N/A
N=36
Enhancing Plasticity in Stroke Patients With Severe Motor Deficit
Stroke · Cerebrovascular Accident
Bottom Line
View on ClinicalTrials.gov: NCT02633215 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Change in Fugl Meyer Assessment Motor Score — 7.4; 3.4; 7.2; 2.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- S88 Dual Output Stimulator by Grass Technologies (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Lumy Sawaki
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fugl Meyer Assessment Motor Score |
7.4; 3.4; 7.2; 2.8 | — |
| SECONDARY Change in Action Arm Research Test (ARAT) |
6.4; 2.3; 6.9; 2.4 | — |
| SECONDARY Change in Wolf Motor Function Test (WMFT) |
-0.18; -0.06; -0.14; -0.07 | — |
Summary
This study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training, to improve hand motor function in poorly recovered stroke patients. The central hypothesis is that stroke patients with severe motor deficit receiving hand nerve stimulation and intensive task-oriented therapy will have improved motor function compared to patients receiving sham nerve stimulation and task-oriented therapy.
Eligibility Criteria
Inclusion Criteria
- Chronic stroke patients
- Single stroke
- Chronic (more than 12 months after from stroke)
- At least 21 years old, but there is no upper age range for this project.
- Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.
Exclusion Criteria
- History of carpal tunnel syndrome and conditions that commonly cause peripheral neuropathy, including diabetes, uremia, or associated nutritional deficiencies
- History of head injury with loss of consciousness, severe alcohol or drug abuse, psychiatric illness
- Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery
- Cognitive deficit severe enough to preclude informed consent
- Positive pregnancy test or being of childbearing age and not using appropriate contraception
- Participants with history of untreated depression.
Data sourced from ClinicalTrials.gov (NCT02633215). 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.