Electrically Assisted Movement Therapy (EAMT)

Federal Institute of Technology (ETH) Zurich

Status: Unknown

Conditions: Cerebrovascular Accident

Treatments: Other: Usual and customary care; Other: Electrically Assisted Movement Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02563886

EAMT-346/15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 2 patient groups

EAMT, then standard care

Experimental group

Description:

Electrically Assisted Movement Therapy precedes usual and customary care.

Treatment:

Other: Electrically Assisted Movement Therapy

Other: Usual and customary care

Standard care, then EAMT

Active Comparator group

Description:

Usual and customary care precedes Electrically Assisted Movement Therapy.

Treatment:

Other: Electrically Assisted Movement Therapy

Other: Usual and customary care