N/A
N=16
Myoelectric Upper Limb Orthosis Use by Persons With TBI and Stroke
Traumatic Brain Injury · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03215771 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA) — 7.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MyoPro Motion-G (Device); Motor Learning-Based Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA) |
7.5 | — |
| SECONDARY Modified Ashworth Scale |
-2.3 | — |
| SECONDARY Chedoke Arm and Hand Activity Inventory (CAHAI) |
8.8 | — |
| SECONDARY Orthotic and Prosthetic Users' Survey Satisfaction Module (OPUSsat) |
26.7 | — |
| SECONDARY Craig Handicap Assessment and Rehabilitation Technique (CHART) |
34.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03215771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.