Efficacy and Safety of 6Degrees MyMove Interactive Virtual Reality Compared to Passive Virtual Reality in Subacute Stroke and Traumatic Brain Injury Rehabilitation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Time since neurological event: At least 2 weeks post-stroke or post-head injury.
- •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.
- •Cognitive ability: Sufficient cognitive capacity to understand instructions and engage with VR-based training, as determined by the principal investigator and/or treating physician.
- •Medical stability: Medically stable condition allowing participation in the training.
- •Informed consent: Ability to provide written informed consent personally or via a legal guardian.
- •Final eligibility will be determined by the principal investigator/ treating physician.
排除标准
- •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:
- •Uncontrolled epilepsy
- •Severe vestibular or vertigo disorders
研究组 & 干预措施
MyMove/VR system
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.
干预措施: MyMove/VR system (Device)
Passive VR
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.
干预措施: Passive VR (Device)
结局指标
主要结局
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
时间窗: 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.
次要结局
- Finger Tapping Test(Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up)
- Box and Blocks Test (BBT)(Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up)
- 10-Meter Walk Test (10MWT)(Immediate post-intervention (8 weeks))
- Five Times Sit-to-Stand Test (5xSTS)(Immediate post-intervention (8 weeks))