Electrically Assisted Movement Therapy (EAMT) for Upper Limb Stroke Rehabilitation

Electrically Assisted Movement Therapy

Sponsors

Lead sponsor: Swiss Federal Institute of Technology

Collaborator: Centre Hospitalier Universitaire Vaudois
Swiss Commission for Technology and Innovation

Source Swiss Federal Institute of Technology
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.

Overall Status Unknown status
Start Date September 2015
Completion Date December 2016
Primary Completion Date September 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE), 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 Outcome
Measure Time Frame
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)
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)
Motor Activity Log T0 (Before treatment); at 1, 2, 3, 4, 5, 6, 18 and 30 weeks after treatment start
Enrollment 12
Condition
Intervention

Intervention type: Other

Intervention name: Electrically Assisted Movement Therapy

Description: 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.

Other name: EAMT

Intervention type: Other

Intervention name: Usual and customary care

Description: 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.

Other name: Standard care

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);

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Location
facility Service de Neuropsychologie et neuroréhabilitation - CHUV
Location Countries

Switzerland

Verification Date

February 2016

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Centre Hospitalier Universitaire Vaudois

Investigator full name: Stefano Carda

Investigator title: MD, PhD

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: EAMT, then standard care

Arm group type: Experimental

Description: Electrically Assisted Movement Therapy precedes usual and customary care.

Arm group label: Standard care, then EAMT

Arm group type: Active Comparator

Description: Usual and customary care precedes Electrically Assisted Movement Therapy.

Acronym EAMT
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov