Trial Outcomes & Findings for Myoelectric Upper Limb Orthosis Use by Persons With TBI and Stroke (NCT NCT03215771)

Results Overview

Evaluation of motor impairment of the upper limb. Thirty-three items of movement coordination and reflex activity are scored with a 3-point Likert scale (0-66 points total) where higher scores represent less arm impairment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

Change in Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA) from Baseline at Week 18

Results posted on

2021-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	MyoPro + Motor Based Learning Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
Overall Study STARTED	16
Overall Study Stroke Subjects	8
Overall Study TBI Subjects	8
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	MyoPro + Motor Based Learning Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MyoPro + Motor Based Learning n=13 Participants Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program. MyoPro Motion-G: The MyoPro Motion-G is a custom-fabricated elbow-wrist-hand myoelectric orthosis.
Age, Continuous	50.62 years STANDARD_DEVIATION 19.91 • n=13 Participants
Sex: Female, Male Female	8 Participants n=13 Participants
Sex: Female, Male Male	5 Participants n=13 Participants

PRIMARY outcome

Timeframe: Change in Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA) from Baseline at Week 18

Population: combined results from 6 TBI and 7 stroke subjects

Evaluation of motor impairment of the upper limb. Thirty-three items of movement coordination and reflex activity are scored with a 3-point Likert scale (0-66 points total) where higher scores represent less arm impairment.

Outcome measures

Outcome measures
Measure	MyoPro + Motor Based Learning n=13 Participants Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use of the MyoPro along with a home exercise program. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA)	7.5 score on a scale Interval 5.4 to 9.7

SECONDARY outcome

Timeframe: Change in Modified Ashworth Scale from Baseline at Week 18

Population: combined results from 6 TBI and 7 stroke subjects

Using a 6-point scale, the clinician evaluates resistance to passive movement about a joint with varying degrees of velocity as follows: 0 No increase in muscle tone. 1 Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension. 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM. 2 More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved. 3 Considerable increase in muscle tone, passive movement difficult. 4 Affected part(s) rigid in flexion or extension. A lower score represents less resistance to passive movement.

Outcome measures

Outcome measures
Measure	MyoPro + Motor Based Learning n=13 Participants Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use of the MyoPro along with a home exercise program. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
Modified Ashworth Scale	-2.3 score on a scale Interval -2.9 to -1.7

SECONDARY outcome

Timeframe: Change in Chedoke Arm and Hand Activity Inventory (CAHAI) from Baseline at Week 18

Population: combined results from 6 TBI and 7 stroke subjects

Used to assess performance of activities of daily living (ADLs). Measure consists of 13 functional tasks scores and the score for each functional task are summed to compute the total score. Scoring of each task is based on a 7-point scale (1=unable; 7=normal performance; minimum score is 13 points; maximum score is 91 points), where higher scores represent better performance of ADLs.

Outcome measures

Outcome measures
Measure	MyoPro + Motor Based Learning n=13 Participants Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use of the MyoPro along with a home exercise program. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
Chedoke Arm and Hand Activity Inventory (CAHAI)	8.8 score on a scale Interval 6.2 to 11.4

SECONDARY outcome

Timeframe: Change in Orthotic and Prosthetic Users' Survey satisfaction module (OPUSsat) from Baseline at Week 18

Population: combined results from 6 TBI and 7 stroke subjects

An 11-item patient-reported survey that assesses satisfaction with device using a 5-point Likert scale. Satisfaction with device is the sum of the scores (score range: 11-55), where higher scores indicate better satisfaction with device.

Outcome measures

Outcome measures
Measure	MyoPro + Motor Based Learning n=13 Participants Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use of the MyoPro along with a home exercise program. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
Orthotic and Prosthetic Users' Survey Satisfaction Module (OPUSsat)	26.7 score on a scale Interval 15.9 to 37.6

SECONDARY outcome

Timeframe: Change in Craig Handicap Assessment and Rehabilitation Technique (CHART) from Baseline at Week 18

A life-role participation survey measuring the level of handicap using objectively observable behaviors in five dimensions: physical, social, cognitive, mobility, and occupation. Survey responses are combined using formulas for each domain. The score in each domain is capped at 100 (total score range: 0-500). Higher scores represent better self-reported participation.

Outcome measures

Outcome measures
Measure	MyoPro + Motor Based Learning n=13 Participants Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use of the MyoPro along with a home exercise program. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
Craig Handicap Assessment and Rehabilitation Technique (CHART)	34.9 score on a scale Interval 5.3 to 64.5

Adverse Events

MyoPro + Motor Based Learning

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. Stefania Fatone, Principle Investigator

Northwestern University

Phone: 3125035717

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place