Electrically Assisted Movement Therapy (EAMT) for Upper Limb Stroke Rehabilitation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cerebrovascular Accident
- Sponsor
- Swiss Federal Institute of Technology
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE),
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to determine whether intensive, focused training of the affected upper extremity after stroke results in long-term functional gains in moderately-to-severely paralyzed patients, more than 6 months after their vascular accident. During the course of therapy, user's attempts to move and complete exercises are assisted by neuromuscular electrical stimulation.
Detailed Description
This pilot study quantifies functional gains induced by the Electrically Assisted Movement Therapy (EAMT), an extension of Constraint-Induced Movement Therapy to moderately-to-severely paralyzed patients in their stable plateau phase of recovery. During EAMT, patients can assist affected upper limb movements through functional electrical stimulation. Initially, patients are divided in two groups. One of the groups receives EAMT, the other receives the best possible physical and occupational therapy. Therapy consists in 40 sessions of 45 minutes twice per day over five weeks, including a one-week therapy break. After 20 sessions, group allocation is crossed-over, and patients don't receive any therapy for one week.
Investigators
Stefano Carda
MD, PhD
Centre Hospitalier Universitaire Vaudois
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of one, first ever stroke (both ischemic or hemorrhagic) verified by brain imaging (MRI or CT);
- •Chronic impairment after stroke (minimum 6 months);
- •No contraindications to MRI;
- •No contraindications to electrical stimulation;
Exclusion Criteria
- •Unstable recovery stage (difference between two examinations \> 1 FMA-UE point);
- •Mild impairment of the upper extremity (FMA-UE \>= 21);
- •Excessive spasticity of the affected arm (modified Ashworth Scale \> 2);
Outcomes
Primary Outcomes
Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE),
Time Frame: T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment)
A quantitative measure of motor impairment.
Secondary Outcomes
- Wolf Motor Function Test(T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment))
- Motor Activity Log(T0 (Before treatment); at 1, 2, 3, 4, 5, 6, 18 and 30 weeks after treatment start)
- Modified Ashworth scale(T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment))
- European stroke scale(T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment))