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| Name | Class |
|---|---|
| 6Degrees LTD | INDUSTRY |
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Stroke and traumatic brain injury frequently result in persistent upper and lower limb motor impairment. While conventional rehabilitation improves outcomes, patient adherence and training intensity remain limiting factors. Immersive virtual reality (VR)-based therapy may enhance neuroplasticity by delivering high-intensity, task-oriented motor practice with enriched sensory feedback.
This randomized controlled trial evaluates the efficacy and safety of the 6Degrees MyMove interactive VR system compared to passive VR exposure in individuals undergoing subacute inpatient rehabilitation after stroke or traumatic brain injury. Sixty participants will be randomized 1:1 to receive either interactive VR-based motor training or passive VR viewing, in addition to standard rehabilitation care, three times weekly for eight weeks.
The primary objective is to determine whether interactive VR leads to greater improvement in motor function compared to passive VR. Secondary outcomes include dexterity, gait speed, functional independence, psychological status, adherence, usability, and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyMove/VR system | Experimental | The treatment system consists of two lightweight MyMove bands and Virtual-Reality (VR) gear. Proprietary software and content allow tracking of performance in real-time, with feedback to both the patient and treating - personnel. |
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| Passive VR | Active Comparator | Passive VR involves the use of a head-mounted display to present immersive audiovisual content (e.g., movies, 360-degree videos, or virtual environments) without requiring active engagement, task performance, or interaction with the virtual environment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyMove/VR system | Device | During each session, participants will engage in goal-directed motor exercises within an immersive VR environment delivered through a head-mounted display. Tasks are designed to promote range of motion, coordination, motor control, and functional movement. The system provides real-time visual and auditory feedback and adapts task difficulty based on individual performance and motor capacity. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment - Upper Extremity (FMA-UE) | A standardized, stroke-specific measure of upper-limb motor impairment assessing movement, coordination, and reflex activity. Scores range from 0 to 66, with higher scores indicating better motor function. | Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Finger Tapping Test | A performance-based assessment of upper-limb motor speed and neuromotor control. Participants are instructed to tap a key or surface as rapidly as possible with the index finger over a fixed time interval. The total number of taps is recorded, with higher scores reflecting better motor speed and coordination. | Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D-5L | A widely used, validated patient-reported measure of health-related quality of life assessing five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on five levels of severity (no problems to extreme problems). Responses are converted into a health utility index score, typically ranging from values below 0 (worse than death) to 1 (perfect health), with higher scores indicating better health status. An accompanying visual analog scale (EQ-VAS; 0-100) captures participants' self-rated overall health. |
Inclusion Criteria:
Exclusion Criteria:
Severe cognitive or language impairment: Cognitive deficits or language comprehension impairments that prevent safe and meaningful participation.
Neurological deficits interfering with VR: Severe hemispatial neglect or visual field deficits that interfere with VR use. Moderate neglect may be permitted at the investigator's discretion.
Medical contraindications:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Dankner, Prof. | Contact | +972-3-6383610 | rachel.dankner@reuth.org.il | |
| Marina Brozgol | Contact | +972-3-6383610 | marina.brozgol@reuth.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reuth Rehabilitation Hospital - Tel Aviv | Tel Aviv | 6772830 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38437102 | Background | Curiel RC, Nakamura T, Kuzuoka H, Kanaya T, Prahm C, Matsumoto K. Virtual Reality Self Co-Embodiment: An Alternative to Mirror Therapy for Post-Stroke Upper Limb Rehabilitation. IEEE Trans Vis Comput Graph. 2024 May;30(5):2390-2399. doi: 10.1109/TVCG.2024.3372035. Epub 2024 Apr 19. | |
| 41270979 | Background | Ciullo G, Bozzetti F, Ziccarelli S, Fogassi L, Errante A. Neurophysiological mechanisms underlying action observation treatment for upper limb stroke rehabilitation: A mini-review. Neurosci Biobehav Rev. 2026 Jan;180:106484. doi: 10.1016/j.neubiorev.2025.106484. Epub 2025 Nov 19. |
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| Passive VR | Device | Participants in the control arm will receive immersive virtual reality exposure using a head-mounted display. The content will include movies, 360-degree videos, or virtual environments designed to provide audiovisual immersion without requiring active motor engagement or task performance. |
|
| Box and Blocks Test (BBT) | A standardized measure of gross manual dexterity in which participants are instructed to transfer as many blocks as possible, one at a time, from one compartment of a box to another within 60 seconds. The total number of blocks successfully transferred is recorded. Higher scores indicate better manual dexterity. | Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up |
| 10-Meter Walk Test (10MWT) | A performance-based measure of gait speed in which participants are instructed to walk a distance of 10 meters at a comfortable and safe pace. Walking speed is calculated in meters per second (m/s). Higher gait speed values indicate better functional mobility. | Immediate post-intervention (8 weeks) |
| Five Times Sit-to-Stand Test (5xSTS) | A performance-based measure of lower-limb strength and functional mobility in which participants are instructed to rise from a seated position to standing and return to sitting five consecutive times as quickly and safely as possible. The total time required to complete the task is recorded in seconds. Lower completion times indicate better lower-limb function. | Immediate post-intervention (8 weeks) |
| Immediate post-intervention (8 weeks) |
| System Usability Scale (SUS) | A 10-item questionnaire assessing perceived usability of a system or technology. Each item is rated on a 5-point Likert scale (strongly disagree to strongly agree). Responses are converted to a total score ranging from 0 to 100, with higher scores indicating better perceived usability. | Immediate post-intervention (8 weeks) |
| 37745019 | Background | Bargeri S, Scalea S, Agosta F, Banfi G, Corbetta D, Filippi M, Sarasso E, Turolla A, Castellini G, Gianola S. Effectiveness and safety of virtual reality rehabilitation after stroke: an overview of systematic reviews. EClinicalMedicine. 2023 Sep 14;64:102220. doi: 10.1016/j.eclinm.2023.102220. eCollection 2023 Oct. |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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