Domiciliary VR Rehabilitation

Completed

Phase N/A Results N/A

Trial Description

The purpose of this study is to determine whether domiciliary VR-based telerehabilitation is superior than domiciliary occupational therapy for inducing functional gains, enhancing corticospinal excitability, and cortical reorganization.

Conditions

Interventions

  • Domiciliary VR-based motor rehabilitation Behavioral
    Intervention Desc: 3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.
    ARM 1: Kind: Experimental
    Label: VR-based therapy
    Description: 3 weeks of home-based treatment for motor training using a virtual reality rehabilitation setup.
  • Domiciliary occupational therapy for motor rehabilitation Behavioral
    Intervention Desc: 3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.
    ARM 1: Kind: Experimental
    Label: Control
    Description: 3 weeks of home-based occupational therapy for motor training.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in motor function for activities of daily living as measured by Chedoke Arm Hand Inventory clinical At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No
Secondary Change in depression as measured by the Hamilton scale At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No
Secondary Change in motor function as measured by the Medical Research Council scale At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No
Secondary Change in spasticity for the upper arms as measured by the Ashworth scale At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No
Secondary Change in cognitive function as measured by the Mini-mental State Evaluation test At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No
Secondary Change in Grip Force as measured by a grip dynamometer At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No
Secondary Change in shoulder pain as measured by the Visual Analog Assessment scale At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No
Secondary Change in motor function as measured by the upper extremity Fugl-Meyer Assessment At baseline, at 3-weeks (after intervention), and at 12-weeks follow-up. No

Sponsors