Clinical Trial: Study Evaluating the MindMotionPRO for Early Post-stroke Upper-limb Rehabilitation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized Parallel-group Study Evaluating the Effectiveness and Cost-effectiveness of the Co-administration of MindMotionPRO Plus Standard Practice Versus Standard Practice in Early Post-stroke Upper

Brief Summary: Randomised controlled multi-centered study using MindMotionPRO, an immersive virtual reality based system for upper limb motor rehabilitation in early post-stroke patients. The study aims to evaluate the ability of MindMotionPRO technology to increase the rehabilitation dose. Effectiveness will be evaluated by validated rehabilitation performance scales. Cost-effectiveness will be assessed by the resource utilization.

Detailed Summary: The goal of the study is to show that MindMotionPRO is a tool that allows a patient to increase the amount of rehabilitation therapy performed. This study will measure the rehabilitation dose, as measured by the duration of the rehabilitation session and the number of exercises performed by the patient. The study hypothesis is that patients in the MindMotionPRO group will spend more time performing rehabilitation exercises than in the Self-Directed Prescribed exercises group. The effectiveness of the MindMotionPRO versus Self-Directed Prescribed Exercises will also be measured, based on the change in rehabilitation performance measures. The cost-effectiveness will be measured by the resource utilization, as defined by the time spent by the therapist providing the rehabilitation session.
Sponsor: Mindmaze SA

Current Primary Outcome: Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods [ Time Frame: 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of exercises performed [ Time Frame: 4 weeks ]
  • Change from Baseline in upper extremity motor function measured by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and its subscales [ Time Frame: baseline, 4 weeks, 16 weeks ]
  • Change from Baseline in upper extremity motor ability measured by the streamlined Wolf Motor Function Test (sWMFT) score [ Time Frame: baseline, 4 weeks, 16 weeks ]
  • Change from Baseline in self-care ability measured by the Barthel index (BI) [ Time Frame: baseline, 4 weeks, 16 weeks ]
  • Change from Baseline in functional independence measured by the Modified Ranking Scale (MRS) and associated disability-adjusted life year (DALY) [ Time Frame: baseline, 4 weeks, 16 weeks ]
  • Change from Baseline in the general health status as measured by the Stroke Impact scale (SIS) [ Time Frame: baseline, 4 weeks, 16 weeks ]
  • Change from Baseline in the severity of stroke symptoms as measured by the NIH stroke scale (NIHSS) [ Time Frame: baseline, 4 weeks, 16 weeks ]
  • Change from Baseline in arm function in daily activities as measured by the Motor Activity Log (MAL) [ Time Frame: baseline, 4 weeks, 16 weeks ]
  • Motivation measured by the Intrinsic Motivation Index (IMI) [ Time Frame: 1 week and 4 weeks ]


Original Secondary Outcome: Same as current

Information By: Mindmaze SA

Dates:
Date Received: February 12, 2016
Date Started: August 2016
Date Completion: November 2017
Last Updated: January 30, 2017
Last Verified: January 2017