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Immersive Virtual Reality for Stroke Motor Rehabilitation

Primary Purpose

Chronic Stroke, Motor Disorders

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

MindMotion PRO

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring stroke, neurorehabilitation, virtual reality, rehabilitation dose, motor rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Center for Neuroprosthetics-Valais (EPFL) at Clinique Romande de Réadaptation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MindMotion PRO

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Change in Upper limb function assessed with Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

Secondary Outcome Measures

Change in Functional Independence Measure (FIM)

Change in kinematic metrics/goniometry (active range of motion).

Change in Modified Medical Research Council Scale (mMRCS)

Change in Visual Analog Scale (VAS) for Pain

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

Full Information

NCT ID

NCT03094650

First Posted

March 14, 2017

Last Updated

March 23, 2017

Sponsor

Mindmaze SA

Collaborators

Ecole Polytechnique Fédérale de Lausanne, Clinique Romande de Readaptation

1. Study Identification

Unique Protocol Identification Number

NCT03094650

Brief Title

Immersive Virtual Reality for Stroke Motor Rehabilitation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

February 2015 (Actual)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mindmaze SA

Collaborators

Ecole Polytechnique Fédérale de Lausanne, Clinique Romande de Readaptation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Stroke, Motor Disorders

Keywords

stroke, neurorehabilitation, virtual reality, rehabilitation dose, motor rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MindMotion PRO

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

MindMotion PRO

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task)

Description

Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task)

Time Frame

5 weeks

Title

Training intensity: number of goal-directed movements per minute of effective training time.

Description

Training intensity: number of goal-directed movements per minute of effective training time.

Time Frame

5 weeks

Title

Change in Upper limb function assessed with Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

Description

Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

Time Frame