Electrically Assisted Movement Therapy

Not Applicable

• Conditions: Cerebrovascular Accident
• Interventions: Other: Electrically Assisted Movement Therapy; Other: Usual and customary care

• Registration Number: NCT02563886
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24
• Primary Completion: 2016-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
EAMT, then standard care	Electrically Assisted Movement Therapy	Electrically Assisted Movement Therapy precedes usual and customary care.
EAMT, then standard care	Usual and customary care	Electrically Assisted Movement Therapy precedes usual and customary care.
Standard care, then EAMT	Usual and customary care	Usual and customary care precedes Electrically Assisted Movement Therapy.
Standard care, then EAMT	Electrically Assisted Movement Therapy	Usual and customary care precedes Electrically Assisted Movement Therapy.

Primary Outcome Measures

Name	Time	Method
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)	A quantitative measure of motor impairment.

Secondary Outcome Measures

Name	Time	Method
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)	Quality and time of task performance
Motor Activity Log	T0 (Before treatment); at 1, 2, 3, 4, 5, 6, 18 and 30 weeks after treatment start	Semi-structured interview to assess arm function.
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)	A quantitative measure of hand and arm spasticity
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)	Overall functional status

Trial Locations

Locations (1)

Service de Neuropsychologie et neuroréhabilitation - CHUV; 🇨🇭 Lausanne, VD, Switzerland