Myoelectric Upper Limb Orthosis Use by Persons With TBI and Stroke

Not Applicable

Completed

• Conditions: Traumatic Brain Injury; Stroke
• Interventions: Device: MyoPro Motion-G; Other: Motor Learning-Based Therapy

• Registration Number: NCT03215771
• Lead Sponsor: Northwestern University

Brief Summary

The objective of this study was to document longitudinal outcomes in persons with traumatic brain injury (TBI) or stroke using the myoelectric upper limb orthosis with powered elbow and grasp in conjunction with motor learning-based therapy using both patient centric performance and patient reported outcome measures. Longitudinal observation allowed the investigators to detect both the initial therapeutic effects as well as the later functional outcomes of orthosis use. The investigators planned to recruit 15 Veterans and non-veterans who had TBI or stroke and upper limb impairment. The study required 29 visits over 22 weeks and was divided into three parts: orthotic fitting, therapy/training (9 weeks), and home use (9 weeks). Therapeutic and functional benefits were evaluated every 2 to 3 weeks over 18 weeks using simple, short clinical tests.

Detailed Description

This study had two aims: (1) to evaluate therapeutic and neuroplastic effects of a myoelectric upper limb orthosis in conjunction with motor learning-based therapy and (2) to evaluate the functional effects of a myoelectric upper limb orthosis in conjunction with motor learning-based therapy. The investigators planned to recruit 15 Veterans and non-veterans who had Traumatic Brain Injury (TBI) or stroke and upper limb impairment, were over 18 years of age and a minimum of 6 months from injury. The study required 29 visits over 22 weeks and was divided into three parts: orthotic fitting, therapy/training (9 weeks), and home use (9 weeks). Therapeutic and functional benefits were evaluated every 2 to 3 weeks over 18 weeks using simple, short clinical tests.

Subjects were enrolled in the study if they met eligibility criteria assessed at a screening visit. Once enrolled subjects were fit with a custom fabricated MyoPro Motion-G elbow-wrist-hand orthosis following standard clinical procedures. This process required up to three visits to cast, trial fit and deliver the orthosis. Subjects then participated in a standard-of-care motor learning based therapy protocol in conjunction with the PERL ("Push Eat Reach Lift") training program recommended by Myomo, which consists of a 9 week, 18 session training plan. Every second week, there was one session that combined therapy/training and outcomes evaluation.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Primary Completion: 2020-06-12
• Study Completion: 2020-06-12
• Results First Submitted: 2021-06-09
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-12
• Last Update Submitted: 2021-07-13
• Results First Posted: 2021-07-14
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• over 18 years of age
• minimum 6 months since injury
• elbow, forearm, wrist and hand have full motion with little resistance from muscles when moved by someone else
• some ability to actively move the shoulder
• able to generate consistent and detectable electrical signals from the upper arm and forearm muscles
• able to read and comprehend the English language
• able to follow two-stage command
• cognitive abilities sufficient to perform testing and training protocols
• able to tolerate functional tasks for 60 minutes without excessive fatigue
• medically and psychologically stable
• at home support from a family member or care giver if needed

Read More

Exclusion Criteria

• elbow, forearm, wrist and hand have less than full motion with high resistance from muscles when moved by someone else
• shoulder instability, pain or dislocation
• unable to safely support the weight of arm with added weight of the device without pain
• less than 12 weeks since botulinum toxin injection in the impaired arm
• new therapies/medications planned during study period
• skin rash or open wound on impaired arm
• inability to detect light touch or pain on impaired arm
• involuntary movements of the impaired arm
• pain or hypersensitivity in the impaired arm
• inability to understand English

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MyoPro + Motor Learning-Based Therapy	MyoPro Motion-G	Subjects received 9 weeks of motor learning-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 + Motor Learning-Based Therapy	Motor Learning-Based Therapy	Subjects received 9 weeks of motor learning-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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Craig Handicap Assessment and Rehabilitation Technique (CHART)	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.
Modified Ashworth Scale	Change in Modified Ashworth Scale from Baseline at Week 18	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.
Orthotic and Prosthetic Users' Survey Satisfaction Module (OPUSsat)	Change in Orthotic and Prosthetic Users' Survey satisfaction module (OPUSsat) from Baseline at Week 18	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.
Chedoke Arm and Hand Activity Inventory (CAHAI)	Change in Chedoke Arm and Hand Activity Inventory (CAHAI) from Baseline at Week 18	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.

Trial Locations

Locations (1)

Louis Stokes Cleveland VA Medical Center; 🇺🇸 Cleveland, Ohio, United States