Motor Disorders, Stroke
Conditions
Keywords
Virtual reality, Stroke, Neurorehabilitation, Upper-limb rehabilitation, Training games
Brief 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.
Interventions
DEVICEMindMotionPRO
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.
OTHERSelf-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.
Sponsors
Mindmaze SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male/female \> 18 years old * First ever unilateral supratentorial ischemic stroke with contralateral upper extremity weakness * 1 to 6 weeks post-stroke * Able to give informed consent * Not participating any other intervention studies * Experiencing motor difficulties in using the paretic arm, with a FMA-UE score in the range of 20 to 40 out of 66 * Stroke severity with NIHSS score between 5 (mild) and 14 (moderate) out of 42 * The participant is expected to remain available (geographically stable) for 4 months after enrolment.
Exclusion criteria
* Any medical condition compromising the safety or the ability to take part to the study (such as insufficient vision or hearing, inability to participate to therapy session, inability to communicate, upper limb condition not linked to stroke, uncontrolled blood pressure, uncontrolled diabetes, co-morbidity) * Recurrent and moderate to high upper limb pain limiting delivery of rehabilitation dose * History of more than one epileptic seizures since stroke onset or uncontrolled epileptic seizure * Mild to severe cognitive impairment (Mini mental state exam (MMSE) score \< 24/30) * Depression (Hospital Anxiety and Depression Scale \> 8/21) * Moderate to severe hemispatial neglect compromising the ability to take part to the study, as determined by the Bells tests (\> 6 errors) * Brain stem stroke
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of exercises performed | 4 weeks |
| Change from Baseline in upper extremity motor function measured by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and its subscales | baseline, 4 weeks, 16 weeks |
| Change from Baseline in upper extremity motor ability measured by the streamlined Wolf Motor Function Test (sWMFT) score | baseline, 4 weeks, 16 weeks |
| Change from Baseline in self-care ability measured by the Barthel index (BI) | baseline, 4 weeks, 16 weeks |
| Change from Baseline in functional independence measured by the Modified Ranking Scale (MRS) and associated disability-adjusted life year (DALY) | baseline, 4 weeks, 16 weeks |
| Change from Baseline in arm function in daily activities as measured by the Motor Activity Log (MAL) | baseline, 4 weeks, 16 weeks |
| Motivation measured by the Intrinsic Motivation Index (IMI) | 1 week and 4 weeks |
| Change from Baseline in the general health status as measured by the Stroke Impact scale (SIS) | baseline, 4 weeks, 16 weeks |
| Change from Baseline in the severity of stroke symptoms as measured by the NIH stroke scale (NIHSS) | baseline, 4 weeks, 16 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Resource utilization: time spent administrating rehabilitation exercises | 4 weeks | therapist (physiotherapist or other medical staff) time spent administrating rehabilitation exercises |
| Change from Baseline in upper extremity muscle strength measured by the Medical research Council Scale (MRC) | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks and 16 weeks | muscle strength for shoulder elevation, elbow flexion/extension, forearm pronation/supination and wrist extension/flexion |
Countries
Germany, Italy, United Kingdom
Outcome results
None listed