NCT02688413

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

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-limb Rehabilitation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Mindmaze SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Stroke
• Motor Disorders

Interventions

Type	Name	Description
DEVICE	MindMotionPRO	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.
OTHER	Self-Directed Prescribed Exercises	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.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-08-01
• Completion: 2018-02-01
• First posted: 2016-02-23
• Last updated: 2018-03-22

Locations

3 sites across 3 countries: Germany, Italy, United Kingdom