Wearable Robotic Functional Assistance for Stroke Rehabilitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Myomo
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Motor Activity Log
Study Overview
Brief Summary
This study aims to evaluate the effectiveness of using the myomo e100 wearable robotic rehabilitation system for increasing functional independence and long term rehabilitation of chronic stroke victims with a hemiparetic upper extremity.
Detailed Description
This is a case controlled study for evaluation of the effectiveness of using the myomo e100 wearable robotic rehabilitation for upper arm therapy following stroke.
The intervention for the study will be for the control group- 6-8 weeks of therapeutic exercise and functional training for a total of 18 hours of intervention, or the case group- 6-8 weeks of therapeutic exercise and functional training with the use of the AJB for a total of 18 hours of intervention. Each session will be one hour in length. The length of the study and length of each session is per standard rehabilitation protocol that has been well documented in previous studies as well as the pilot study regarding the AJB. A pre and post test with a 3 month follow up of all measures will be included in the study.
Study procedures will focus on performing functional tasks using the e100.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Medically Stable
- •Cognitive Awareness
- •Weakness in upper arm
- •Over 1 year post CVA
- •not engaged in any other upper arm therapies
Exclusion Criteria
- •Rashes, open wounds or skin sensitivity on arm
- •Very high elbow tone (arm rigid in flexion or extension)
Outcomes
Primary Outcomes
Motor Activity Log
Fugl-Meyer Upper Arm Function
Wolf Motor Function
SF-36 QOL Survey
Range of Motion
Muscle Strength Test
Secondary Outcomes
No secondary outcomes reported