Immersive Virtual Reality for Stroke Motor Rehabilitation

Chronic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094650
• Other study ID #: MindMaze-2015-CT01
• Status: Completed
• Phase: N/A
• First received: March 14, 2017
• Last updated: March 23, 2017
• Start date: February 2015
• Est. completion date: November 2015

Study information

• Verified date: March 2017
• Source: Mindmaze SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke
• Motor Disorders
• Stroke

Intervention

Device:
• MindMotion PRO
Patients will receive five weeks of therapy with 2 sessions (minimum) per week lasting for 45-60 minutes each minimum. The training sessions are based on the MindMotion PRO's virtual reality exercises.

Locations

Country	Name	City	State
Switzerland	Center for Neuroprosthetics-Valais (EPFL) at Clinique Romande de Réadaptation	Sion	Valais

Sponsors (3)

Lead Sponsor	Collaborator
Mindmaze SA	Clinique Romande de Réadaptation CRR-Suva, École polytechnique fédérale de Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task)	Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task)	5 weeks
Primary	Training intensity: number of goal-directed movements per minute of effective training time.	Training intensity: number of goal-directed movements per minute of effective training time.	5 weeks
Primary	Change in Upper limb function assessed with Fugl-Meyer Assessment for Upper Extremity (FMA-UE)	Fugl-Meyer Assessment for Upper Extremity (FMA-UE)	At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Secondary	Change in Functional Independence Measure (FIM)		At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Secondary	Change in kinematic metrics/goniometry (active range of motion).		At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Secondary	Change in Modified Medical Research Council Scale (mMRCS)		At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Secondary	Change in Visual Analog Scale (VAS) for Pain		At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Secondary	Safety and Acceptance of Technology assessed with a questionnaire	Participants will answer a questionnaire to evaluate following aspects: Tolerance to VR intervention; Adverse event monitoring; Self-evaluation; Acceptance of technology; Motivation	5 weeks