Bilateral Training Versus Unilateral Training in Stroke

Completed

Phase 2 Results N/A

Trial Description

This randomized, single-blind study compares the effectiveness of bilateral training to unilateral training for individuals with moderate hemiparesis. We hypothesize that bilateral training will be superior to unilateral in the proximal extremity but not the distal one.

Detailed Description

Upper extremity hemiparesis is the most common post-stroke disability. Longitudinal studies have indicated that 30 to 66 percent of stroke survivors do not have full arm function six months post-stroke. Bilateral arm training has been investigated as a potential rehabilitation intervention for individuals not eligible for constraint induced movement therapy.
This training study included 24 hours of treatment over eight weeks. The protocol consisted of reaching activities with rhythmic auditory cueing emphasizing the proximal arm. Subjects assigned to the bilateral group performed bilateral symmetrical activities while subjects in the unilateral group performed the same activity with the affected arm only. The Motor Assessment Scale-Upper Limb Item and the Motor Status Scale are used as primary outcome measures. The Reaching Performance Scale and strength measures are secondary outcome measures. Assessments are administered pre-/ and post-training by a blind rater.

Conditions

Interventions

  • Bilateral upper extremity training Behavioral
    Intervention Desc: Bilateral symmetrical upper extremity training for proximal control for three hours per week for eight weeks.
    ARM 1: Kind: Experimental
    Label: 1
    Description: bilateral training
  • Unilateral upper extremity training Behavioral
    Intervention Desc: Unilateral upper extremity training for proximal extremity for three hours a week for eight weeks.
    ARM 1: Kind: Experimental
    Label: 2
    Description: Unilateral training

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Motor Assessment Scale pre and post (week one and week 8) No
Primary Motor Status Scale pre and post, Week 0 and Week eight No
Secondary Reaching Performance Scale pre and post training (Week 0 and week 8) No

Sponsors