Immersive Virtual Reality for Stroke Motor Rehabilitation

Not Applicable

Completed

• Conditions: Chronic Stroke; Motor Disorders
• Interventions: Device: MindMotion PRO

• Registration Number: NCT03094650
• Lead Sponsor: Mindmaze SA

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 Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Status Verified: 2017-03
• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-23
• Last Update Submitted: 2017-03-23
• Study First Posted: 2017-03-29
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Ischemic or hemorrhagic minor-to-moderate (0<NIHSS<16) stroke with hemiparesis and experiencing arm motor difficulties
• At least 6 months after stroke incident
• Maximum 4 on the Medical Research Council Scale (MRCS) for shoulder elevation and elbow flexion/extension
• 18 years and older
• First ever stroke

Exclusion Criteria

• Participating in another movement treatment study at the time of the present study
• Severe cognitive impairment (Mini Mental Status Examination score < 18 points)
• Orthopedic impairment or visual disorders limiting the treatment
• Unable to give informed consent form
• Risk of epileptic seizures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MindMotion PRO	MindMotion PRO	The training sessions consist of virtual reality based rehabilitation exercises using the MindMotion PRO device.

Primary Outcome Measures

Name	Time	Method
Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task)	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.	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)	At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)	Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

Secondary Outcome Measures

Name	Time	Method
Change in Modified Medical Research Council Scale (mMRCS)	At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Change in Functional Independence Measure (FIM)	At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Change in Visual Analog Scale (VAS) for Pain	At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Change in kinematic metrics/goniometry (active range of motion).	At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Safety and Acceptance of Technology assessed with a questionnaire	5 weeks	Participants will answer a questionnaire to evaluate following aspects: * Tolerance to VR intervention; * Adverse event monitoring; * Self-evaluation; * Acceptance of technology; * Motivation

Trial Locations

Locations (1)

Center for Neuroprosthetics-Valais (EPFL) at Clinique Romande de Réadaptation; 🇨🇭 Sion, Valais, Switzerland