Electrically Assisted Movement Therapy

Cerebrovascular Accident Clinical Trial

— EAMT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02563886
• Other study ID #: EAMT-346/15
• Status: Active, not recruiting
• Phase: N/A
• First received: September 22, 2015
• Last updated: February 23, 2016
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: February 2016
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Cantonal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Other:
• Electrically Assisted Movement Therapy
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
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.

Locations

Country	Name	City	State
Switzerland	Service de Neuropsychologie et neuroréhabilitation - CHUV	Lausanne	VD

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Centre Hospitalier Universitaire Vaudois, Swiss Commission for Technology and Innovation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE),	A quantitative measure of motor impairment.	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)	No
Secondary	Wolf Motor Function Test	Quality and time of task performance	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)	No
Secondary	Modified Ashworth scale	A quantitative measure of hand and arm spasticity	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)	No
Secondary	European stroke scale	Overall functional status	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)	No
Secondary	Motor Activity Log	Semi-structured interview to assess arm function.	T0 (Before treatment); at 1, 2, 3, 4, 5, 6, 18 and 30 weeks after treatment start	No