CVA (Cerebrovascular Accident), TBI Traumatic Brain Injury
Conditions
Keywords
Virtual Reality Therapy, Upper Limb Rehabilitation, Stroke Rehabilitation, Fugl-Meyer Assessment, Neurorehabilitation, Wearable Motion Sensors
Brief summary
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.
Interventions
DEVICEMyMove/VR system
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.
DEVICEPassive VR
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.
Sponsors
Reuth Rehabilitation Hospital
6Degrees LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Time since neurological event: At least 2 weeks post-stroke or post-head injury. 2. Motor impairment: Upper extremities: Presence of hemiparesis without complete paralysis. Participants receiving rehabilitation focused on functional transfer to the contralateral hand using compensatory or adaptive motor learning strategies will also be eligible. Lower extremities: Presence of partial voluntary movement sufficient to allow participation in rehabilitation training. 3. Cognitive ability: Sufficient cognitive capacity to understand instructions and engage with VR-based training, as determined by the principal investigator and/or treating physician. 4. Medical stability: Medically stable condition allowing participation in the training. 5. Informed consent: Ability to provide written informed consent personally or via a legal guardian. 6. Final eligibility will be determined by the principal investigator/ treating physician.
Exclusion criteria
1. Severe cognitive or language impairment: Cognitive deficits or language comprehension impairments that prevent safe and meaningful participation. 2. 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. 3. Medical contraindications: * Uncontrolled epilepsy * Severe vestibular or vertigo disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment - Upper Extremity (FMA-UE) | Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Finger Tapping Test | Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up | 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. |
| Box and Blocks Test (BBT) | Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up | 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. |
| 10-Meter Walk Test (10MWT) | Immediate post-intervention (8 weeks) | 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. |
| Five Times Sit-to-Stand Test (5xSTS) | Immediate post-intervention (8 weeks) | 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. |
Countries
Israel
Contacts
CONTACTRachel Dankner, Prof.
CONTACTMarina Brozgol
Outcome results
None listed