Development of a Multifunctional Rehabilitation Standing and Stepping Device for Persons With Parkinson's Disease
Phase: NA
Conditions: Parkinson Disease
Sponsor: University of Michigan

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
Development of a Multifunctional Rehabilitation Device for Persons With Parkinson’s 
Disease 
NCT05586490 
6/18/2024

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
BACKGROUND 
Mobility, cognitive problems and common medical comorbidities in PwP: Postural instability and gait 
disturbances (PIGD) are a common (falls 37.2%, freezing of gait 16%) i and a significant cause of disability and 
reduced quality of life in PwP (1-3). Quality of life is further compromised by fear of falling resulting in reduced 
physical activity and increasing sedentariness (4). Although PT can be very effective, economic (healthcare 
costs) or patient (therapy adherence) barriers undermine long-term outcomes (5). A Cochrane review showed 
that effects of PT quickly faded within 1-3 months in PwP (6). Fortunately, new trends emphasize the 
importance of post-rehabilitation in-home interventions that have the potential for long-term adherence 
and sustained benefits (7-9). Cognitive impairment is another major source of disability and lower quality of life 
in PwP with point prevalence of MCI of 40% (10) and a major risk factor for dementia in PwP. Importantly, there 
are shared pathophysiologies between mobility disturbance and cognitive impairment, where PIGD 
motor features are a major risk factor for development of dementia in PwP (11). Mechanistically, the overlap 
between mobility disturbance and cognitive impairment can be explained because sensorimotor integration to 
maintain postural control is heavily dependent on sufficient allocation of attentional resources (12-14). 
Therefore, neural pathways subserving attention are critical for effective postural control and gait 
functions (15, 16), For example, safe ambulation and navigation functions require a combination of afferent 
information processing, automatic movement processes, and situations-specific corrections or adjustments (17). 
Consequently, the development of mobility problems reflects an increased need for cognitive control of 
previously automated actions (18, 19). Apart from cognitive impairment, common medical comorbidities (esp. 
metabolic syndrome/diabetes, frailty/sarcopenia and age-associated vestibular dysfunction) further aggravate 
PIGD motor features in PwP. Therefore, successful and effective rehabilitation interventions need to target each 
of these mechanistic factors when present in a PwP. 
Critical knowledge gap: Although PT may improve mobility functions in PwP in the short-term, there are 
currently no cost effective and sustainable approaches to ensure long-term success.  
Problem to be solved: Novel approaches are needed to ensure sustainable long-term outcomes of PIGD 
programs in PwP by targeting the current dilemmas of intermittent series of PT: (i) healthcare costs of PT; (ii) 
limited sustained long-term adherence of patients to post-PT physical activity instructions, (iii) lack of emphasis 
on sedentariness, and  (iv) lack of routine PT to integrate walking therapy with cognitive-motor dual tasks. 
Specific Aim: To develop and clinically test a Multifunctional Rehabilitation Standing and Stepping 
Device (MRSSD) prototype. We will develop a multidirectional MRSSD system based on a rotary motor 
propulsion system to enable multidirectional stepping therapy integrated with desktop activities requiring 
cognitive attention. Data from initial user acceptance studies will provide design feedback for optimized use in 
the PwP target population. Preliminary motor and cognitive effectiveness will be tested in a 12-week (plus or 
minus one week) randomized controlled in-home pilot clinical trial comparing the MRSSD to a static desk & 
control groups to provide preliminary data to power a large-scale clinical trial in phase II.  
 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
Methods 
Human Subjects, Recruitment, and Informed Consent:  
 
Eligibility criteria: PwP (n=45, as close to equal number of females/males as possible); age 50 years and over). 
Diagnosis of PwP is based the UK Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) 
criteria (20) with evidence of at least one of the following PIGD motor features (slow gait, imbalance, falls, 
freezing of gait) and/or MCI (21). Medical comorbidities of metabolic changes, DM, frailty/sarcopenia or age-
associated vestibular changes are allowed (22-24). 
 
Exclusion criteria: 
1. PD dementia (based on the Emre et al. diagnostic criteria (25) - cognitive and instrumental activities of daily 
living assessment); 
2. Parkinsonism plus syndromes;  
3. Inability to stand, step or walk without an assistive device;  
4. History of symptoms in stance that preclude safe and comfortable participation, such as severe dizziness 
and lightheadedness, severe orthostasis, severe symptomatic leg or back musculoskeletal pain, painful 
neuropathy, significant ankle edema or medication side effects;  
5. History of symptomatic cardiovascular or pulmonary disease interfering with stance;  
6. History of active rheumatic arthritis;  
7. History of uncontrolled chronic pain syndrome;  
8. Any other history of medical or psychiatric comorbidity precluding safe participation in the project;  
9. Venous stasis or severe varicosities. 
 
Subject Recruitment: Prior to any research procedures, written informed consent will be obtained from each 
subject followed by initial study eligibility email 
. PwP subjects will be recruited from the University of Michigan Functional Neuroimaging, Cognitive & Mobility 
Laboratory and from Dr. Richardson's clinical practice in Physical Medicine & Rehabilitation. Our laboratory has 
already collected a waiting list of volunteers who have expressed interest in this or similar studies. Additional 
recruitment strategies are detailed in the Recruitment & Retention clinical form. 
 
 
Test Sites: 
There will be two test sites where these studies can be conducted: in participant’s home offices and the 
Functional Neuroimaging, Cognitive, and Mobility Laboratory (fNiCoMo) at Domino’s Farms. 
 
Research Design and Methods: 
 
The main aims of this STTR are (i) to develop the 
new 
multifunctional 
rehabilitation 
desk 
(MRSSD); (ii) perform a clinical acceptance 
study in the target population, and (iii) collect 
preliminary motor and cognitive effectiveness 
data in a randomized MRSSD vs. regular static 
standing desk in a 4-month in-home pilot clinical 
trial in PwP.  
MRSSD Design: We have developed a concept 
design for an MRSSD prototype that will form the 
basis for further development (Figure 1). Several 
design criteria have been identified that the 
MRSSD will need to meet (Table 1). The motion 
of the tabletop is created by a system of motors 
and gears. The rotational motors have a gear screwed onto their shafts and will spin along with the motor shaft 
rotation. The teeth of the gear interlocks with a gear rack to propel the gear rack (and everything it is attached 
 
Figure 1. Design concept of the new MRSSD prototype 
reflecting a glass-view of propulsion system (left) and 
exploded view of the tabletop propulsion system (right). 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
to) in a linear but adjustable direction. The transfer bearings, clamps, and slider assemblies support the weight 
of the table while also allowing the tabletop to move in a safe and confined path. The middle frame is used to 
spatially separate the X-axis motion from the Y-axis motion while also connecting them to allow tabletop 
movement in diagonal, circular, and square patterns. We will adhere to ISO (14971) and IEC (60601) 
International Standards to ensure safety, reliability, and quality use. 
 
Table 1. Overview of critical user needs, requirements, and specification for MRSSD prototype development 
during Phase I. 
User need 
Requirement 
Specification 
Stepping 
movements 
Prompts multi-directional motion. 
• 
Drives user movement in left-right, forward-
backward, combined and non-linear pattern 
directions. 
Users take > 3 steps per minute at ~2.5 mm/s. 
Safety 
Device is level, does not vibrate, and 
does not tip or fall. 
• 
Device does not tip with 50 kg load at edge 
of tabletop at 25 cm excursion distance. 
Vibration on tabletop surface < 0.1m/s2 during 
use. 
 
Device is electrically safe. 
Device functions in range of conditions as 
described by IEC 60601-1-11 
Integration 
with 
home activities 
Device is large enough to facilitate a 
variety of activities. 
Dimensions: 
Height: 66 cm to 130 cm 
Width: 67 cm to 104 cm 
Length: 48 cm to 84 cm 
 
Device is able to bear a variety of 
loads throughout use. 
Device can function with 0–50 kg load at center 
of tabletop during excursion. 
Low noise level 
Sound produced by device is not 
distracting in home setting. 
< 35 dB directly above device surface. 
Long 
duration 
continuous use 
Device cycle time > 4 hours. 
No overheating (>60°C) or stress beyond 50% 
of functioning capacity. 
 
 
Human User Acceptance Sub-Study #1 
 
Aim: The main aim of the PwP user acceptance study is to identify an average of 80% acceptability of a number 
of specific MRSSD settings and user response derived from 18 PwP across a range of imbalance, slow gait, 
cognitive impairment, physical frailty, fear of falling and medical comorbidities (metabolic changes, DM, or age-
associated vestibular changes. This will enable identification of MRSSD settings that are feasible for the majority 
of PwP. However, these settings can be adjusted up or downward when mandated by the subject's specific 
condition and individualized therapy goals. The functional use and duration of utilization of the MRSSD will be 
assessed in a laboratory-based environment at the University of Michigan by on-site interaction with the STTR 
team. This will allow for close monitoring of safe use of the MRSSD, avoid estimated time-of-use bias when 
relying on self-reporting in the home environment, and discuss immediate user feedback that will inform the 
development of a monitoring and biofeedback driven interface device in Phase II of this STTR.  
 
Study entry screening session: University of Michigan Institution Review Board (IRBMED) approved written 
informed consent will be obtained from each subject prior to any research procedures. After consenting, 
participants will complete a screening and neurological examination using the UK diagnostic UK Parkinson's 
Disease Society Brain Bank Research Center (UKPDSBRC) criteria (44) with evidence of at least one of the 
following PIGD motor features (slow gait, imbalance, falls, freezing of gait) and/or MCI (21). Medical 
comorbidities of metabolic changes, DM, frailty/sarcopenia or age-associated vestibular changes are allowed 
(22-24). PwP with dementia will be excluded (49). More and detailed exclusion criteria are provided in 
(“Protection of Human Subjects). Males and females will be studied as equally as possible, though more men 
are diagnosed with Parkinson’s than females by a ratio of 2:1 (78) (Biological variables, NIH Rigor statement). 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
Subjects will also complete the Montreal Cognitive Assessment Scale which will serve as a measure of general 
cognitive status (75).  
 
Participants will have 2 study visits about a week apart with goal of shown ability to operative and use the desk 
for a minimum of 1 hour at the time of the 2nd visit. We will use the User Acceptance Study Questionnaire  and 
SUS instrument on each day. Responses on the 2nd day after 1 hour of use will serve as the main primary 
acceptance outcome. An activity monitor (ActivPAL) will be worn during each of the sessions to measure overall 
movement. Total movement for each session will be defined as the number of ‘counts’ per minute – a unit of 
activity measurements that is the result of summing post-filtered accelerometer values into epochs (i.e., the 
higher the number of counts, the greater the amount of activity). We will obtain additional measures to determine 
optimal directionality, including the extent of musculoskeletal muscle fatigue using visual analogue scales and 
user feedback on preferred directional movements (7). Optional measurements of weight, height, pulse and blood 
pressure, feet and ankle measurements may be taken. We will also use a System Usability Scale (SUS) at each study 
visit.  
 
Human User Acceptance Sub-study #2 
 
Aims: 
In-lab supervised feasibility study of repeated standing MRSSD sessions in PwP (n=8) after initial user 
acceptance study to assess: 
(i) multi-session safety and tolerance of 2 hr/d for 5d/2 wks of MRSSD use, 
(ii) successful ability of cognitive/motor dual-task desktop activities, 
(iii) sensitivity of the proposed outcome parameters to be used in the in-home clinical trial & 
(iv) to directly allow the investigators to observe how participants learn the interact with the desk across multiple 
sessions. 
 
Study entry screening session: University of Michigan Institutional Review Board (IRBMED) approved written 
informed consent will be obtained from each subject prior to any research procedures. After consenting, 
participants will complete a screening and neurological examination using the UK diagnostic UK Parkinson's 
Disease Society Brain Bank Research Center (UKPDSBRC) criteria (44) with evidence of at least one of the 
following PIGD motor features (slow gait, imbalance, falls, freezing of gait) and/or MCI (21). Medical 
comorbidities of metabolic changes, DM, frailty/sarcopenia or age-associated vestibular changes are allowed 
(22-24). PwP with dementia will be excluded (49). More and detailed exclusion criteria are provided in 
(“Protection of Human Subjects). Males and females will be studied as equally as possible, though more men 
are diagnosed with Parkinson’s than females by a ratio of 2:1 (78) (Biological variables, NIH Rigor statement). 
Subjects will also complete the Montreal Cognitive Assessment Scale which will serve as a measure of general 
cognitive status (75). 
 
In-lab supervised feasibility study of repeated MRSSD standing sessions in PwP: 
All subjects will complete a baseline clinical test battery and assessment of 3-day physical activity prior to 
the 2-week in-lab supervised feasibility study of repeated MRSSD standing sessions in PwP. The clinical test 
battery and assessment of 3-day physical activity will be completed after the 2-week intervention study (see 
Table 1 below). Optional measurements of weight, height, pulse and blood pressure, feet and ankle 
measurements may be taken. Additionally, optional measures of grip strength with a handheld dynamometer 
and optional measures of trunk strength with a lateral plank may be completed (79). Optionally, a microFET3 
handheld dynamometer will be used to assess hip abduction strength (80). 
 
Table 1: Clinical test battery measures pre/post the 2-week intervention: 
 
 
Outcome measures 
Tests 
Function 
Validity 
Primary motor: 
Timed Up and Go 
(TUG) test  (26) and 
Integrated postural 
control & gait measure 
Mobility 
measure; 
Predictor of falls 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
Romberg Balance Test 
(81) 
with 
instrumented 
sensor 
assessment 
(iTUG, 
Mobility 
Lab, 
APDM, 
Inc., 
Portland, 
OR); figure 2. 
Primary cognitive-motor 
dual task: 
Stroop 
Color 
Word 
stepping test (27); figure 3. 
Complex 
stepping 
test requiring inhibitory 
control 
Fall risk: Predictor 
anticipation of and/or in 
response 
to 
environmental hazards  
Primary cognitive: 
Stroop 
Color 
Word 
Interference test (28, 29) 
Interference 
susceptibility (inhibitory 
control) 
Executive 
function 
measure (cognition) 
Exploratory 
motor 
(muscle 
strength/frailty/sarcopenia):: 
Muscle strength hip 
abductors 
& 
adductors 
(microFET3 
handheld 
dynamometer, (optional) 
(80)); grip strength with 
handheld 
dynamometer 
(optional), 
hip/oblique 
strength with timed lateral 
plank (optional) (79) 
 
Quantitative muscle 
strength 
mediolateral 
leg 
adductors 
& 
abductors  
 
Predictor of falls, 
postural stability (30) & 
proxy 
measures 
of 
frailty 
Exploratory cognitive: 
WAIS-III: 
Digit 
Symbol-Coding 
(31), 
Delis-Kaplan Trail Making 
Test (32), Eriksen Flanker 
test (33) 
 
Information 
processing 
speed, 
concept 
shifting 
& 
visual attention 
Daily 
functional 
performance; fall risk 
Exploratory 
cognitive-
motor dual task(s) 
Clinical reaction time 
grasping 
falling 
computerized stick (34, 
35) 
Cognitive-motor 
response inhibition  
Predictor of falls 
Exploratory measures: 
Actigraphy 
(activPAL, Glasgow, 
UK) 
Carry-over 
effects 
of desk use on daily 
physical activity  
Physical 
activity 
(inversely correlated to 
fear of falling) 
Exploratory measures: 
Continuous glucose 
monitoring 
(Dexcom G6 Pro, San 
Diego, CA) 
Average 
glucose 
level 
Metabolic 
parameter 
Exploratory measures: 
VO2 
energy 
expenditure 
(Cosmed 
K4b2 
gas 
analyzer 
Cosmed, Rome, Italy). 
VO2 
Energy expenditure 
measure 
Exploratory measures: 
Time behind table 
Desk utilization 
Adherence 
to 
intervention 
 
In-lab intervention: There will be 5 sessions (2 hr per sessions; 5 sessions in a two week period) of in-lab 
supervised feasibility study of repeated MRSSD standing sessions in PwP 
 
Subjects will be asked to use the standup desk ad libitum with the choice to alternate between sitting down 
and standing if desired or needed. Subjects will be able to choose the directionality of the desk (mediolateral, 
anteroposterior or oblique) and adjust the speed and amplitude as per instructions. A set of specific instructions 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
that will be given to our participants: "You will be asked to stand behind the raised table until you develop 
discomfort, such as back or leg pain for which you normally would sit down. At that point, you will lower the table 
and remain seated until the discomfort has resolved and you feel you are able to stand again ". 
Subjects will stand on an anti-fatigue mat. Subjects will be asked to perform all the office routines behind the 
stand-up desk as they normally would. Except when completing specific assessment tests, subjects can perform 
their preferred desktop activities, including use of computer, games, videos/movies, listening to music or reading. 
Specific elected activities will be tracked.  The total time spent in upright standing compared to sitting will be 
tracked. Total time to take breaks will be recorded. Each session will not exceed 2 hours. As many rest breaks 
will be provided to the subject as needed. Participants will be supervised by trained research staff under the 
supervision of a physical therapist. (see below). User Acceptance Study Questionnaire and SUS instrument will 
be administered during the visits. Optional instrumented ADPM sensors (Mobility Lab, APDM, Inc., Portland, 
OR) can be used during the standing sessions to track movement and center of mass (76).  
 
Individualized interventions. The study PT will provide individualized targeting of specific morbidities in PwP, 
such as imbalance (emphasis on mediolateral excursions), gait turning (emphasis on rotatory excursions), 
metabolic syndrome and sarcopenia (emphasis on higher intensity and large excursions), vestibular changes 
(emphasis on anterior-posterior and rotatory excursions), and cognitive impairment (emphasis on cognitive-
motor dual tasking desktop activities).  
 
The following assessment swill be made during the 2-week trial: 
• 
Cumulative number of adverse events as categorized by the University of Michigan IRBMED 
classification (mild, moderate, severe; related/unrelated) 
• 
Daily and cumulative musculoskeletal discomfort  
• 
Percentage of participants able to complete specific cognitive desktop activity (reading task, typing 
performance, web search task). 
 
Physical therapy instructions: Physical activity studies have shown that individualized instructions and 
supervision during a study are of paramount importance. Instructions on proper body positioning at the table, 
individual adjustment of table height, proper positioning of upper extremities, use of anti-fatigue mat, and 
optimal monitor height will be performed by  trained research staff under the supervision of a physical 
therapist.. They will also monitor the subject and provide feedback about best standing practices, including 
pelvis and lumbar spine positions. Additionally, they will monitor each subject throughout the study and will 
guide the mobility assessments in this study. 
 
Sub-study #3: Randomized controlled and examiner-blinded MRSSD vs. regular static standing desk vs. 
non-desk control group in a 12-week in-home pilot clinical trial in PwP 
 
Aim: The main aim of the pilot randomized controlled clinical trials is to collect preliminary motor and cognitive 
effectiveness data in a randomized controlled and examiner-blinded MRSSD vs. regular static standing desk vs. 
usual care non-desk control group (n=6 per group; to account for attrition, n=25) in a 12-week in-home pilot 
clinical trial in PwP. We hypothesize that PwP in the MRSSD group will have better motor and cognitive-motor 
dual task performance compared to the static standing desk and usual control group. To accommodate 
participants’ schedules, the in-home portion of the study will be 12 weeks plus or minus one week. This will allow 
for some flexibility if participants are out of town or unable to schedule their post-intervention visit at exactly 12 
weeks.  
 
Study entry screening session: University of Michigan Institutional Review Board (IRBMED) approved written 
informed consent will be obtained from each subject prior to any research procedures. After consenting, 
participants will complete a screening and neurological examination using the UK diagnostic UK Parkinson's 
Disease Society Brain Bank Research Center (UKPDSBRC) criteria (44) with evidence of at least one of the 
following PIGD motor features (slow gait, imbalance, falls, freezing of gait) and/or MCI (21). Medical 
comorbidities of metabolic changes, DM, frailty/sarcopenia or age-associated vestibular changes are allowed 
(22-24). PwP with dementia will be excluded (49). More and detailed exclusion criteria are provided in 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
(“Protection of Human Subjects). Males and females will be studied as equally as possible, though more men 
are diagnosed with Parkinson’s than females by a ratio of 2:1 (78) (Biological variables, NIH Rigor statement). 
Subjects will also complete the Montreal Cognitive Assessment Scale which will serve as a measure of general 
cognitive status (75). 
 
 
Design: Randomized, controlled examiner-blinded clinical pilot trial. 
 
All subjects will complete a baseline clinical test battery and assessment of 3-day physical activity prior to the 
12-week in-home use of the MRSSD vs. static standing desk vs. usual care control group. The clinical trial design 
and details are shown in figure 2 below. For participants who received a desk, they will have the option to 
participate in an open label extension of using the table. Participants can decide if they would like to keep the 
desk in their home for an additional 1-2 years. During this time, they will have the option to provide user feedback. 
This will enable participants who feel they are receiving a personal benefit of being more active to continue to 
use the device. The study team may ask participants about discomfort they experience while using the device 
and ease of use.  
 
A clinical test battery and actigraphy will be administered prior to (V1) and at the end (V2) of the 12-week (plus 
or minus 1 week) intervention period (V1= visit 1; V2 = visit 2). Study randomization will be semi-random based 
on age (±7 yr) and the number of males and females will be matched in each group. 
 
Figure 2: Outline of in-home randomized controlled clinical pilot trial of MRSSD vs. static standing desk use vs. 
usal care control group (all three having a weekly exercise group) in 18 PwP (n=6 per group). Trained research 
staff under the supervision of a physical therapist will make biweekly (i.e. every other week) phone calls during 
the study to provide monitoring of the participants and identify and remedy any issues that may occur. If 
participants do not answer phone call on specified date or establish that they prefer emailing to calling, the study 
team may email the participant to satisfy the monitoring requirements. These monitoring calls/emails will occur 
every two weeks plus or minus 3 days.  
 
 
 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
In-home therapy table/standing desk instructions: As in-home therapy desk use will be unsupervised, trained 
research staff under the supervision of a physical therapist will perform an initial in-home safety assessment to 
ensure safety of the dynamic stepping desk set-up. The table cut-out side will be situated to optimize safety 
(based on PT and research staff judgement). Instructions on proper body positioning at the table, individual 
adjustment of table height, proper positioning of upper extremities, use of anti-fatigue mat, and optimal monitor 
height (if using a PC) will be given. The table also as a ‘red button’ emergency stop button. The tabletops have 
a cut-out that partially encircles the user. This construction will provide a gentle tactile cue to move and take a 
step and at the same time provide safety given the partial surround. OHSU “neutral body positioning” guidelines 
will be explained to the participant. The therapist will instruct the subjects to use the table for an average of 2 
hours per day for at least 5 days per week. The therapist will review with the subject a wide range of computer 
and non-computer desktop activities and advise on properly performing these tasks on the desk. The therapist 
will instruct in proper use and adjustment of the table and of the table-use monitoring system. Unlike typical more 
rigid standing instructions for a static standing desk more frequent stepping and postural adjustments are 
encouraged for users of the dynamic stepping desk, including transient leaning if desired. 
 
Individualized interventions in PwP with PGD motor features, MCI, frailty and associated common medical 
comorbidities (metabolic changes, DM, frailty/sarcopenia or age-associated vestibular changes). Based on the 
V1 assessment the study PT will prescribe individualized targeting of specific morbidities in PwP, such as 
imbalance (emphasis on mediolateral excursions), gait turning (emphasis on rotatory excursions), metabolic 
syndrome and sarcopenia (emphasis on higher intensity and large excursions), vestibular changes (emphasis 
on anterior-posterior and rotatory excursions), and cognitive impairment (emphasis on cognitive-motor dual 
tasking desktop activities). These settings will be practiced during initial 1-2 supervision sessions (in-home, in-
lab). These practice sessions will apply to participants in groups A & B. 
 
Outcome measures & scientific rigor: The scientific rigor of our proposal is strengthened by the high 
reproducibility and clinical relevance of our primary outcome measure, the randomized trial design of the study, 
and blinding of examiners who administer the clinical test battery but are not part of the daily operations of the 
study. 
 
Primary outcome measures: Timed Up and Go (TUG) Test. The primary outcome measure will be the TUG 
test (total time) (26). The TUG is the most frequently used test to assess functional mobility (36). Functional 
mobility is a person's ability to move to accomplish activities of daily living; it bridges the concepts of mobility and 
functional ability. Functional mobility is commonly lost in PD. The TUG has also been shown to have good 
prediction to distinguish elderly fallers from non-fallers (37). Stroop Color Word Stepping Test, a cognitive motor 
dual-task requiring inhibitory control, is a prime example of an attention and cognitive processing-dependent 
motor stepping test where PwP perform less well compared to healthy control persons (38). Impaired inhibitory 
control contributes to stepping errors, impairs gait adaptability and may increase fall risk in people with PD (39). 
Optional measurements of weight, height, pulse and blood pressure, feet and ankle measurements may be 
taken.  
 
Regarding exploratory measures, an optional vertical jump test may be performed to measure power, only 
after a bone density scan is performed or a trained clinician evaluates the subject for any evidence of bone 
weakness (77). APDM sensors would be used during the administration of this test to track the position of 
different joints. Additionally, optional measures of grip strength with a handheld dynamometer and optional 
measures of hip and oblique strength with a lateral plank may be completed (79). Optionally, a microFET3 
handheld dynamometer will be used to assess hip abduction strength (80). 
 
 
Exploratory outcome measures are listed in table 2 below: 
Table 2: Pilot clinical trial outcome measures 
Outcome measures 
Tests 
Function 
Validity 
Primary motor: 
Motor 
assessment, 
MiniBest (55), Timed Up 
Integrated postural 
control & gait measure 
Mobility 
measure; 
Predictor of falls 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
and Go (TUG) test  (26) 
ISAW and ISWAY (56-58) 
with instrumented sensor 
assessment 
(iTUG, 
Mobility Lab, APDM, Inc., 
Portland, OR); figure 2. 
MDS-UPDRS examination 
(parts 
1-4) 
(67-68), 
Modified H&Y (69-72) 
 
Primary 
cognitive-
motor dual task: 
Stroop 
Color 
Word 
stepping test (27); figure 3. 
Complex 
stepping 
test requiring inhibitory 
control 
Fall risk: Predictor 
anticipation of and/or in 
response 
to 
environmental hazards  
Primary cognitive: 
Stroop 
Color 
Word 
Interference test (28, 29) 
Interference 
susceptibility (inhibitory 
control) 
Executive 
function 
measure (cognition) 
Exploratory 
motor 
(muscle 
strength/frailty/sarcopenia): 
Muscle strength hip 
abductors 
& 
adductors 
(microFET3 
handheld 
dynamometer, 
(optional) 
(80)); 
Whole body DXA scan 
(Hologic); Vertical Jump 
Test (optional) (77), grip 
strength 
with 
handheld 
dynamometer 
(optional), 
hip/oblique strength with 
timed 
lateral 
plank 
(optional) (79).  
 
Quantitative muscle 
strength 
mediolateral 
leg 
adductors 
& 
abductors & 
lean muscular mass 
lower body 
Predictor 
of 
falls, 
postural stability (30) &  
Proxy measures of 
frailty 
Exploratory cognitive: 
WAIS-III: Digit Symbol-
Coding (31), Delis-Kaplan 
Trail Making Test (32), 
Eriksen Flanker test (33) 
Information 
processing 
speed, 
concept shifting & visual 
attention 
Daily 
functional 
performance; fall risk 
Exploratory 
cognitive-
motor dual task(s) 
Clinical reaction time 
grasping 
falling 
computerized stick (34, 
35) 
Cognitive-motor 
response inhibition  
Predictor of falls 
Exploratory 
Questionaries 
Fatigue Severity Scale 
(62), 
Activity 
Questionnaire (73), Short 
Falls Efficacy Scale (65), 
The 
Short 
Activities-
specific 
Balance 
Confidence 
Scale 
(64), 
PDQ39 (61), Mayo Sleep 
Questionnaire 
(60), 
Epworth (59),  Insomnia 
Severity 
Index 
(63), 
Instruments of Daily Living 
(66), 
Modified 
Numeric 
Rating Scale( 74), and 
Neurobehavioral 
assessment 
Quality of Life,  
Sleep energy benefit 
ADL 
Pain level 
 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
User Acceptance Study 
Questionnaire (53)  and 
SUS 
instrument 
scales 
(54) 
  
Exploratory measures: 
Actigraphy 
(activPAL, Glasgow, UK 
or Actigraph by ActiLife) 
Carry-over 
effects 
of desk use on daily 
physical activity  
Physical 
activity 
(inversely correlated to 
fear of falling) 
Exploratory measures: 
Continuous 
glucose 
monitoring 
(Dexcom G6 Pro, San 
Diego, CA) 
Average glucose level 
Metabolic parameter 
Exploratory measures: 
VO2 energy expenditure 
the 
(Cosmed 
K4b2 
gas 
analyzer 
Cosmed, 
Rome, 
Italy). 
VO2 
Energy 
expenditure 
measure 
Exploratory measures: 
Time behind table 
Desk utilization 
Adherence 
to 
intervention 
 
Figure 2: APDM Mobility Lab iTUG: design of test & 
placement of Opal sensors (iTUG, Mobility Lab, APDM, Inc., 
Portland, OR) 
Figure 3: Stroop stepping test Participants 
step according to the word and not the arrow 
orientation, incongruent stimulus (27) 
 
Actigraphy: Subjects will first wear a physical activity monitor (activPAL; PAL Technologies Ltd, Glasgow, 
United Kingdom or Actigraph by ActiLife) for 3 days for overall physical activity monitoring. The 3-day physical 
activity monitoring and the clinical testing will be repeated immediately following the completion of the 12 week 
in-home clinical trial (see also Figure 1). This monitoring period will be for a minimum of 3 days, however, if 
there is a scheduling conflict (i.e. holiday, inclement weather), the monitoring period may need to be extended. 
The visits will be scheduled for the next possible business day.  
 
Potential pitfalls and alternative strategies:  
 
Tolerability and safety of MRSSD in target population of PwP. We have designed the human user acceptance 
study such that we will set the primary MRSSD utility functions (range and speed of directional movements, 
ability to write/type or read on moving desktop, and absence of subjective head sensation of dizziness/headache 
and musculoskeletal discomfort) to be acceptable in at least 80% of the target population while using the desk 
for a minimum of 1 hour. Although this may result in initial lower range or slower speed settings we anticipate 
that with continued use settings can be adjusted while having therapeutic gains.  
The project also includes an  in-lab supervised feasibility study (see sub-study #2) of repeated standing sessions 
in PwP (n=6) after initial user acceptance study to assess (i) safety and tolerance of 2 hr/d for 5d/ 2 wks of 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
MRSSD use, (ii) successful ability to cognitive/motor dual-task desktop activities; (iii) sensitivity of the proposed 
outcome parameters before starting this pilot RCT in-home clinical trial and (iv) to directly allow the investigators 
to observe how participants learn the interact with the desk. 
 
 
Division of work: The technical development (hardware and electrical engineering) of the MRSSD will take 
place at Tulip Make Me Move Desk, LLC and will be performed by the Principal Engineer, Mr. Warren VanHout, 
BSEE, RN. The user acceptance testing will take place at the University of Michigan’s Functional Neuroimaging, 
Cognitive & Mobility laboratory under supervision of Dr. Richardson. 
 
Timeline: The timeline of the study is shown in the table below. 
Timeline 
Mo 1 
Mo 2-3 
Mo 4-11 
Mo 12 
Building initial MRSSD test prototype 
X 
 
 
 
IRB approval, subject recruitment 
X 
 
 
 
User feedback and acceptance study (study 1) 
 
X 
 
 
Supervised in-lab safety and tolerance study (study 2) 
 
X 
X 
 
MRSSD design & user interface adjustments (study 3)  
X 
X 
X 
In-home pilot clinical trial 
 
 
X 
 
Statistical analysis 
 
X (study 1) 
X (study 2) 
X (study 
3_ 
The following milestones need to be achieved: (i) build an MRSSD prototype using cost-effective components, 
including low noise level and rotational motors (company task), month 1. Initial prototype device completion, 
testing are scheduled to be complete within 120 days (end of month 3); (ii) University of Michigan IRB approval 
for MRSSD human user studies (academic partner tasks, month 1); (iii) user acceptance study showing proof of 
principle that 80% or more of older adults with PwP (including those who are more frail or have cognitive 
complaints) can independently operate the MRSSD and are able to stand behind the desk for at least 1-2 hour(s), 
months 2-3;  completion of in-lab sub-study  by 6-months.  Benchmark of success: completed testing of 9 
subjects by end of month 2; (iv) complete randomized controlled clinical pilot trial (study 3) during months 4-11;  
benchmark of success: completed testing of 8 subjects prior to month 8; (v) statistical analysis and final MRSSD 
design upgrades (month 12). If these milestone criteria are met, we will consider the novel MRSSD prototype 
suitable for further development and the company will apply for Phase II funding. Based on movement 
biofeedback that will be collected during testing we will also create a concept design for the interface device.  
 
Potential pitfalls and alternative strategies: The most significant problem that may arise is the inability to meet 
the design specifications as laid out in Table 1. The proposed design concept (Figure 4) is the lead design based 
on preliminary design feasibility research by our engineer. The engineering challenges associated with the 
MRSSD arise from the requirement to make noise, vibration and surface movement 'insensible' to the desktop 
user (at least at default speed of 3 mm/sec). Therefore, the single most important cost-effective component is to 
have a low-cost drive system that also meets a low noise level requirement (<35 dB directly above device 
surface). Alternative activity-surface suspensions, drive systems, controllers and noise/vibration management 
and suppression techniques are under evaluation. Alternative designs (e.g., hydraulics) and alternative power 
sources of non-linear actuation, will be further developed, if needed.  
 
Attrition: Our net recruitment goals for the user acceptance study will be 18 PwP and 18 for the pilot clinical trial 
(6 per group). Our recruitment goals for the repeated standing study will be 8 PwP. Due to possible diagnostic 
screen failures and attrition we will recruit up to a maximum of 40 participants for the whole phase I project. 
 
Adherence with actigraphy use: We have preliminary data from our pilot studies showing that PD patients have 
100% compliance without missing data with a 3-day actigraphy protocol at home. The ActivPal is adherent to 
the thigh and can be worn 24 hours/day and is more convenient than typical actigraphy. The actigraph can 
adhere to clothing and can be worn 24 hours/day. Participants will also use daily logs to track usage.  
 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
Variations in time-behind-table utilization: Our Parkinson study data showed that patients were able to use the 
dynamic standing desk for an average 2.2±0.4 hours per day for at least five days per week without a drop in 
daily use in the later stages of the trial (excellent sustained 4-mo adherence rate). It is possible that some 
participants may deviate from this average. Therefore, we will tract the time behind the table use in upright as 
well as sitting mode and use this as a covariate in the analysis in a sensitivity analysis (see also section on 
compliance and monitoring of table use below). 
 
Compliance and monitoring of table use ('time-behind-table'): To monitor compliance with the dynamic standing 
table protocol video surveillance will be performed as developed by our collaborator Lauro Ojeda (82). A frame 
will be recorded during the waking times when the participant stands in front of the desk. This camera is motion 
activated and will record 60 second clips. This technique will provide information regarding protocol compliance, 
but also provide table use durations. Since only the participant is permitted to use the desk in the dynamic setting 
during the in-home portion of the table, this will also allow us to distinguish between anyone who may be using 
the desk in the static setting (i.e. spouse, other family members).  
Adherence with actigraphy use in the PD patients: We have preliminary data from our pilot studies that PD 
patients (n=4) have 100% compliance without missing data with a 3-day actigraphy protocol at home. The 
ActivPal is adherent to the thigh and can be worn 24 hours and is more convenient than typical actigraphy. 
 
Tolerability of MRSSD in target population of older adults with PwP. We have designed the human user 
acceptance study in such a way that the default MRSSD utility settings and functions (range and speed of 
directional movements, ability to write/type or read on moving desktop, and tolerance of musculoskeletal 
discomfort to be acceptable in at least 80% of the PwP target population while using the desk for a minimum of 
1 hour. Although this may result in initial lower displacement range or slower speed settings we anticipate that 
with continued use settings will be adjusted upward due to therapeutic gains. Furthermore, a more simple 
dynamic stepping desk desk model was very well tolerated in PwP.   
 
In-home safety of MRSSD: There were no serious adverse events or falls during desk use in our 4-month in-
home study using the dynamic stepping desk prototype in PwP. However, safety measures will be in place, using 
a desk cut-out wherein the participant can stand and can hold on to the desk when needed, a ‘red’ button alarm 
stop button, handles to each side of the desk cut-out, positioning of the MRSSD close to the wall and individual-
specific RFID on/off control (RFID control worn at the user’s wrist with deactivation when stepping away from 
desk). 
 
Assessment of use over 4 months may not accurately represent long-term user acceptance but will be further 
evaluated in Phase II of this application (see below). We also anticipate that a user feedback system will increase 
long-term adherence. 
 
Plans for Phase II: If milestones for Phase I have been met, we plan to submit a proposal for Phase II funding 
with the focus in Phase II on two major goals. The first aim for Phase II is to perform a large scale randomized 
controlled clinical trial to assess the clinical mobility (including fall risk), cognitive-motor dual-tasking, functional 
ability, quality of life effects and long-term utilization of MRSSD use in older adults with PwP. The larger number 
of participants in this phase II clinical trial will allow sensitivity analyses to assess relative effectiveness of the 
MRSSD on the major clinical components of the PwP syndrome: slow walking, balance, cognition, fall risk, and 
frailty and to assess differential mechanistic effects of directional use, range and speed of excursion, type of 
(cognitive) desktop activity. For example, mediolateral excursion may strengthen hip abductors and adductor 
important for dynamic balance, rotatory movements for fall risk reduction, higher intensity settings for frailty and 
more engaging cognitive desktop activities for cognitive impairment. The second aim is to optimize a monitoring 
and feedback-driven human interface device to control the MRSSD that is optimized for the PwP target 
population. Example of basic specifications are listed in Table 2. We will also further develop the product to meet 
commercial and marketable preferences such as affordability ($2000 for device, comparable to Medicare cap for 
PT), device reliability, and an aesthetically pleasing device.  
Table 2. Overview of critical user needs, requirements, and specification for MRSSD feedback-driven human 
interface device during Phase 1. 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
User Need 
Requirement 
Specification 
Ease of use 
Simple user interface 
• 
< 20 minutes to learn 
• 
Large interface buttons 
User interface is reachable by person with 
decreased mobility 
User interface < 90 cm from user’s shoulder 
when standing at center of tabletop. 
Personalizable Speed can be varied 
1 to 5 mm/sec 
Excursion distance can be varied 
25 cm to 1 m. 
 
Subject Compensation: 
The subjects will receive $50 per clinical assessment and screening session completed and $10 per physical 
therapy and exercise session attended. The maximum total for sub-study 1 (screening visit, 2 standing session), 
sub-study 2 (7 visits), and sub-study 3 (2 visits, 12 exercise classes) would be up to $720. Subjects will be paid 
after their last study visit or, in case they decide to withdraw from the study, they will be paid for the portions that 
they have completed. Since each sub-study consists of a separate consent, subjects will be paid after their last 
study visit for a given sub-study.  
 
Overnight accommodations may be provided depending on personal circumstances or if you live far away. We 
will discuss with you the need for these accommodations as the research appointment(s) are being arranged. If 
eligible, overnight lodging can be arranged through the UMHS Patient and Visitor Accommodations Program 
either by a study team member or by you. However, you may decide to make alternative arrangements. In that 
case, please discuss with the study team first if you are eligible for reimbursement prior to making any 
reservations. We can only reimburse for expenses that have been approved in advance by the study team. You 
will need to provide receipts to the study team before expenses can be reimbursed. We will reimburse to a 
maximum of $200 for lodging. You will receive a voucher for valet parking at the University Hospital. Parking at 
Domino's Farms is free. 
 
Transportation: Recognizing that some interested individuals may lack reliable means of transportation, we have 
developed detailed transportation protocols that include using UM fleet vehicles and UM shuttle services as well 
as low- or no-cost cabs and shuttles available to seniors in the counties immediately surrounding Ann Arbor. We 
have developed a sound transportation plan and have budgeted a travel allowance for participants who require 
transportation or lodging services. 
 
Data Analysis/Interpretation: 
Statistical analysis: The user acceptance study will consist of open-label assessment and reporting of success 
rates of independent completion of the acceptance criteria for a minimum 1-hr desk utilization target time on the 
2nd day of acceptance testing in ≥ 80% of PwP subjects (study 1). For study 2 ratings of adverse events, 
discomfort, and percentage of participants able to complete cognitive desktop activity (reading task, typing 
performance, web search task), 5-session sustained acceptance testing in n ≥ 80% of PwP subjects, and to 
assess sensitivity of change of proposed outcome parameters for the subsequent in-home clinical trial. For study 
3, ANOVA/mixed linear modeling will be used to determine if the change in the main outcome parameters 
between pre- and post-trial performance is different between the three groups.  The effects of gender and age 
will be included as an important biological variable in both analyses. 
 
 
Potential Risks 
 
Confidentiality of Research Information: The research data to be collected from subjects will consist of 
confidential clinical screening information and behavioral observation data relating to musculoskeletal 
discomfort. These research data are not intended for entry into subjects’ clinical medical records. However, the 
data remain potentially discoverable. This may lead to violation of privacy and embarrassment of the subject. 
We will employ stringent safeguards against unintended and inappropriate discovery and dissemination of 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
personal medical and research data in our subjects by a multilayered approach. All data bearing potential subject 
identifiers will reside solely in locked files in the offices of the study investigator. Original data collection 
documents will be maintained in secure files under the control of the investigators. Entries regarding details of 
the research project and its results will not be submitted to clinical medical databases. Electronic databases in 
the project will employ subject codes that cannot be linked directly to participants without a “key”, possessed 
only by the study investigators in a secure location, and maintained separately from the databases. Databases 
will not be housed on systems with internet access, preventing unauthorized intrusions. Personal information 
that would directly identify study subjects will not be used in any publications or presentations resulting from this 
research study, unless separate written permission is given by the subject (or proxy). Any superfluous records 
will be shredded. 
 
Musculoskeletal discomfort: There is a risk of musculoskeletal discomfort with prolonged standing. The ad libitum 
sit-stand design of the study will allow the subject to sit down at any time. Subjects are also allowed to lean on 
the tabletop if desired. 
 
Standing: Subjects will be standing upright behind a table making small steps. This is not different from normal 
standing conditions that can be encountered during normal daily routines. Nonetheless, there is a rare risk of 
falling, comparable to the risks of everyday life. Subjects will be standing close to a wall and rest breaks will be 
provided when needed. The total duration of up to 4 hours per condition may cause some musculoskeletal 
discomfort. The electronic sensors to measure movement and balance are about the size of a watch and will be 
worn around the ankles and wrists affixed with ankle- and wristbands, or around the waist. Subjects will be 
provided as many rest breaks as needed and they will also stand on anti-fatigue mats. Each condition will be 
performed on a different test day. Subjects will also be advised that they have the option to completely stop 
testing if they feel too uncomfortable. The overall study looks at normal standing and taking small steps and 
sitting, which are all normal activities of daily life. Therefore, the risks are deemed comparable to the risks of 
everyday life. There is also an infrequent risk of lightheadedness, dizziness, a decrease in blood pressure, feeling 
disoriented, or feeling off balance. People with Parkinson’s disease often experience lightheadedness and 
dizziness as a symptom of underlying disease. These risks can be mitigated by sitting down, drinking water, or 
having a snack. Subjects may stop standing if they feel too uncomfortable.  
 
Falling: There is a small risk of falling with the MRSSD use. For this reason, the device will be positioned about 
0.5 meters from a wall ensuring positioning of subjects closely to the wall to minimize this risk. Overall, risk of 
falling is very small as subjects can lean on the table and the table moves very slowly. There were no falls in our 
study of the 14-week post-PT extension of in-home use of dynamic standing desk in patients with Parkinson's 
disease. 
 
Test Anxiety: There is a rare risk that subjects may experience some minor anxiety (‘test anxiety’), become 
worried, or have an anxiety reaction in response to any of the tests and procedures. For example, subjects may 
suddenly experience anxious feelings or become worried about their health. Trained research staff will conduct 
all tests and procedures. The staff will be prepared to respond to anxiety, concerns, and behavioral changes, by 
temporarily suspending testing, breaking up testing or answering questions. 
 
Varices and venous stasis: There is a risk of worsening or developing varices with upright postures. Participants 
will be screened for lower extremity venous stasis and/or excessive varicosis. However, the risk of varicosis is 
greater for static than dynamic standing as the lymphatic pump function of calf musculature is less effective with 
static standing. Subjects with mild varicosis are commended to wear low-pressure support stocks in the range 
of 20-30 mm Hg to reduce the possible risk of varicosis during the study. 
 
Risk of foot swelling: Paul et al. compared foot swelling in users of sit-stand adjustable furniture to non-adjustable 
sitting workstations and actually found significantly less foot swelling in the adjustable stand workstation users 
compared to the sitting condition (40). There is also a reduced risk of deep venous thrombosis with standing 
compared to sitting (41). 
 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
Balance/gait assessments: There is a very rare risk that the sensors to measure overall movement and balance 
gait may become detached and that subjects may trip, or that a subject may trip while walking. The sensors will 
be checked regularly for appropriate attachment quality. Many of the tests are comparable to normal standing 
and walking conditions that you may experience in everyday life. Nonetheless, there is an infrequent risk of falling 
or near-falling during these tests which may result in fall-related injuries. Trained research staff will remain in 
close proximity to you at all times and observe (‘spot’) you to prevent you from falling. 
 
Actigraphy: There is a very rare risk of the movement monitoring device (activPAL or actigraph) detaching, which 
may result in a trip during the at home monitoring of movement. It should be noted that the device only measures 
overall movement. It does not record your geographical location or specific activities that subjects were 
performing, neither can this be derived from the data that is stored in the device. Subjects will receive instruction 
for proper attachment of the activity monitoring device. 
 
Continuous glucose monitoring: The CGM system is FDA approved. The FDA safety information includes the 
following contraindications and potential adverse effects. Contraindications: 1) Sensor and transmitters need to 
be removed before Magnetic Resonance Imaging, Computed Tomography scan, or diathermy treatment. It is 
unlikely that our participants will have to do any of those tests for personal reasons. If so, during the recruitment 
phase we will schedule them to participate in the study during different days than the tests. We will also remind 
the participants regularly about this contraindication. 2) Taking medications with acetaminophen while wearing 
the sensor may falsely raise their glucose readings. This is not a contraindication for our non-diabetic participants 
since it is not critical for them to monitor their glucose levels. However, it can introduce bias in our analysis. We 
will remind them to avoid acetaminophen during the study and use alternative painkillers if needed. The following 
events are possible adverse device effects of inserting a sensor and wearing the adhesive patch: local infection, 
inflammation, pain or discomfort, bleeding at the glucose sensor insertion site, bruising, itching, scarring or skin 
discoloration, hematoma, tape irritation, sensor or needle fracture during insertion, wear or removal. All these 
adverse events are considered minor and easy to resolve. We will train the participants in the insertion of the 
sensors and we will ask the participants to communicate us immediately in the event of any adverse effect.  
 
iv) Adequacy of Protection against Risks: 
Older adults with PwP who are interested to participate in this study will be scheduled for the research 
procedures at which time the nature and risks of the procedures will again be reviewed with the subjects and a 
written informed consent form will be obtained by one of the study investigators. One copy of the signed consent 
form will be given to the subject, one will be placed in the patient’s medical record and a third will be kept in the 
patient’s study binder kept at the patient’s research site. 
 
Confidentiality of research information: We will employ stringent safeguards against unintended and 
inappropriate discovery and dissemination of personal medical and research data in our subjects by a 
multilayered approach. All data bearing potential subject identifiers will reside solely in locked files in the offices 
of the study investigator. Original data collection documents will be maintained in secure files under the control 
of the investigators. Entries regarding details of the research project and its results will not be submitted to clinical 
medical databases. Electronic databases in the project will employ subject codes that cannot be linked directly 
to participants without a 'key', possessed only by the study investigators in a secure location, and maintained 
separately from the databases. Databases will not be housed on systems with internet access, preventing 
unauthorized intrusions. Personal information that would directly identify study subjects will not be used in any 
publications or presentations resulting from this research study, unless separate written permission is given by 
the subject (or proxy). Any superfluous records will be shredded. 
 
Physical discomfort and side effects of standing: Subjects will be advised to return to a seated position if they 
experience physical discomfort from using the stand-up desk. Subject will be standing on anti-fatigue mats to 
prevent musculoskeletal discomfort. Participants will be screened for lower extremity venous stasis and/or 
excessive varicosis. However, the risk of varicosis is greater for static than dynamic standing as the lymphatic 
pump function of calf musculature is less effective with static standing. Subjects with mild varicosis are 
commended to wear low-pressure support stocks in the range of 20-30 mm Hg to reduce the possible risk of 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
varicosis during the study. There is a reduced risk of deep venous thrombosis with standing compared to sitting. 
Subjects will also be advised that they have the option to completely stop the study if they feel too uncomfortable 
with the dynamic standing desk. 
 
Test anxiety: Trained research staff will conduct all tests and procedures. The staff will be prepared to respond 
to anxiety, concerns, and behavioral changes, by temporarily suspending testing, breaking up testing or 
answering questions. 
 
Frailty assessment: A popular approach to the assessment of geriatric frailty encompasses the assessment of 
five dimensions that are hypothesized to reflect systems whose impaired regulation underlies the syndrome. 
These five dimensions are: 
(a) unintentional weight loss, 
(b) exhaustion, 
(c) muscle weakness (using grip strength dynameter), 
(d) slowness while walking, and 
(e) low levels of activity. 
Those who meet at least three of the criteria are defined as frail (42). We will also determine muscle mass 
using a whole body DXA scan to assess for sarcopenia (see below). 
 
Dual-energy X-ray absorptiometry (DXA): A whole body DXA scan will be performed to evaluate total body 
composition, fat content and lean muscular mass (for assessment of frailty). Hip and spine scans will also be 
taken to assess bone mineral density. The DXA scan will be performed on a Discovery-W DXA system (Hologic) 
at the UM Functional Neuroimaging, Cognitive, and Mobility Laboratory. The scan time is approximately six 
minutes for the whole body scan and less than one minute each for the hip and spine scans.  
The biological effect of radiation in humans is measured in terms of Sieverts (Sv) or mSv (1/1000 Sv), which 
is a unit of uniform whole body exposure. Radiation to which a subject will be exposed from this research project 
will be approximately 0.0159 mSv for a DXA scan. The effects on the body of this radiation exposure will be 
added to the subject’s overall lifetime radiation risk. The US Federal Government requires that the annual amount 
of radiation exposure of radiation workers does not exceed 50 mSv per year; the radiation to which the subject 
will be exposed with the DXA scan is less than 0.1% of this amount.  
 
Actigraphy: Subjects will receive instruction for proper attachment of the activPAL or actigraphy device. 
 
Continuous glucose monitor: The continuous glucose monitor can be worn at the lower abdomen. The 
continuous glucose monitor will be inserted using an automatic applicator. The inserted sensor filament will be 
covered by a water-resistant cover what users can take a bath, shower or swim. The sensor is contained in a 
bandaid and can be removed the same way as removing a regular bandaid. 
 
v) Potential Benefits of the Proposed Research to the Subjects and Others:  
PwP may benefit from this repeated session or in-home intervention. Furthermore, in the course of this study 
PwP will receive clinical evaluations including limited clinical, mobility, and cognitive testing. No direct immediate 
benefit of these studies is anticipated. Although generally the results of these examinations will not be made 
available to their treating physician, if a significant, unexpected abnormality is detected this will be reported to 
the patient and his/her physician. 
 
vi) Importance of the knowledge to be gained 
Data obtained from this research will be important for the development of a novel rehabilitation device to 
improve balance, gait, frailty and possibly cognition in older adults with PwP. Positive outcomes in Phase I of 
this study would provide the basis for larger controlled clinical trials of this rehabilitation device in Phase II of the 
STTR. Positive findings in this study may allow expanded indications and research in mobility disorders other 
than PwP. 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
DATA SAFETY MONITORING PLAN 
Drs. Pongmala and Richardson will serve as chairs for the DSMP for this study. They will review outcomes 
with the PI on a semi-annual basis. The DSMP will be asked to review the cumulative safety data up to the 
date identified to make a determination if the study is safe to proceed unchanged or to provide 
recommendations to the sponsor as to how to proceed.  
 
Review of study procedures and adverse effects will be performed on a monthly basis. Drs. Pongmala 
and/or Dr. Richardson be responsible for the day-to-day monitoring any potential breach of confidentiality and 
for reporting any adverse events (AE) following University of Michigan IRB guidelines.  
 
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, 
signs, or symptoms temporally associated with participation in this study, whether or not a causal relationship 
with the study has been established.  
 
Breaches of confidentiality will be considered related to the research whenever they occur and will be 
reported. Withdrawals from the study and the reason for these withdrawals will also be reported. The PI will be 
in daily contact with the PT and study research staff. The research staff will test the participants, score and enter 
the data and will monitor their procedures to ensure that confidentiality is maintained. Research staff will be 
responsible for reporting any significant events to the PI. The PI will ensure that the IRB is notified of any adverse 
event following the IRB guidelines.  
 
Expected and unexpected serious (including fatal) adverse reactions and major unresolved disputes between 
the research investigator(s) and the research participant or between research investigator(s) will be expeditiously 
reported to the IRB of the University of Michigan. At the time of renewal, the IRB will be provided with a summary 
indicating the frequency of the monitoring, cumulative adverse event data, information regarding participant 
safety or ethics changes, confidentiality issues, benefit-to-risk changes and recommendations on continuing, 
changing or terminating the study. 
 
 
 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
RECRUITMENT AND RETENTION PLAN 
Recruitment: PwP subjects will be recruited from the University of Michigan Functional Neuroimaging, Cognitive 
& Mobility Laboratory . Our laboratory also has a high throughput of volunteers for our regular clinical and imaging 
studies and many have provided informed consent to be enrolled for a registry for possible future studies. Our 
laboratory has already collected a waiting list of volunteers who have expressed interest in this or similar studies. 
 
We will leverage a number of resources to ensure we meet (or surpass) our targeted recruitment goals, including 
women and minorities: 
 
i) UM Functional Neuroimaging, Cognitive & Mobility Laboratory: PwP subjects will be recruited from the 
University of Michigan Functional Neuroimaging, Cognitive & Mobility Laboratory. Our laboratory has already 
collected a waiting list of volunteers who have expressed interest in this or similar studies. Our laboratory also 
has a website with our current studies for potential participants to come across.  
 
ii) PMR clinic Dr. Richardson: PwP subjects will also be recruited from Dr. Richardson's busy clinical practice 
in Physical Medicine & Rehabilitation.  
 
iii) Ann Arbor Parkinson's Support Group (PT Miriam van Emde Boas leads a weekly exercise group) will also 
provide recruitment opportunities. 
 
iv) UMHealth Research: UMHealth Research is a free, secure password protected database available to all 
University of Michigan researchers. The study team will access this UM established subject pool. 
 
v) ClinicalTrials.gov Recruitment: Since this project is considered an Applicable Clinical Trial (ACT), the study 
team will be required to post the study on the ClinicalTrials.gov website. This also provide another broad avenue 
for recruitment. 
 
vi) We have prior successful experience with posting radio, TV or newspapers ads, including the Detroit area, 
as an additional strategy to boost recruitment of women or minorities when needed.  
 
Retention: Retention of our study participants is of utmost importance for the successful completion of the 
project. For the human user acceptance study participants will be in daily direct contact with the research team 
for the two testing days. For the pilot clinical trial, our therapist will make biweekly phone calls during the study 
to provide monitoring of the participants and identify and remedy any issues that may discourage continued 
study participation.  
 
RESOURCE SHARING PLAN 
The investigators are committed to resource and data sharing with the clinical research community. Optimally 
effective data sharing is carefully planned. The specific contents and strategy for creating and sharing a public 
use dataset will be established at the beginning of the study, rather than at the end. The primary results of the 
study will be disseminated by publication in the peer reviewed medical literature. In accordance with the NIH 
Public Access Policy, the investigators will submit an electronic version of their final, peer-reviewed manuscripts 
(directly or through the publisher) to the National Library of Medicine’s PubMed Central, no later than 12 months 
after the official date of publication. After completion of the study and dissemination of primary study results, we 
plan to make the data publicly available in accordance with approval and regulations of e policies and guidelines 
established by the NIH with respect to sharing research resources, in particular as laid out in section 8.2.3 
(Sharing Research Resources) of the NIH Grants Policy Statement and the recent new NIA guidance  
https://www.nia.nih.gov/research/grants-funding/nia-specific-funding-policies#datasharing . In accordance with 
these policies, we intend to release and share final research data and materials from NIH-supported studies for 
use by other researchers in a timely manner. 
 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
Subject to UM IRBMED approval, de-identified data will be made available to all requesting investigators with 
the following considerations:  
 
(i) The location of study data repository will be arranged with University of Michigan (UM), e.g. storing it at UM’s 
deep blue repository: https://deepblue.lib.umich.edu/data .  
 
(ii) The timeline of submission of the public use dataset will comply with all relevant repository guidelines but in 
general we plan to submit data to the repository approximately one year after the primary manuscript of the trial 
is accepted for publication. During that year, the investigators will have opportunities to digest the study results 
and generate further hypotheses, and submit manuscript proposals, if so desired. The rationale for the timelines 
is to ensure that there is sufficient time to properly prepare the data, to provide priority to the study investigators 
in manuscript development, but with incentives to do so in an efficient and rapid manner, and to release the data 
to external investigators early. 
 
(iii) Restrictions on sharing:  
* An investigator requesting data must submit a formal written request stating the specific data required and its 
intended scientific use. 
* Upon approval of the request, a data use agreement or material transfer agreement will be created between 
the University of Michigan and the receiving institute. 
* They must agree to refrain from secondary dissemination of the data to other investigators; requests from 
others must be made to this program.  
* All manuscripts, abstracts and press releases using the study data must acknowledge the investigators and 
the study sponsor with the relevant grant numbers. The requesting investigator(s) attest to the scope of their 
intended use of the data, and that they will acknowledge the NIH and this program in the reporting of any results.  
* The investigator may not propose an intended analysis that competes with a stated hypothesis or aim of the 
study until that analysis has been completed and reported in the literature. Thereafter, there will be no restriction 
on the nature of the intended data use, as long as there is a plausible scientific value to the request. 
* No commercial use of the data 
* Only qualified users may access the data,  
* No attempt to reveal personal or private information may be made.  
* Investigators may also set different levels of access, for example, for expert users and novice users. 
 
(iv) Given the involvement of human subjects the following restrictions will apply: 
*The public use dataset will be stripped of any and all personal identifiers and will undergo a de-identification 
process. 
 
 
 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
DISSEMINATION PLAN 
For Phase I direct communication to caregivers, patients and therapists by means of an information session 
on the outcome of this project will be organized in our laboratory. This will provide participants the opportunity to 
be informed about the results of the study, discuss them with the researchers, and have an opportunity to 
participate in the phase II study.  
 
The data will also be output to clinicaltrials.gov for widespread public dissemination. 
 
Phase II study clinical trials findings will be published in peer-reviewed journals and presented at scientific 
meetings. 
 
FDA STATUS 
The study device will be administered under a non-significant risk FDA exempt status and monitored following 
the University of Michigan IRB approval and regulatory process. 
 
INCLUSION OF INDIVIDUALS ACROSS THE LIFESPAN 
No children, young or middle-aged adults will be included in this study. PwP is an age-associated disorder 
of older age starting from middle age and increases with increasing older age. Therefore, the research topic to 
be studied is not relevant to children, young or middle-aged adults. Further development of the MRSSD, 
however, may lead to new indications of MRSSD (or simplified prototypes) use such as possible use in schools 
for children and office workers of any age. 
 
INCLUSION OF WOMEN AND MINORITIES 
Inclusion of Women: Women will be included in this research project and will be given equal priority in 
recruitment as men. The PI will monitor the recruitment of women for this project throughout the study, and 
institute procedures to enhance the enrollment of women, if numbers are not adequate. 
 
Inclusion of Minorities: Enrollment targets of minorities are based on population estimates of the 2010 US 
census for the State of Michigan. Estimates are 14.2% for African Americans, 2.4% for Asian Americans, 0.6% 
for American Indians and Alaska Natives, <0.1% for Native Hawaiians or Pacific Islanders, 1.5% identify by 
another race, and 2.3% identify themselves by two or more races. Minorities will be given equal priority in 
recruitment. The PI will monitor the recruitment of minorities for this project throughout the study, and institute 
procedures to enhance the enrollment of women, if numbers are not adequate. See also the Targeted/Planned 
Enrollment Table. 

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
OVERALL STRUCTURE OF STUDY TEAM 
 
STUDY DESIGN & SETTING 
 
Single site open-label single group intervention trial at the University of Michigan 
 
Administrative sites: University of Michigan 
 
Data coordinating sites: n/a (not a multi-center trial) 
 
Enrollment/participating sites: University of Michigan 
 
Separate laboratory or testing centers: n/a (single site) 
 
 
PERSONNEL (University of Michigan study team) 
 
 
James Richardson, MD, PD/PI: Dr. Richardson is Professor of Physical Medicine & Rehabilitation at the 
University of Michigan. He will be in charge of the scientific aspects of the grant, manage project operations, 
provide regulatory oversight and reporting, and supervise personnel. He will also be the supervisor of the physical 
therapist. Will not be blinded.  
 
Fay Pongmala, PhD., Co-Investigator: Dr. Pongmala wrote her PhD thesis on postural deviations in Parkinson’s 
Disease and is now the lead of the Functional, Neuroimaging, Cognitive and Mobily Lab Kinesiology team. She 
will take on the role of the blinded rater for the participants in the clinical trial portion of this study.   
 
Lauro Ojeda, MSc, Co-investigator: Mr. Ojeda is Associate Research Scientist, Department of Mechanical 
Engineering, University of Michigan. Mr. Ojeda is a mechanical engineer with specialty expertise in the use of 
IMU sensor and signal detection technology. He will analyze the collected sensor data and will assist with the 
processing of the RFID unique desk user data to provide the specific quantitative table use and other mobility 
outcome measures for this study. Will not be blinded. 
 
Miriam van Emde Boas, DPT, Physical Therapist: Miriam van Emde Boas is a Doctor of Physical Therapy and 
will assist Drs. Richardson with the three sub-studies. In particular, she will continuously evaluate subject’s 
physical performance and safety during standing sessions and evaluate for musculoskeletal discomfort. Will not 
be blinded. 
 
Simon David BSc: Mr. David is working on his masters for medical engineering. For this study he will be 
responsible for building and maintaining the study devices. Will not be blinded. 
 
Alexis Griggs BSc: Ms. Griggs is a Lab Specialist Intermediate at the Functional Neuroimaging, Cognitive and 
Mobility Lab. She will assist the physical therapist during sub-study 3 when setting up the study device in 
participant homes. She will coordinate the table deliveries and assist the PT. Will not be blinded.  
 
Abbey Biddix, BSc, Research Technician Associate: Ms. Biddix is a Research Technician Associate at the U of 
M Functional Neuroimaging, Cognitive and Mobility Laboratory. Ms. Biddix will coordinate the study visits, 
perform clinical testing, and obtain informed consent. Since some testing will be done pre and post intervention, 
Ms. Biddix will be blinded to prevent bias.  

Development of a Multifunctional Rehabilitation Standing and Stepping Device for persons with Parkinson’s 
disease 
 
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