Clinical trial NCT03215771: Myoelectric Upper Limb Orthosis Use by Persons With TBI and Stroke
Official title: Longitudinal Observation of Myoelectric Upper Limb Orthosis Use Among Veterans With Upper Limb Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Stroke
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Louis Stokes VA Medical Center
name: Myomo
First posted: 2017-07-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA)
timeFrame: Change in Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA) from Baseline at Week 18
Secondary outcomes:
measure: Modified Ashworth Scale
timeFrame: Change in Modified Ashworth Scale from Baseline at Week 18
measure: Chedoke Arm and Hand Activity Inventory (CAHAI)
timeFrame: Change in Chedoke Arm and Hand Activity Inventory (CAHAI) from Baseline at Week 18
measure: Orthotic and Prosthetic Users' Survey Satisfaction Module (OPUSsat)
timeFrame: Change in Orthotic and Prosthetic Users' Survey satisfaction module (OPUSsat) from Baseline at Week 18
measure: Craig Handicap Assessment and Rehabilitation Technique (CHART)
timeFrame: Change in Craig Handicap Assessment and Rehabilitation Technique (CHART) from Baseline at Week 18
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes Cleveland VA Medical Center
state: Ohio
Study officials:
References:
citation: Pundik S, McCabe J, Skelly M, Salameh A, Naft J, Chen Z, Tatsuoka C, Fatone S. Myoelectric Arm Orthosis in Motor Learning-Based Therapy for Chronic Deficits After Stroke and Traumatic Brain Injury. Front Neurol. 2022 Feb 8;13:791144. doi: 10.3389/fneur.2022.791144. eCollection 2022.