Evaluation of Robotic Arm Rehabilitation in Stroke Patients

Completed

Phase N/A Results

Trial Description

The purpose of this study is to compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits.

Detailed Description

A robotic exercise device has been developed(MIT-MANUS)capable of providing therapy to the arm for patients with weakness due to stroke. The randomized trial will compare conventional care, planar robot intervention and an intervention of planar and vertical robot training among patients with chronic, stable deficits. We will evaluate motor outcomes, effectiveness, cost, patient satisfaction and quality of life. The study will determine the efficacy of upper extremity robot therapy compared to supervised self-administered exercise therapy in patients with deficits due to stroke.

Conditions

Interventions

  • Robotic Upper Extremity Neurorehabilitation Device
    Intervention Desc: Upper extremity exercise using a planar robot Upper extremity exercise using a planar and vertical robot
    ARM 1: Kind: Experimental
    Label: 1
    Description: Robot Exercise Group
    ARM 2: Kind: Experimental
    Label: Arm 1
    Description: Robot Exercise Group
  • Traditional Upper Extremity Exercise Group Other
    Intervention Desc: Upper extremity stretching, skateboard reaching activities, and arm ergometer
    ARM 1: Kind: Experimental
    Label: 2
    Description: Traditional Upper Extremity Exercise Group
    ARM 2: Kind: Experimental
    Label: Arm 2
    Description: Traditional Upper Extremity Exercise Group

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Upper Extremity Motor Performance Test The primary outcome measure is repeated at midway intervention visit 9, final intervention visit 18, and at a 12 week follow-up visit No
Primary Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment Baseline to Final Training (6 weeks) No

Sponsors