Cerebrovascular Accident, Stroke
Conditions
Keywords
Stroke, Rehabilitation, Dyssynergia, Robotics, AMES, Cerebrovascular Accident
Brief summary
Subjects will receive 30 treatments with AMES, to the proximal arm which has been affected by a chronic stroke.
Detailed description
This study seeks to determine whether 30 treatments with AMES, to the proximal affected arm of subjects with chronic stroke, will improve subjects' proximal arm active range-of-motion. We hypothesize that the combination of assisted movement, torque biofeedback, and muscle vibration will reduce impairment (i.e., increase strength and range-of-motion; decrease inappropriate patterns of muscle contraction) and, thereby, lead to more accurate reaching with the proximal arm.
Interventions
DEVICE30 PAAD treatments
Subjects will don a shirt with pockets at the elbow and shoulder in each of which a muscle vibrator is located. The subject will then place the affected arm in the PAAD. The PAAD will range the affected arm, at the shoulder in the adduction-abduction direction, and at the elbow in the flexion-extension direction. The subject will assist volitionally this motion, and visual feedback of the level of their assistive torque will be provided along with a target torque level. The muscle vibrators will alternate from one side of each of the 2 joints to the other as the motion reverses, vibration always being applied to the lengthening muscles. This treatment will last 30 min in each session.
Sponsors
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Ischemic or Hemorrhagic stroke affecting the right arm * One year or longer since stroke * Severe impairment of right arm with a baseline upper extremity Fugl-Meyer score between 8-24 * Right elbow and shoulder spasticity (Ashworth score ≤3) * Right shoulder abduction-elbow flexion dyssynergia
Exclusion criteria
* Exercise intolerance * Co-morbidities limiting arm movement (e.g. shoulder subluxation) * Chronic pain * Cognitive dysfunction preventing compliance with instructions * Participation in other ongoing research studies * Plans to initiate or discontinue any physical/occupational therapy during the period of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Assessment - Upper Extremity | Baseline and change from baseline at 0 and 3 months post completion |
Secondary
| Measure | Time frame |
|---|---|
| Ashworth Spasticity Scale | Baseline and change from baseline at 0 and 3 months post completion |
| Modified Wolf Motor Test | Baseline and change from baseline at 0 and 3 months post completion |
Other
| Measure | Time frame | Description |
|---|---|---|
| Box and Block Test | Baseline and change from baseline at 0 and 3 months post completion | — |
| Upper extremity strength of the shoulder and elbow joints | Baseline, after each of 30 treatments, 3 months post completion of all treatments | The PAAD measures the strength at the elbow and shoulder by recording the torque applied by the subject to the device with the elbow and shoulder during maximal efforts. |
| Reaching Test | Baseline and change from baseline at 0 and 3 months post completion | In the Reaching Test, a video system will test each participant's pointing accuracy and smoothness of transportation of the arm to reach specific targets. |
Countries
United States
Outcome results
None listed