Evaluation of a Wearable Exoskeleton for Functional Arm Training

Active, not recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is to investigate how the cable-driven arm exoskeleton (CAREX) can assist task performance during 3D arm movement tasks under various experimental conditions in healthy individuals and patients with stroke. This study is designed to test motor learning with the robotic rehabilitative device CAREX under three conditions in healthy subjects and subjects with post-stroke hemiparesis.

Conditions

Interventions

  • Gravity Elimination Alone Other
    Intervention Desc: CAREX will compensate for the gravity of the subject's arm, i.e. subject can move their arm to a specific position and relax all the arm muscles, CAREX will hold the arm in that configuration
    ARM 1: Kind: Experimental
    Label: Healthy Subjects
    Description: Seven healthy patients will serve as controls based on preliminary data in healthy volunteers using CAREX with gravity elimination alone versus gravity elimination plus path assistance.
    ARM 2: Kind: Experimental
    Label: Chronic Post Stroke Right Side Hemiparesis
    Description: Radiologically verified unilateral stroke patients with at least 4 months previously.
  • Path Assistance Alone Other
    Intervention Desc: CAREX will push subject's arm to a pre-specified path. If the arm is not in the path, CAREX will generate some force that is proportional to the distance between the hand and the path. The subject will feel like having a spring connected between his hand and the path
    ARM 1: Kind: Experimental
    Label: Healthy Subjects
    Description: Seven healthy patients will serve as controls based on preliminary data in healthy volunteers using CAREX with gravity elimination alone versus gravity elimination plus path assistance.
    ARM 2: Kind: Experimental
    Label: Chronic Post Stroke Right Side Hemiparesis
    Description: Radiologically verified unilateral stroke patients with at least 4 months previously.
  • Path Assistance and Gravity Elimination Other
    ARM 1: Kind: Experimental
    Label: Healthy Subjects
    Description: Seven healthy patients will serve as controls based on preliminary data in healthy volunteers using CAREX with gravity elimination alone versus gravity elimination plus path assistance.
    ARM 2: Kind: Experimental
    Label: Chronic Post Stroke Right Side Hemiparesis
    Description: Radiologically verified unilateral stroke patients with at least 4 months previously.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Supportive Care
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Passive range of motion measured by goniometry 1 Day No
Primary Active range of motion measured by goniometry 1 Day No
Primary Upper extremity motor impairment measured by performance on the 33 tasks of the Fugl-Meyer Scale (FMS) 1 Day No
Primary Spasticity measured by the Modified Ashworth Scale (MAS) 1 Day No

Sponsors