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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

TypeNameDescription
BEHAVIORALBilateral movements and neuromuscular electrical stimulationParticipants 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.
BEHAVIORALBilateral movements and neuromuscular electrical stimulationParticipants 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.
BEHAVIORALBilateral movements and sham electrical stimulationParticipants 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.