Trial Outcomes & Findings for Robotic Brace Incorporating Electromyography for Moderate Affected Arm Impairment After Stroke (NCT NCT01654315)

Results Overview

The upper extremity section of the Fugl-Meyer Scale (FM) will assess whether changes occur in paretic upper extremity motor impairment. The FM has been used extensively in stroke recovery studies, and is highly recommended for "use in clinical trials designed to evaluate changes in motor impairment following stroke." The items on the measure require the subject to perform various movements with the affected upper extremity, and each item is scored from 0 (cannot perform) to 2 (performs normally). Item are then summed for a total score. The total score ranges are 0 to 66, with a higher score representing less upper extremity impairment (and, thus, a relatively "better" score on the measure than a lower score).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

Administered twice before the intervention period. These two scores are averaged to provide a composite score that is compared to average score for each group that is collected 1 week after intervention

Results posted on

2022-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: Myomo Only Group Experimental: Myomo Only Group Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period. Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.	Experimental: Myomo + RTP Group Experimental: Myomo + RTP Group Patients are administered rehabilitative therapy using both the Myomo robotic device and RTP targeting their affected arms on 3 days/week during a 8 week period. Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.	Active Comparator: RTP Group Active Comparator: RTP Group Patients are administered rehabilitative therapy using only RTP that is targeting their affected arms on 3 days/week during a 8 week period. Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.
Overall Study STARTED	15	10	9
Overall Study COMPLETED	15	10	9
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Robotic Brace Incorporating Electromyography for Moderate Affected Arm Impairment After Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Myomo Only Group n=15 Participants Experimental: Myomo Only Group Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period. Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.	Experimental: Myomo + RTP Group n=10 Participants Experimental: Myomo + RTP Group Patients are administered rehabilitative therapy using both the Myomo robotic device and RTP targeting their affected arms on 3 days/week during a 8 week period. Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.	Active Comparator: RTP Group n=9 Participants Active Comparator: RTP Group Patients are administered rehabilitative therapy using only RTP that is targeting their affected arms on 3 days/week during a 8 week period. Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.	Total n=34 Participants Total of all reporting groups
Age, Continuous	54.69 years STANDARD_DEVIATION 8.6 • n=5 Participants	52.28 years STANDARD_DEVIATION 13.0 • n=7 Participants	57.22 years STANDARD_DEVIATION 7.7 • n=5 Participants	54.9 years STANDARD_DEVIATION 9.4 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Region of Enrollment United States	15 participants n=5 Participants	10 participants n=7 Participants	9 participants n=5 Participants	34 participants n=4 Participants

PRIMARY outcome

Timeframe: Administered twice before the intervention period. These two scores are averaged to provide a composite score that is compared to average score for each group that is collected 1 week after intervention

The upper extremity section of the Fugl-Meyer Scale (FM) will assess whether changes occur in paretic upper extremity motor impairment. The FM has been used extensively in stroke recovery studies, and is highly recommended for "use in clinical trials designed to evaluate changes in motor impairment following stroke." The items on the measure require the subject to perform various movements with the affected upper extremity, and each item is scored from 0 (cannot perform) to 2 (performs normally). Item are then summed for a total score. The total score ranges are 0 to 66, with a higher score representing less upper extremity impairment (and, thus, a relatively "better" score on the measure than a lower score).

Outcome measures

Outcome measures
Measure	Experimental: Myomo Only Group n=15 Participants Experimental: Myomo Only Group Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period. Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.	Experimental: Myomo + RTP Group n=10 Participants Experimental: Myomo + RTP Group Patients are administered rehabilitative therapy using both the Myomo robotic device and RTP targeting their affected arms on 3 days/week during a 8 week period. Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.	Active Comparator: RTP Group n=9 Participants Active Comparator: RTP Group Patients are administered rehabilitative therapy using only RTP that is targeting their affected arms on 3 days/week during a 8 week period. Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.
Impairment in the Affected Upper Extremity as Measured by the Fugl Meyer Scale.	19.6 units on a scale Standard Deviation 3.8	18.0 units on a scale Standard Deviation 5.9	17.6 units on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: Administered twice before the intervention period. These two scores are averaged to provide a composite score that is compared to average score for each group that is collected 1 week after intervention

The Arm Motor Activity Test (AMAT) was the secondary outcome for this study and was used to determine whether changes occur in activity limitation. The AMAT is a 13-item test in which valued activities are rated according to a functional ability scale that examines affected limb use 0 = no use, 1 = very slight use, 2 = slight use, 3 = moderate use, 4 = almost normal use, 5 = normal use;) and a Quality of Movement Scale (0 = no use, 1 = very poor, 2 = poor, 3 = fair, 4 = almost normal, 5 = normal. ). Therefore, the highest score that one can attain on either scale is 65.0 (which would mean that the person scored a perfect score of "5" on each of the thirteen items).

Outcome measures

Outcome measures
Measure	Experimental: Myomo Only Group n=15 Participants Experimental: Myomo Only Group Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period. Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.	Experimental: Myomo + RTP Group n=10 Participants Experimental: Myomo + RTP Group Patients are administered rehabilitative therapy using both the Myomo robotic device and RTP targeting their affected arms on 3 days/week during a 8 week period. Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.	Active Comparator: RTP Group n=9 Participants Active Comparator: RTP Group Patients are administered rehabilitative therapy using only RTP that is targeting their affected arms on 3 days/week during a 8 week period. Myomo Robotic Arm: Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.
Arm Motor Ability Test (AMAT)	29.21 units on a scale Standard Deviation 8.67	28.62 units on a scale Standard Deviation 8.38	25.33 units on a scale Standard Deviation 5.24

Adverse Events

Experimental: Myomo Only Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental: Myomo + RTP Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Comparator: RTP Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stephen Page

The Ohio State University

Phone: 614-292-5490

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place