Overview

This trial is active, not recruiting.

Condition cerebrovascular accident
Treatments electrically assisted movement therapy, usual and customary care
Sponsor Swiss Federal Institute of Technology
Collaborator Centre Hospitalier Universitaire Vaudois
Start date September 2015
End date September 2016
Trial size 12 participants
Trial identifier NCT02563886, EAMT-346/15

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Electrically Assisted Movement Therapy precedes usual and customary care.
electrically assisted movement therapy EAMT
Electrically Assisted Movement Therapy (EAMT) is an extension of conventional Constraint-Induced Movement Therapy (CIMT) for moderately-to-severely paralyzed patients. During EAMT, patients use a movement controller with the healthy hand, controlling movements generated through neuromuscular electrical stimulation of the paralyzed arm and hand. During each session three types of exercises can be performed: mobilization, games, and training for activities of daily living, all three involving proper shaping of exercise difficulty at therapist discretion. Therapy consists in 20 sessions of 45 minutes twice per day over five weeks.
usual and customary care Standard care
Usual and customary care ranges from no treatment to varying amounts of orthotics, home-based and clinic-based occupational therapy, or physiotherapy, but always excludes CIMT and EAMT. Therapy consists in 20 sessions of 45 minutes twice per day over five weeks, whenever possible, to match EAMT amount of therapy.
(Active Comparator)
Usual and customary care precedes Electrically Assisted Movement Therapy.
electrically assisted movement therapy EAMT
Electrically Assisted Movement Therapy (EAMT) is an extension of conventional Constraint-Induced Movement Therapy (CIMT) for moderately-to-severely paralyzed patients. During EAMT, patients use a movement controller with the healthy hand, controlling movements generated through neuromuscular electrical stimulation of the paralyzed arm and hand. During each session three types of exercises can be performed: mobilization, games, and training for activities of daily living, all three involving proper shaping of exercise difficulty at therapist discretion. Therapy consists in 20 sessions of 45 minutes twice per day over five weeks.
usual and customary care Standard care
Usual and customary care ranges from no treatment to varying amounts of orthotics, home-based and clinic-based occupational therapy, or physiotherapy, but always excludes CIMT and EAMT. Therapy consists in 20 sessions of 45 minutes twice per day over five weeks, whenever possible, to match EAMT amount of therapy.

Primary Outcomes

Measure
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)

Secondary Outcomes

Measure
Wolf Motor Function Test
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)
Modified Ashworth scale
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)
European stroke scale
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)
Motor Activity Log
time frame: T0 (Before treatment); at 1, 2, 3, 4, 5, 6, 18 and 30 weeks after treatment start

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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);

Additional Information

Official title Electrically Assisted Movement Therapy (EAMT) for Upper Limb Stroke Rehabilitation
Principal investigator Stefano Carda, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Swiss Federal Institute of Technology.