Trials / Completed
CompletedNCT00369668
Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments
Subacute Stroke Recovery (Upper Extremity Motor Function): Bimanual Coordination Training
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of Florida · Academic / Other
- Sex
- All
- Age
- 44 Years – 86 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Intense movement training (practice) with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplasticity changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. The current compared the effects on motor function impairments for three bilateral movement groups involving two doses of treatment (i.e., bilateral training coupled with neuromuscular electrical stimulation) and a sham control. During the subacute recovery phase (3 - 6 months), patients who meet motor capabilities criteria will be randomly assigned to one of three groups: (a) low intensity: 90 minutes/session, 2 sessions/week 2 weeks; bilateral movement training coupled with active neuromuscular stimulation on the impaired wrist/fingers; (b) high intensity: 90 minutes/session, 4 sessions/week for 2 weeks; bilateral movement training coupled with active stimulation on the impaired wrist/finger extensors; and (c) control group (sham active stimulation). Patients' UE motor capabilities were assessed before treatment therapy began (pretest) and within the first week after the treatment therapy ended (posttest).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Bilateral movements and neuromuscular electrical stimulation | Participants practice moving their paretic arm at the same time as they move their non-paretic arm in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 4 times per week for 2 weeks. |
| BEHAVIORAL | Bilateral movements and neuromuscular electrical stimulation | Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 2 times per week for 2 weeks. |
| BEHAVIORAL | Bilateral movements and sham electrical stimulation | Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Sham electrical stimulation (low level electrical stimulation that can be felt but is insufficient to trigger a muscle contraction) is provided to the paretic arm during the movement. Training period was 2 times per week for 2 weeks. |
Timeline
- Start date
- 2006-08-01
- Primary completion
- 2009-06-01
- Completion
- 2009-06-01
- First posted
- 2006-08-29
- Last updated
- 2012-06-15
- Results posted
- 2012-05-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00369668. Inclusion in this directory is not an endorsement.