Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy

Completed

Phase 2/3 Results N/A

Trial Description

The goal of this study is to determine whether task-oriented, robot-aided therapy is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in chronic hemiparetic stroke patients.

Detailed Description

Robotic therapy will be performed with ARMin, which is a robotic arm exoskeleton that permits 3D movements of both proximal and distal arm joints. Combined with an audiovisual display, this device allows virtual training of Activities of Daily Living (ADL) and therapeutic gaming. A patient-responsive controller enables the assistance of the device only as needed. Chronic stroke patients (>6 months post stroke) will be randomly assigned to either an experimental or a control group. The experimental group will perform task-related intensive therapy with the support of ARMin. Therapists will treat the patients of the control group with standard motor relearning therapy.

Conditions

Interventions

  • Robot therapy (ARMin) Device
    Intervention Desc: therapy of the affected arm with a robot for eight weeks, three times weekly for one hour
    ARM 1: Kind: Experimental
    Label: 1
  • Conventional therapy Other
    Intervention Desc: physical and occupational therapy of the affected arm for eight weeks, three times weekly for one hour
    ARM 1: Kind: Experimental
    Label: 2

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl Meyer Assessment Scale four and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up No
Secondary Wolf Motor Function Test, Stroke Impact Scale, Motor Activity Log, modified Ashworth Scale, abnormal joint synergies, active range of motion (ROM), muscle strength, and spatial precision of hand positioning. three and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up No
Secondary fMRI before and after 8 weeks therapy, 2-months follow-up No

Sponsors