Phase 2
N=30
Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments
Cerebrovascular Accident · Hemiplegia
Bottom Line
View on ClinicalTrials.gov: NCT00369668 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Box and Block Test; Data Collected = Number of Blocks Moved — 24.5; 24.6; 40; 27.5 Blocks — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bilateral movements and neuromuscular electrical stimulation (Behavioral); Bilateral movements and sham electrical stimulation (Behavioral)
- Age
- Adult, Older Adult · 44+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Box and Block Test; Data Collected = Number of Blocks Moved |
24.5; 24.6; 40; 27.5; 31.8; 42 | <0.05 sig |
| PRIMARY Fugl-Meyer Upper Extremity Motor Test |
39; 41; 53; 42; 45; 56 | — |
| PRIMARY Fractionated Reaction Time |
179; 225; 135; 170; 241; 161 | — |
Summary
The purpose of this study was to determine the effect of two amounts of treatment therapy on post stroke motor recovery in the arms. The therapy is bilateral movement training combined with electrical stimulation on the impaired limb.
Eligibility Criteria
Inclusion Criteria
- an ability to complete 10º of wrist or finger extension from a 60 - 65 º flexed position
- score less than a 56 on the UE subscale of the Fugl-Meyer Assessment
- an ability to voluntarily activate slight movements in the wrist and fingers so that the EMG activity reaches a minimal level on the microprocessor for electrical stimulation to be activated
- unilateral, first stroke of ischemic or hemorrhagic origin in the carotid artery distribution
- free of major post stroke complications
- able to attend therapy 2 days/week or 4 days/week for 2 weeks
- score at least a 16 on the Mini Mental Status Examination
- able to discriminate sharp from dull and light touch using traditional sensation tests.
Exclusion Criteria
- hemiparetic arm is insensate
- motor impairments from stroke on opposite side of body
- pre-existing neurological disorders such as Parkinson's disease, Multiple Sclerosis, or dementia
- Legal blindness or severe visual impairment; 5) Life expectancy less than one year
- Severe arthritis or orthopedic problems that limit passive ranges of motion of upper extremity (passive finger extension < 40º; passive wrist extension < 40º; passive elbow extension <40º; shoulder flexion/abduction < 80º)
- History of sustained alcoholism or drug abuse in the last six months
- Has pacemaker or other implanted device
- pregnant
Data sourced from ClinicalTrials.gov (NCT00369668). 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.