Immersive Virtual Reality and Noninvasive Spinal Stimulation to Promote Arm Function in Individuals With Tetraplegia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in medical status
研究概览
简要总结
The main objective of our work is to develop and test the safety and feasibility of a home-based upper limb rehabilitation program for individuals with tetraplegia. The program will consist of simultaneous non-invasive spinal cord stimulation and immersive virtual exercises of the upper limbs, with a focus on shoulder and elbow function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •incomplete low tetraplegia (C5-8; [ASIA] classification B-D),
- •free of contraindications to transspinal stimulation,
- •more than one-year post-injury,
- •stable medication regimen for the past month,
- •utilization of wheelchair as a primary mode of mobility (>75% of the time). -
排除标准
- •Neurologic injury other than spinal cord injury
- •severe medical illness.
结局指标
主要结局
Change in medical status
时间窗: Baseline to post intervention, approximately 4 weeks
Safety of the intervention will be assessed as the number of participants who experience a reduction in medical stability and/or functionality from before to after the intervention.
Acceptability of the treatment
时间窗: Post intervention, approximately 4 weeks
Acceptability of the treatment will be assessed using the Treatment Evaluation Inventory-Short Form. Items are scored using a 5-point scale, with 1 equaling strongly disagree and 5 equaling strongly agree. TEI-SF scores can range from 9 to 45, with higher scores representing greater acceptance of the treatment.
Usability of the treatment
时间窗: Post intervention, approximately 4 weeks
Usability of the treatment will be assessed using the Usefulness, Satisfaction, and Ease of Use (USE) Questionnaire. Items are rated on a seven-point scale ranging from strongly disagree to strongly agree. A higher scale score indicates higher usability.
次要结局
- Change in clinical muscle strength(Baseline to post intervention, approximately 4 weeks)
- Change in current pain intensity(Baseline to post intervention, approximately 4 weeks)
- Change in upper limb function(Baseline to post intervention, approximately 4 weeks)
- Change in affect(Baseline to post intervention, approximately 4 weeks)