NCT00565045

Treatments for Recovery of Hand Function in Acute Stroke Survivors

Contralaterally Controlled Functional Electrical Stimulation for Hemiparetic Hand

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: MetroHealth Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Impaired hand function is one of the most frequently persisting consequences of stroke. The purpose of this study is to investigate whether two different types of treatment improve recovery of hand function after stroke.

Detailed description

Loss of hand function is common after stroke. Previous research suggests that treatments that focus on movement of both hands at the same time or treatments that electrically stimulate the paretic (weak) hand muscles may help the recovery of hand function after stroke. In this study, two electrical stimulation treatments will be compared in their effectiveness in restoring hand movement and hand function. One of the treatments is stimulation only, and the other is stimulation linked to movement of the contralateral hand. Study participants will be stroke survivors who are enrolled while they are still within their first 6 months after their stroke. After enrolling, their hand movement and function will be tested. Then they will be randomly assigned to one of the two treatments. Each treatment will last 6 weeks. The treatment will require the participant to perform specific exercises at home for a total of 2 hours every day and to come to the laboratory twice a week for study-related occupational therapy. At the end of the 6-week treatment, tests of hand movement and hand function will be repeated. The same tests will be repeated again at 1 and 3 months after the end of treatment to see if the effects of the treatment persist as time goes on. Changes in upper extremity impairment and activity limitation will be compared across treatment groups.

Conditions

• Stroke, Acute
• Stroke
• Hemiparesis
• Hemiplegia

Interventions

Type	Name	Description
DEVICE	Neuromuscular electrical stimulator	Intervention Characteristics Common to Both Groups • 6-week intervention 1. Home "exercise", daily 1. Exercise (at home) 2 sessions/day 2. A "session" consists of 3 (for CCFES) or 4 (for cNMES) 15-min sets separated by 5 min rest 3. A "set" entails hand opening, closing, and relaxing in response or synchrony to light and sound cues and according to group-specific instructions 2. Lab "therapy", 2x/week 1. Two 1.5-hr sessions/week, working on functional hand tasks and tracking task (if possible).

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2007-11-29
• Last updated: 2018-12-19
• Results posted: 2013-07-10

Locations

1 site across 1 country: United States