Electrically Assisted Movement Therapy "EAMT"

Active, not recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Usual and Customary Care Other
    Other Names: Standard care
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: EAMT, then standard care
    Description: Electrically Assisted Movement Therapy precedes usual and customary care.
    ARM 2: Kind: Experimental
    Label: Standard care, then EAMT
    Description: Usual and customary care precedes Electrically Assisted Movement Therapy.
  • Electrically Assisted Movement Therapy Other
    Other Names: EAMT
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: EAMT, then standard care
    Description: Electrically Assisted Movement Therapy precedes usual and customary care.
    ARM 2: Kind: Experimental
    Label: Standard care, then EAMT
    Description: Usual and customary care precedes Electrically Assisted Movement Therapy.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary Motor Activity Log T0 (Before treatment); at 1, 2, 3, 4, 5, 6, 18 and 30 weeks after treatment start No

Sponsors