Clinical Trial: Immersive Virtual Reality for Stroke Motor Rehabilitation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Use of Immersive Virtual Reality for Upper Limb Neurorehabilitation in Stroke Survivors

Brief Summary: The present study aims at investigating (i) the feasibility in chronic stroke of using a dedicated virtual reality (VR) based system that embeds real-time 3D motion capture and embodied visual feedback to deliver functional exercises designed for training of impaired upper limb motor skills, (ii) whether chronic stroke survivors improve in functional outcomes in the upper limb when exposed to intensive VR-based therapy, and (iii) safety and tolerance to such a technology. The investigators hypothesize that intensive VR-based rehabilitation may lead to high rehabilitation doses and functional improvement in chronic stroke.

Detailed Summary:
Sponsor: Mindmaze SA

Current Primary Outcome:

  • Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task) [ Time Frame: 5 weeks ]
    Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task)
  • Training intensity: number of goal-directed movements per minute of effective training time. [ Time Frame: 5 weeks ]
    Training intensity: number of goal-directed movements per minute of effective training time.
  • Change in Upper limb function assessed with Fugl-Meyer Assessment for Upper Extremity (FMA-UE) [ Time Frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up) ]
    Fugl-Meyer Assessment for Upper Extremity (FMA-UE)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Functional Independence Measure (FIM) [ Time Frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up) ]
  • Change in kinematic metrics/goniometry (active range of motion). [ Time Frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up) ]
  • Change in Modified Medical Research Council Scale (mMRCS) [ Time Frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up) ]
  • Change in Visual Analog Scale (VAS) for Pain [ Time Frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up) ]
  • Safety and Acceptance of Technology assessed with a questionnaire [ Time Frame: 5 weeks ]

    Participants will answer a questionnaire to evaluate following aspects:

    • Tolerance to VR intervention
    • Adverse event monitoring
    • Self-evaluation
    • Acceptance of technology
    • Motivation


Original Secondary Outcome: Same as current

Information By: Mindmaze SA

Dates:
Date Received: March 14, 2017
Date Started: February 2015
Date Completion:
Last Updated: March 23, 2017
Last Verified: March 2017