent/guardian will be informed about researchers9 need to access 
their child9s medical record for the purpose of this study and will be asked to sign 
a HIPAA Authorization. They will be told that participation is voluntary. 
20.0 Compensation for Research-Related Injury 
20.1 Compensation for Research-Related Injury: 
In the event that the research activity results in an injury, treatment will be 
available, including first aid, emergency treatment and follow-up care as needed. 
Care for such injuries will be billed in the ordinary manner to the participant9s 
insurance company. If they think that they have suffered a research related 
injury, they will let study team members know right away. 
20.2 Contract Language:  
N/A 
21.0 Consent Process 
21.1 Consent Process (when consent will be obtained):  

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Gillette study team members that are trained and delegated will obtain informed 
consent in-person and in a private setting at Gillette.  
The LAR will be asked to sign a consent form for each phase the participant will 
complete (e.g., Exploration and/or Experimental). Participants 8 to 17 years old 
with no or mild cognitive impairment will be asked to sign an assent form. If a 
participant is unable to sign an assent form due to cognitive or physical abilities, 
verbal assent (e.g., physical or verbal cues) will be obtained and documented as 
appropriate. If the LAR indicates that the child has more than mild cognitive 
delays, assent will not be obtained and will be documented as appropriate. A 
comment of study participation will be made in the participants medical record as 
communication with other hospital staff. 
21.2 Waiver or Alteration of Consent Process (when consent will not be obtained):  
N/A 
21.3 Waiver of Written/Signed Documentation of Consent (when written/signed 
consent will not be obtained):  
N/A 
21.4 Non-English-Speaking Participants:  
N/A 
21.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years 
of age): 
We will use the Gillette medical record to extract date of birth to determine that 
potential participants qualify. 
Further, informed consent will only be obtained from one LAR because the study 
constitutes no greater than minimal risk. 
There is no regulation on the exact age at which a child is required to complete a 
written assent. For our study, we have chosen to consent children (with no or 
mild cognitive impairment) who are ages 8 to 17 years old and should be able to 
understand the relatively simple study activities. If a participant can write, written 
assent will be obtained. If not, physical or verbal cues will be documented as 
assent when possible and appropriate.  If the LAR indicates that the child has 
more than mild cognitive delays, assent will not be obtained and will be 
documented as appropriate. 
21.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent: 
N/A 

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21.7 Adults Unable to Consent: 
N/A 
22.0 Setting 
22.1 Research Sites:  
Gillette is one of 3 collaborative sites which include Northern Arizona University 
and Shirly Ryan Ability lab and overseen by the prime site/sponsor BiOMOTUM, 
Inc.  
The site PI (PI Schwartz) will lead all activities conducted at Gillette and outlined 
in this protocol. 
22.2 International Research:  
N/A 
23.0 Multi-Site Research 
23.1 Study-Wide Number of Participants:  
Up to 86 participants will be recruited study-wide (12 from Northern Arizona 
University, 24 from Shirley Ryan Ability lab, and 50 from Gillette) 
23.2 Study-Wide Recruitment Methods:  
Norther Arizona University will be recruiting participants in Aim 1 and Shirley 
Ryan Ability Lab will be recruiting participants in Aim 2 using standard 
institutional methods. These activities are covered by separate IRB protocols and 
are not described here.  
Gillette will be recruiting participants for Aim 3 using methods described above. 
The site PI (PI Schwartz) will be responsible for these activities.  
23.3 Study-Wide Recruitment Materials:  
N/A 3 Each institution is responsible for their own recruitment materials.  
Materials for the activities completed at Gillette are included with this 
submission. 
23.4 Communication Among Sites: 
This collaborative study will be run by the lead investigator Dr. Raymond 
Browning CEO of BiOMOTUM, Inc. and Dr. Zachary Lerner at Norther Arizona 
University and BiOMOTUM, Inc. Dr. Michael Schwartz is co-investigator on the 
award and will act as the Gillette site PI. 
Study sites participate in regular video conferences, which will continue 
throughout the study duration. 

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Web-based and in-person trainings between sites will occur as time and 
schedules permit. This training will be documented, and data collection will not 
occur until all study team members are appropriately trained on the study 
protocol. Study monitoring of Gillette activities will be conducted through the 
Gillette internal monitoring program or similar. Non-compliance and reportable 
events will be reported following federal regulation, as necessary. 
23.5 Communication to Sites:  
Problems and interim results will be communicated during regular video 
conferences or additional electronic and telephonic communication, as necessary. 
Non-compliance and reportable events will be reported following federal 
regulation, as necessary. 
24.0 Coordinating Center Research 
N/A 
25.0 Resources Available 
25.1 Resources Available:  
Gillette is positioned to contribute to successful completion of this proposed 
project because of its one-of-a-kind comprehensive, integrated team approach to 
the treatment of individuals with CP. Specifically, this study will make use of the 
Gillette Center for Gait and Motion Analysis. Study participants will be recruited 
from the Gillette population, which sees over 2,000 children and adolescents with 
CP annually. This represents one of the largest pools of patients with CP in the 
nation and will ensure adequate recruitment of participants for the proposed 
study. 
26.0 References 
 
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3. R. Aviram, N. Harries, I. Namourah, A. Amro, and S. Bar-Haim, <Effects of a group 
circuit progressive resistance training program compared with a treadmill training 
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