Chronic Stroke, Motor Disorders
Conditions
Keywords
stroke, neurorehabilitation, virtual reality, rehabilitation dose, motor rehabilitation
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.
Interventions
DEVICEMindMotion 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.
Sponsors
Ecole Polytechnique Fédérale de Lausanne
Clinique Romande de Readaptation
Mindmaze SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale (VAS) for Pain | 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) | — |
| 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 |
| Change in kinematic metrics/goniometry (active range of motion). | At baseline, 5 weeks (post intervention) and 9 weeks (follow-up) | — |
| Change in Modified Medical Research Council Scale (mMRCS) | At baseline, 5 weeks (post intervention) and 9 weeks (follow-up) | — |
Countries
Switzerland
Outcome results
None listed