Study Evaluating the MindMotionPRO for Early Post-stroke Upper-limb Rehabilitation "MOVE-Rehab"

Terminated

Phase N/A Results N/A

Trial Description

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 Description

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.

Trial Stopped: slow recruitment, evolution of investigational device and differences in healthcare models affecting study

Conditions

Interventions

  • MindMotionPRO Device
    Intervention Desc: The MindMotionPRO, a certified device for medical use, is a virtual reality based system to train upper limb activities in a game scenario. The participant will receive 5 exercises sessions with the MindMotionPRO per week over 4 weeks. This is done in addition to standard practice for upper limb rehabilitation which should be at least 30 min five times per week.
    ARM 1: Kind: Experimental
    Label: MindMotionPRO
    Description: MindMotionPRO exercises in addition to standard practice for upper limb rehabilitation
  • Self-Directed Prescribed Exercises Other
    Other Names: Graded Repetitive Arm Supplementary Program (GRASP)
    Intervention Desc: GRASP is an arm and hand exercise program for stroke patients, designed to supplement standard rehabilitation therapies. The participant will receive 5 GRASP exercises sessions per week over 4 weeks. This is done in addition to standard practice for upper limb rehabilitation which should be at least 30 min five times per week.
    ARM 1: Kind: Experimental
    Label: Self-Directed Prescribed Exercises
    Description: Self-Directed Prescribed Exercises in addition to standard practice for upper limb rehabilitation

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods 4 weeks No
Secondary Number of exercises performed 4 weeks No
Secondary Change from Baseline in upper extremity motor function measured by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and its subscales baseline, 4 weeks, 16 weeks No
Secondary Change from Baseline in upper extremity motor ability measured by the streamlined Wolf Motor Function Test (sWMFT) score baseline, 4 weeks, 16 weeks No
Secondary Change from Baseline in self-care ability measured by the Barthel index (BI) baseline, 4 weeks, 16 weeks No
Secondary Change from Baseline in functional independence measured by the Modified Ranking Scale (MRS) and associated disability-adjusted life year (DALY) baseline, 4 weeks, 16 weeks No
Secondary Change from Baseline in the general health status as measured by the Stroke Impact scale (SIS) baseline, 4 weeks, 16 weeks No
Secondary Change from Baseline in the severity of stroke symptoms as measured by the NIH stroke scale (NIHSS) baseline, 4 weeks, 16 weeks No
Secondary Change from Baseline in arm function in daily activities as measured by the Motor Activity Log (MAL) baseline, 4 weeks, 16 weeks No
Secondary Motivation measured by the Intrinsic Motivation Index (IMI) 1 week and 4 weeks No

Sponsors