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slow recruitment, evolution of investigational device, differences in healthcare models affecting trial
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MindMotionPRO | Experimental | MindMotionPRO exercises in addition to standard practice for upper limb rehabilitation |
|
| Self-Directed Prescribed Exercises | Active Comparator | Self-Directed Prescribed Exercises in addition to standard practice for upper limb rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MindMotionPRO | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods | 4 weeks |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Resource utilization: time spent administrating rehabilitation exercises | therapist (physiotherapist or other medical staff) time spent administrating rehabilitation exercises | 4 weeks |
| Change from Baseline in upper extremity muscle strength measured by the Medical research Council Scale (MRC) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valeria Caso, MD | Azienda Ospedale Santa Maria della Misericordia, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schön Klinik | Bad Aibling | 83043 | Germany | |||
| Santa Maria della Misericordia Hospital |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000068079 | Motor Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Self-Directed Prescribed Exercises | Other | 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. |
|
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| 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 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 |
| 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 |
muscle strength for shoulder elevation, elbow flexion/extension, forearm pronation/supination and wrist extension/flexion |
| Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks and 16 weeks |
| Perugia |
| Umbria |
| 06129 |
| Italy |
| Queen Elisabeth University Hospital | Glasgow | G51 4TF | United Kingdom |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001523 | Mental Disorders |