Functional Assistance Provided by Myoelectric Elbow-wrist- Hand Orthosis
Phase: NA
Conditions: Paresis, Stroke
Sponsor: Ohio State University

“Functional Assistance provided by Myoelectric Elbow-wrist-hand orthoses" (FAME) 
Myomo FAME Protocol_v.4 
10JUL2017 
1 
SPECIFIC AIMS 
Of the 5.7 million stroke survivors living in the U.S., the majority exhibits significant weakness in 
one upper extremity (UE).1  This devastating impairment undermines performance of valued 
activities and diminishes quality of life.2  Many promising UE rehabilitative strategies have been 
developed, with most emphasizing repetitive, task-specific practice (RTP) incorporating the 
paretic UE. However, most of these regimens3,4,5  are only efficacious in mildly impaired 
individuals; a group comprising only about 20-25% of this population,6  and already exhibiting 
high levels of active, paretic UE movement. 
 
In contrast, survivors exhibiting moderate UE impairment constitute a larger proportion of the 
stroke population,6 yet exhibit little to no active movement in their paretic wrists and fingers and 
limited active proximal movements. These diminished movement capabilities hamper 
participation in UE therapies emphasizing RTP, and responses to conventional rehabilitative 
regimens.3,4,5  Given their relative inability to participate in practice based protocols, device- 
oriented approaches have been explored to facilitate increased movement capability in 
moderately to severely impaired stroke survivors.7 The goal of such approaches is to assist 
clients exhibiting higher UE impairment levels with performing UE movements, with assistance 
from the devices. For example, sophisticated robotic systems have been developed to evaluate 
and treat patients who have sustained strokes.8,9  However, the cost and complexity of these 
systems as well as their size limits their applicability in the clinical and home environments, 
especially with regards to enabling clients to easily perform valued activities. A device that is 
compact, relatively easy to use, capable of capturing the interest of the user, and can be easily 
integrated into valued activities remains an unmet need. 
 
Since the 1950’s, myoelectrically-controlled devices have been integrated into prosthetic limb 
designs,10 and are now considered standard of care for certain patients with disarticulated UEs. 
Developed by Myomo, Inc. (Cambridge, MA), multi-week RTP regimens incorporating a portable, 
myoelectric brace have reduced paretic UE impairment and increased UE function and self-rated 
recovery in stroke survivors with moderate UE deficits.11,12 These braces support the weakened 
or deformed arm while enabling volitional movement of the UE and protecting from joint 
hypermobility. The most recent device version - called the “MyoPro 2 Motion G” - uses 
surface electromyography (EMG) signals from the biceps and triceps brachii and forearm flexor 
and extensor muscle groups to assist the active muscle with movement of the paretic UE. 
Specifically, during active paretic UE movement attempts, the user’s intention to move is 
detected via his/her EMG. The treating therapist can then adjust the system parameters to alter 
the amount of mechanical assistance that the device provides on an as needed basis, using 
software on a tablet or personal computer. 
 
Multi-week RTP regimens incorporating such a device could address an unmet need for an 
efficacious, easily implemented, UE therapy for stroke survivors with moderate UE impairment; 
hundreds of thousands of new patients annually, and millions living in the community. However, 
a paradigm shift in stroke clinical care also requires evidence demonstrating that donning a 

“Functional Assistance provided by Myoelectric Elbow-wrist-hand orthoses" (FAME) 
Myomo FAME Protocol_v.4 
10JUL2017 
2 
MyoPro has an immediate, discernible impact on UE movement and functional limitation, 
especially for patients who may be prescribed such a device with limited opportunities to 
participate in multi-week UE therapy regimens. In pilot work leading to the current study, we 
showed clinically-important increases in UE movement when wearing the MyoPro Moti on 
G(+8.2 points  on the upper extremity Fugl-Meyer scale; a widely used, stroke-specific measure) 
as well as reduced functional limitation and increased gross manual dexterity immediately after 
18 subjects with chronic, stable, moderate UE impairments donned the MyoPro Motion G. As a 
next step, the primary study objective is to compare UE movement while wearing the MyoPro 2 
Motion G versus a resting splint and no device in stroke survivors with moderate UE dysfunction. 
During the study, subjects will undergo general training in the operation of the EMG-controlled 
orthosis and the comparison orthosis, and then guided through a series of standard clinical 
outcome measures. These outcome measures will allow the researchers to directly compare the 
relative benefit of the MyoPro 2 Motion G with a resting hand splint and no device in reducing UE 
impairment and increasing UE dexterity and functional task performance. 
 
Specific Aim 1: Determine the impact of the MyoPro 2 Motion G myoelectric brace on 
affected UE movement. 75 stroke survivors exhibiting moderate UE impairment will be 
administered the UE FM while wearing: (a) the MyoPro 2 Motion-G (b) a comparison resting 
hand splint, and (c) no device, with the order of assessment conditions randomized and 
counterbalanced across subjects. This study design will allow investigators to determine the 
immediate impact of the MyoPro 2 Motion G on increasing UE movement when compared to a 
commonly-prescribed device (resting hand splint) and compared to no device 
 
Based on our supportive pilot data, Aim 1 will test the hypothesis that wearing the MyoPro 
2 Motion-G will result in the largest increases in UE movement compared to the resting hand   
splint and compared to no device as measured by the upper extremity section of the Fugl-Meyer 
Scale (UE FM); our primary outcome measure. While not a functional measure, per se, this 
measure is sensitive to all levels of UE impairment and is, thus, best situated to examine the 
changes in active UE movement likely to occur in the paretic UE that are hypothesized to occur 
most prominently with MyoPro 2 Motion G use. Further, functional outcomes are rigorously 
assessed using the battery of assessments described in Aim 2. 
 
Specific Aim 2: Determine the impact of the MyoPro 2 Motion G myoelectric brace on 
affected UE outcomes. All subjects will undergo a battery of assessments to compare the 
impact on UE outcomes when utilizing the MyoPro 2 Motion G, resting hand splint and no device 
as explained above. Each subject will be administered (a) a battery of functional tasks; (b) the 
Box and Block (B&B) Based on our supportive pilot data, Aim 2 will test the hypothesis that 
wearing the MyoPro 2 Motion G will result in the largest increases in UE outcomes compared to 
the splint and compared to no device. 

“Functional Assistance provided by Myoelectric Elbow-wrist-hand orthoses" (FAME) 
Myomo FAME Protocol_v.4 
10JUL2017 
3
APPROACH 
Subjects 
Subjects will be recruited through local registries at each site. If needed, approved advertisements 
will be distributed to local stroke support groups and outpatient rehabilitation clinics. After being 
identified and signing approved consent forms, subjects will be screened using the following study 
criteria:  Inclusion criteria: (a) MMT >1/5 in the paretic biceps, triceps, finger extensors and finger 
flexors; (b) score > 10 < 30 on the FM AND active shoulder flexion of at least 30 degrees with 
device weight on affected arm; (c) Ability to generate consistent, detectable EMG signal from the 
bicep/tricep upper arm and distal forearm flexor and extensor sensor sites with wrist in neutral, and 
fingers in neutral.  At rest, achieve an EMG of 5 or below on myConfig (wrist and fingers in neutral 
and elbow extended); with gain at < 10 and boost <12, able to reach a threshold of 10 at both bicep 
and wrist flexors/extensors; (d) a single stroke that is the cause of arm impairment, experienced >12 
months ago; if there are additional asymptomatic lesions (as diagnosed by MRI), these subjects may 
also be included. Those with another symptomatic stroke in addition to the stroke causing arm 
impairment are excluded; (e) score >70 on the Modified Mini Mental Status Examination; (f) age 
>18< 85; (g) > 6 months since previous functional or therapeutic use of an upper extremity 
myoelectric orthosis; (h)           Height >5’0”; (i) Weight >110< 250 lbs.; (j) Forearm circumference (at 
widest part) <13 in.; (k) Bicep circumference >9 <15 in.; (l) Upper arm length >5.5 in.; (m) Wrist 
thickness (anterior- posterior) <1.75 in.; (n) ability to stand with minimal assistance Exclusion 
criteria: (a) > 5 on a 0-10 Numeric Pain Rating Scale for pain in the paretic hand, arm or shoulder; 
(b) > 3 on the Modified Ashworth Spasticity Scale in the paretic elbow, >2 at wrist or fingers; (c) < 
2.5 on the Alexander Apraxia scale; (d) history of neurological disorder other than stroke; (e) change 
in anti-spasticity medications in the last 6 months, and/or receipt of botulinum toxin in the paretic UE 
in the previous 4 months; (f) elbow contracture greater than 10 degrees; (g) inability to passively 
extend fingers while wrist is in neutral; (h) other conditions or physical/mental attributes that may 
undermine safety and/or full participation in the study; (i) bilateral hemiparesis. 
 
Apparatus 
MyoPro 2 Motion G Device 
The MyoPro 2 Motion G (Myomo Inc., 
Cambridge, MA, USA) (Figure 1) is a 
custom fabricated limb orthosis that is 
individually fabricated for the patient over 
a positive model of the patient requiring 
education, training, and experience to 
custom-fabricate and fit.  It uses surface 
EMG signals from affected muscle groups 
to control the powered orthosis to assist 
with the movement of a paretic upper 
limb.  
 
 
 
 
 
 
 
 
Figure 1: Myopro 2 Motion G 
The device has been registered with the Food and Drug Administration (FDA) as a powered limb 
orthosis with biofeedback intended for medical purposes that is worn on the upper limb to support, 
to correct, or to prevent deformities or to align body structures for functional improvement.13  The 

“Functional Assistance provided by Myoelectric Elbow-wrist-hand orthoses" (FAME) 
Myomo FAME Protocol_v.4 
10JUL2017 
4
MyoPro 2 Motion G provides powered proportional assistance for elbow flexion and extension and 
gross grasp motions via motors attached to the exterior of the orthosis brace.  It functions by 
continuously monitoring the surface EMG signals of the user’s bicep and tricep muscles for elbow 
motion and the forearm flexor and extensor muscle groups for grasp motion. These signals are 
filtered and processed to provide a desired joint torque proportional to the exerted effort of the 
user. 
 
The signal processing of the measured surface EMG is accomplished through a system that is 
comprised of the MyoPro’s EMG sensors, analog signal–processing components, and digital 
signal–processing components. The signal-processing algorithm enables bidirectional control 
for each joint or degree of freedom through the use of antagonistic EMG signals or unilateral 
active assist combined with a competing passive force for a single EMG signal source. The 
parameters of the device system settings, include gain (amount of assistance provided to the 
user), activation thresholds, and range of motion, can be adjusted for each individual based on 
their level of impairment and physiology through a custom software interface, MyConfig. These 
settings are adjusted by a treating therapist or a Certified Prosthetist and Orthotist (CPO) and 
may require regular updating as the user receives therapy and is trained on operation of the 
MyoPro 2 Motion G. 
 
Comparison Device 
 
 
Outcome Measures 
Figure 2: Comfy Dorsal Hand resting splint 
Outcome measures were chosen to span the International Classification of Function (ICF), as 
well as incorporate reliable and valid measures that are commonly used by rehabilitation 
clinicians. All outcome measures will be administered three times (with the MyoPro 2 Motion G, 
with the resting hand splint and with no device). 
 
Primary Outcome Measure (Aim 1): Like any orthosis, the MyoPro attaches to the affected 
body structure with the goal of supporting the affected arm, facilitating active assisted movement 
of the affected extremity, and, ultimately, facilitating increased participation in valued activities. 
Accordingly, UE movement (orthotic-assisted UE movement when the brace is donned) was 
chosen as the primary construct of interest. Further, due to the more impaired nature of our 
sample, patients would be unsuccessful attempting items on distally-based measures that we 
and others have commonly used in UE trials with minimally-impaired subjects (e.g., Action 
Research Arm Test; Wolf Motor Function Test). As such, the upper extremity section of the 
Fugl-Meyer Scale (FM) will assess whether changes occur in upper extremity movement, as 
anticipated in Hypothesis 1. 
The Comfy Dorsal Hand Splint (Comfy Splints, Lenjoy Medical Engineering, Inc.) (Figure 2) was
chosen for the comparison device, as splints are 
among the most commonly-prescribed products
post-stroke and are used to place the affected arm
in a functional position and prevent deformity. The
dorsal splint was chosen (as opposed to a palmar
splint) as it leaves the digits free for object
manipulation and task performance. 

“Functional Assistance provided by Myoelectric Elbow-wrist-hand orthoses" (FAME) 
Myomo FAME Protocol_v.4 
10JUL2017 
5 
 
Secondary Outcome Measures (Aim 2): 
● 
Demonstration of orthotic-assisted increases in motor ability alone is not sufficient to warrant 
clinical use of a device. Indeed, increases in orthotic-assisted UE movement must translate 
into improvements in functional outcomes. Additionally, the MyoPro 2 Motion G provides full 
active assisted ROM at the elbow to facilitate increased ability to carry out proximally-based 
functional tasks. While useful in assessing distal functional abilities, many distally based 
measures may not fully quantify an increased ability to carry out more proximally-based, 
gross motor tasks involving the elbow. 
 
As such, investigators will administer a battery of proximally-based, commonly-performed 
functional tasks (ICF: activity). This battery was used in our preliminary work leading to the 
current application, and consists of: (a) stabilizing a mixing bowl while stirring, (b) simulated 
drinking, (c) picking up a laundry basket, (d) putting an item in a laundry basket, (e) opening 
deodorant, (f) opening a pill bottle, (g) cutting a block of cheese, and (h) sweeping. Quality 
of movement on each task and sub-task will be rated using a 6-point ordinal scale 
(0=performs no part of task, does not attempt with the affected arm; 5=performs normally) 
and performance of each task will be timed, with 60 seconds allotted for each subtask. This 
battery will provide valuable information regarding proximal and gross distal functional 
abilities as well as speed of task completion. 
 
Importantly, in pilot work leading to this study, our sample size was not large enough to fully 
determine the battery’s psychometrics, but internal consistency was demonstrated. While 
not a primary aim of this study, the study biostatistician will perform full psychometric 
analyses to determine the measurement properties of this instrument, as described later. 
 
● 
The Box and Block Test (B&B) (ICF: activity) is suggested to determine whether changes 
occur in UE gross manual dexterity. During the test, the subject is seated in front of a 
wooden box with a partition in the middle, and is asked to move colored blocks from one 
side of the box, over the partition, to the other side. The number of blocks moved in one 
minute is recorded. The test’s test-retest reliability and validity have been shown in 
stroke.14,15 
 
Table 1: Screening and Outcome Measures 
 
Measure 
Measurement Domain 
Timepoint(s) Administered 
Screening Measures 
Manual Muscle Test (MMT) 
Arm muscle strength 
Visit #1 (screening) 
Passive and Active Range of Motion 
(PROM/AROM) 
Upper Extremity Physiology/ 
Kinesiology 
Visit #1 (screening) 
0-10 Numeric Pain Rating Scale 
Pain in paretic UE 
Visit #1 (screening) 

“Functional Assistance provided by Myoelectric Elbow-wrist-hand orthoses" (FAME) 
Myomo FAME Protocol_v.4 
10JUL2017 
6 
Alexander Apraxia Scale 
Perceptual impairment/Apraxia 
Visit #1 (screening) 
Modified Mini Mental Status 
Examination 
Gross cognitive status 
Visit #1 (screening) 
Screening and Demographics Forms 
Treatment history 
Visit #1 (screening) 
Patient Health Questionnaire-9 (PHQ9) 
Depression severity 
Visit #1 (screening) 
Modified Ashworth Scale 
Upper Extremity (UE) spasticity 
Visit #1 (screening) 
Upper Extremity (UE) Fugl-Meyer 
(primary outcome measure) 
Upper Extremity Impairment 
Visit #1 (Screening), Visit #2, 
Visit #3, Visit #4 
Outcome Measures 
Upper Extremity (UE) Fugl-Meyer 
(primary outcome measure) 
Upper Extremity Impairment 
Visit #1 (Screening), Visit #2, 
Visit #3, Visit #4 
Box and Blocks Test 
UE gross manual dexterity 
Visit #2, Visit #3, Visit #4 
Battery of functional tasks 
Activities of Daily Living 
Visit #2, Visit #3, Visit #4 
 
Suggested Procedures for Standardization of Raters on UE Outcome Measures: 
At least one “rating” therapist who is blinded to randomization assignments should be identified 
and hired for this study from each site. Each individual will undergo extensive inservicing using 
uniform procedures to assure that outcome testing has high intra-rater and inter-rater reliability 
(i.e., the therapist scores each measure in a way that is consistent with him/herself, as well as 
with raters at other sites). Specifically, before the first subject is enrolled at each site, it is 
recommended that the rating therapist at each site be “certified” on the FM by demonstrating 
his/her rating skills on these measures during videotaped testing standardization sessions. 
During the videotaped session, he/she performs the measure in its entirety on a subject with 
stroke, and completes a case report form indicating his/her scores for each FM item. When a 
therapist completes the videotaped certification session, the testing videos and accompanying 
completed case report forms are then uploaded to a secure ftp site or to Google documents. 
Each rater’s video from each site is reviewed externally by a single individual hired for the trial. 
Appropriate mastery of the testing content is attained when there is 90% agreement between 
the tester’s score on each measure with the manual of procedures. Certification would last for 6 
months and procedures for carrying out each test of interest would be detailed in a standardized 
manual of procedures. 
 
This same methodology has been used in stroke rehabilitation trials by this laboratory for over a 
decade, including two ongoing multicenter studies for which this laboratory is organizing all 
outcome training and testing. Moreover, this same methodology of “certifying” raters has been 
used in most multicenter stroke rehabilitation studies in which UE behavioral measures have 
been administered, including Everest, ExCITE, and, most recently, ICare. 
 
 

“Functional Assistance provided by Myoelectric Elbow-wrist-hand orthoses" (FAME) 
Myomo FAME Protocol_v.4 
10JUL2017 
7 
Data Collection Procedures 
Study Protocol Overview: 
All subjects will be requested to participate in 4 study visits lasting no more than 3 hours each, 
as well as three training sessions of approximately 1 hour each (Table 2). During the first study 
visit, the study will be explained to the subject and written informed consent will be obtained. 
Then, all screening measures (listed in Table 1) will be administered and, if the subject meets all 
inclusion criteria, they will move on to the educational sessions. Between visits #1 and #2, the 
subjects will receive two education sessions, (1 one-hour training session and 1 two-hour  
training session) on both the MyoPro 2 Motion G and comparison splint. During study visits #2, 
#3 & #4, the subject will undergo all outcome measures (Table 1) in all three conditions (one 
condition per visit to minimize fatigue) in randomized order. A summary of the study timeline nd 
a more detailed description of the study design follows. 
 
Timeline for each research subject: 
Subjects will have a maximum of 3 weeks to complete all visits beginning from the date of consent. 
There should not be more than one visit and/or testing session completed in the same day to reduce 
the likelihood of patient fatigue. 
 
Description of Study Visits: 
Visit 1 (Consent, screen): During the first visit, each volunteer will sign an informed consent 
for participation in this study. Next, subjects will undergo all screening measures as listed in 
inclusion criteria. For each subject, a study team member who will be trained on the use of the 
MyoPro 2 Motion G device will help don the device to their paretic UE, and select appropriate 
locations on their arm for the external EMG sensors. If a subject meets all inclusion criteria, 
they will continue on to undergo training sessions. 
 
The evaluation process to examine the subjects’ eligibility will be performed by the PI and/or 
study coordinator at each site. The orthosis fitting process will be done in accordance with 
good orthotics practices outlined in the American Academy of Orthopaedic Surgeons (AAOS) 
Atlas of Orthoses and Assistive Devices. After the evaluation and fitting process, the study 
therapist will tune the settings on the EMG system, teach the subject the donning and doffing 
process for the orthosis, and educate the user on the capabilities and functionality of the 
MyoPro 2 Motion G brace. 
 
Two Education sessions: Subjects will return to complete two education sessions. Training 
sessions #1 will last 2 hours, with 1 hour of training on the MyoPro and 1 hour of training on 
the splint. Training session #2 will last one hour, with 30 minutes of additional training on the 
MyoPro and 30 minutes additional training on the splint. 
 
MyoPro 2 Motion G training: MyoPro 2 Motion G training will consist of simple 
repetitions of activating the myoelectric system by attempting to flex muscle groups and 
seeing the system response. These exercises teach the users to understand the 
relationship between their EMG signal and the motions and forces generated by the 
device. The users will practice basic movements, including flexing and extending the 
elbow, opening and closing the hand unit, and grasping objects with the hand. This 
requires a great deal of cognitive effort and often some adjustments to the device and its 

“Functional Assistance provided by Myoelectric Elbow-wrist-hand orthoses" (FAME) 
Myomo FAME Protocol_v.4 
10JUL2017 
8 
interface with the individual’s muscles by the study therapist. Subjects will be taught the 
donning and doffing process for the orthosis, as well as learn the capabilities and 
functionality of the MyoPro 2 Motion G brace. 
 
Splint training: Tasks performed in comparison device training sessions will be identical 
to those performed during MyoPro 2 Motion G training (i.e., flexion/extension of the 
elbow and fingers, object manipulation) to ensure training between devices is uniform. 
Subjects will also undergo training on how to adjust the device depending on which task 
is being practiced. Subjects will be taught the donning and doffing process for the 
orthosis, as well as learn the capabilities and functionality of resting splint. 
 
Visit 2 (Assessment): Subjects will perform all aforementioned outcome measures in the first 
assessment condition to which they were randomized (i.e., MyoPro 2 Motion G, splint, or no 
device). Randomization will be performed by a study coordinator hired for this study using a 
computer-generated randomization table, and will be revealed to the study therapist prior to the 
study visit. A latin square will be used to counterbalance the order of conditions. 
 
Visit 3 (Assessment): Subjects will perform all aforementioned outcome measures in the 
second condition to which they were randomly assigned. 
 
Visit 4 (Assessment): Subjects will perform all aforementioned outcome measures in the third 
condition to which they were randomly assigned. 
 
Data Analyses 
Power and Sample Size Justification: 
For the past 9 months, members of the study team have collected data comparing the effect of 
wearing the MyoPro Motion G versus not wearing the MyoPro Motion G on UE movement in 
moderately impaired stroke survivors. This work showed a mean change of 8.72 + 7.1 points on 
the UE FM when subjects wore the MyoPro Motion G (Table 3). From this work, we have 
formed the primary study hypothesis, which is that subjects will exhibit significantly higher 
scores on the UE FM when using the MyoPro 2 Motion G compared to scores when using the 
splint and no device. 
 
Table 3:  Pilot Data Leading to the Current Trial 
condition 
Method 
Mean 
99% CL Mean 
Std Dev 
99% CL Std 
Dev 
99% UMPU CL 
Std Dev 
with 
27.2778 21.9152 
32.6403 
7.8501 5.4157 
13.5603 5.3232 
13.2488 
without 
18.5556 14.2528 
22.8583 
6.2987 4.3454 
10.8803 4.2712 
10.6304 
Diff (1-2) 
Pooled 
8.7222 
2.2498 
15.1947 
7.1168 5.4042 
10.2156 5.3562 
10.1038 
Diff (1-2) 
Satterthwaite 
8.7222 
2.2318 
15.2127 

“Functional Assistance provided by Myoelectric Elbow-wrist-hand orthoses" (FAME) 
Myomo FAME Protocol_v.4 
10JUL2017 
9 
 
Method 
Variances 
DF 
t Value 
Pr > |t| 
Pooled 
Equal 
34 
3.68 
0.0008 
Satterthwaite 
Unequal 
32.475 
3.68 
0.0008 
 
Equality of Variances 
Method 
Num DF 
Den DF 
F Value 
Pr > F 
Folded F 
17 
17 
1.55 0.3729 
 
Based on the above work, we have taken a very conservative estimate of effect size (Table 4), 
and estimate that a sample size of n=49, will provide approximately 80% power to detect a 
medium effect size of f=0.2521 when alpha is set to 0.05 for repeated measures MANOVA with 
1 group and 3 measurements, using the F-distribution. (Figure 2). Given a liberal attrition rate of 
20% and the need to examine age-associated differences in depth (i.e., covariates such as age 
and time since stroke), we plan to enroll up to a total of 75 participants (n = 75) to ensure adequate 
power for the planned analyses. 
 
Table 4: Point Estimate and 95% Confidence Interval Effect Size, d and f 
 
Effect Size 
Point Estimate 
95% Lower Bound 
95% Upper Bound 
d 
1.22667 
0.50413 
1.93409 
f 
0.6134 
0.2521 
0.9670 
 
Figure 2:  Differences Between Independent Means and Power/Sample Size Estimates 
  

“Functional Assistance provided by Myoelectric Elbow-wrist-hand orthoses" (FAME) 
Myomo FAME Protocol_v.4 
10JUL2017 
10
 
 
Desired 
Power 
Required 
Sample Size 
0.600000 
32.393509 
0.610000 
33.035972 
0.620000 
33.689708 
0.630000 
34.355391 
0.640000 
35.033746 
0.650000 
35.725556 
0.660000 
36.431665 
0.670000 
37.152989 
0.680000 
37.890523 
0.690000 
38.645352 
0.700000 
39.418662 
0.710000 
40.211754 
0.720000 
41.026061 
0.730000 
41.863165 
0.740000 
42.724820 
0.750000 
43.612981 
0.760000 
44.529834 
0.770000 
45.477833 
0.780000 
46.459755 
0.790000 
47.478749 
0.800000  
48.538415 
0.810000 
49.642895 
0.820000 
50.796985 
0.830000 
52.006284 
0.840000 
53.277389 
0.850000 
54.618146 
0.860000 
56.037995 
 
0.870000 
57.548430 
0.880000 
59.163657 
0.890000 
60.901520 
0.900000 
62.784876 
0.910000 
64.843687 
0.920000 
67.118332 
0.930000 
69.665121 
0.940000 
72.566040 
0.950000 
75.947367 
 
Data Analyses: 
Primary Study Hypothesis: Subjects will exhibit significantly higher scores on the UE FM 
when using the MyoPro 2 Motion G compared to scores when using the splint and no device. 

“Functional Assistance provided by Myoelectric Elbow-wrist-hand orthoses" (FAME) 
Myomo FAME Protocol_v.4 
10JUL2017 
11
 
Secondary Study Hypotheses: 
Hypothesis 2a: Subjects will exhibit significantly higher scores on the B&B when using the 
MyoPro 2 Motion G compared to scores when using the splint and no device. 
Hypothesis 2b: Subjects will exhibit significantly higher quality scores and decreased time 
on the battery of functional tasks when using the MyoPro 2 Motion G compared to scores 
when using the splint and no device. 
 
We will evaluate primary and secondary study hypotheses using repeated measures MANOVA. 
The independent variable is device usage and has three levels: (1) performance with MyoPro 2 
Motion G, (2) performance with the resting hand splint, and (3) performance without device. 
The multiple dependent variables include: (1) UE movement as measured by the UEFM 
(primary hypothesis), (2) dexterity as measured by the B&B (hypothesis 2a), and (3) functional 
movement as measured by the novel battery (hypothesis 2b). A significant main effect and/ or 
interaction effect will be investigated in greater detail using univariate tests. These analyses 
are powered to permit inclusion of 1-2 covariates such as participant age and time since stroke. 
Post-hoc analyses will include a specific contrast for participants aged 65 and over. 
 
Psychometric Analyses of Functional Test Battery 
In addition to analyses of functional tasks, we will perform psychometric analyses on the 
battery of functional tasks. This is expected to produce a validated functional outcome 
measure that can be used in people with moderate UE impairments resulting from stroke and 
other disorders, which will fill a gap in the field. 
 
To determine reliability, we will use multiple measures of internal consistency, including 
Cronbach’s ɑ, as well as ordinal ɑ and Gugiu’s bootstrap reliability. While Cronbach’s ɑ has 
been traditionally used in psychometric analyses, it is based on assumptions of interval level 
items and, thus, relatively poorly situated to measure reliability of measures that are 
comprised of items that use ordinal level scales, as is the case with our functional battery. 
The latter easures in combination with Cronbach’s ɑ are expected to provide a more rigorous 
ascertainment of internal consistency. 
 
To ascertain dimensionality we will use latent parallel analyses (LPA) in which we: (a) generate 
a polychoric correlation matrix for battery items; (b) using the polychoric correlation matrix as 
input for LPA; (c) conducting Monte Carlo simulations to create 250 random datasets designed 
to match the number of respondents (n=75) and distributional characteristics of battery items; 
and (d) compute, extract, and compare eigenvalues for the real and random datasets. 
 
Lastly we will ascertain convergent validity between the functional battery items and the UE FM 
using the Pearson correlation coefficient (r). 

“Functional Assistance provided by Myoelectric Elbow-wrist-hand orthoses" (FAME) 
Myomo FAME Protocol_v.4 
10JUL2017 
12 
References 
 
 
1 Broeks JG, Lankhorst GJ, Rumping K, Prevo AJ: The long-term outcome of arm function after 
stroke: results of a follow-up study. Disabil Rehabil 1999;21:357–364 
2 Mayo N. Activity, participation, and quality of life 6 months poststroke. Arch Phys Med Rehabil 
2002;83:1035–1042. 
3 Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D., et al. Effect of constraint- 
induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE 
randomized clinical trial. JAMA 2006;296:2095-2104. 
4 Page SJ, Levine P, Leonard A. Mental practice in chronic stroke: Results of a randomized, 
 
placebo controlled trial. Stroke 2007;38:1293-7. 
 
5 Page SJ, Boe S, Levine P. What are the “ingredients” of modified constraint-induced therapy? 
An evidence based review, recipe, and recommendations. Restor Neurol Neurosci 2013;31:299- 
309. 
6  Wolf SL, Binder-MacLeod SA. Electromyographic biofeedback applications to the hemiplegic 
 
patient: changes in upper extremity neuromuscular and functional status. Phys Ther 
1983;63:1393–1403. 
7 Stein J, Narendran K, McBean J, Krebs K, Hughes R: Electromyography controlled exoskeletal 
 
upper-limb–powered orthosis for exercise training after stroke. Am J Phys Med Rehabil 
2007;86:255–261. 
8 Fasoli SE, Krebs HI, Stein J, Frontera WR, Hogan N. Effects of robotic therapy on motor 
 
impairment and recovery in chronic stroke. Arch Phys Med Rehabil 2003;84:477-82. 
 
9 Milot MH, Spencer SJ, Chan V, Allington JP, Klein J, Chou C, Bobrow JE, Cramer SC, 
Reinkensmeyer DJ. A crossover pilot study evaluating the functional outcomes of two different 
types of robotic movement training in chronic stroke survivors using the arm exoskeleton 
BONES. J Neuroeng Rehabil 2013;10:112. 

“Functional Assistance provided by Myoelectric Elbow-wrist-hand orthoses" (FAME) 
Myomo FAME Protocol_v.4 
10JUL2017 
13 
 
 
10 McLean L & Scott RN. The Early History of Myoelectric Control of Prosthetic Limbs (1945 – 
1970). In A. Muzumdar (Ed.), Powered Upper Limb Prostheses (pp1-2). 2004. 
11 Page SJ, Hill V, White S. Portable upper extremity robotics is as efficacious as upper 
extremity rehabilitative therapy: a randomized controlled pilot trial. Clin Rehabil 2013;27:494- 
503. 
12 Page SJ, Hermann VH, Levine PG, Lewis E, Stein J, DePeel J. Portable neurorobotics for the 
severely affected arm in chronic stroke: a case study. J Neurol Phys Ther 2011;35:41-6. 
13 Kim G, Rivera J, Stein J. Combined Clinic-Home Approach for Upper Limb Robotic Therapy 
After Stroke: A Pilot Study. Arch Phys Med Rehabil 2015 Dec;96(12):2243-8. 
14 Desrosiers J, Bravo G, Hébert R, Dutil É & Mercier L. Validation of the box and block test as a 
measure of dexterity of elderly people: reliability, validity and norms studies. Archives of  
Physical Medicine and Rehabilitation 1994;75:751-755. 
15  Cromwell F. Occupational therapists manual for basic skills assessment: primary 
prevocational evaluation. 1994. Pasadena, (CA): Fair Oaks Printing; 29-31.