Feasibility of a Video Telehealth Model to Evaluate Home Use of Transcutaneous Spinal Cord Stimulation for Enhanced Upper Limb Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- NASA-TLX (NASA Task Load Index)
研究概览
简要总结
The proposed study will focus on the feasibility of and effectiveness to a home-based program for persons with chronic SCI focused on upper limb training augmented with a transcutaneous neurostimulator supported via a video telehealth platform.
详细描述
The overarching goal of this study is to train participants with tetraplegia and their companion to operate a non-invasive surface applied neurostimulation unit (ONWARD, ARCex) while performing a prescriptive functional task based upper extremity home program for 2 months. Participants will be supported with video-telehealth to assist with any difficulties that may arise and to progress their upper extremity home program. Evaluations will assess the feasibility of this video telehealth supported model as measured by the ease of use of the technology (QUEST 2.0, NASA-TLX) as well as participants ability to attend and complete all the training visits. Changes in upper extremity physical function will be measured using validated clinical tools (GRASSP, CUE-Q, DASH, COPM) as well as detailed evaluation of upper extremity muscle activation from surface EMG and strength measurements of pinch and grasp.
The primary outcome measure of this study is feasibility, and the secondary outcome measure is to capture changes in upper extremity performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All gender, any ethnicity
- •Cervical Spinal Cord Injury C2-8
- •American Spinal Injury Association (ASIA) Impairment Scale (AIS) B, C or D
- •GRASSP-Prehension Score >10 or GRASSP Strength Score >30
- •Greater than 1 year post injury
- •Able to identify a companion to assist with neurostimulator setup in home environment.
- •Internet connection to support video telehealth connection
- •Willingness to travel to the VA Palo Alto Medical Center
排除标准
- •Cardiopulmonary disease or cardiac symptoms,
- •Autonomic dysreflexia that is uncontrolled or severe,
- •Implanted medical device(s),
- •Uncontrolled spasms that could limit participation in exercise training,
- •Skin breakdown or active pressure injury in areas of electrode placement.
- •Participants must not be engaged in any concurrent drug or device trial
- •Pregnant, are planning to become pregnant, or breastfeeding
- •The study is not deemed safe or appropriate in the opinion of the investigators
结局指标
主要结局
NASA-TLX (NASA Task Load Index)
时间窗: At 8 weeks (after completion of home program)
Measures subjective mental work load \& physical effort
QUEST 2.0 (Quebec User Evaluation of Satisfaction with assistive Technology)
时间窗: At 8 weeks (after completion of home program)
Measures usability of device (eg, adjustability, comfort, safety and effectiveness)
次要结局
- CUE-Q (Capabilities of Upper Extremity Function)(At entry (Baseline) and repeated at 8 weeks (after completion of home program))
- DASH (Disabilities of the Arm, Shoulder, and Hand)(At entry (Baseline) and repeated at 8 weeks (after completion of home program))
- GRASSP (The Graded Redefined Assessment of Strength Sensibility and Prehension)(At entry (Baseline) and repeated at 8 weeks (after completion of home program))
- COPM (Canadian Occupational Performance Measure)(At entry (Baseline) and repeated at 8 weeks (after completion of home program))
研究者
Beatrice Jenny Kiratli PhD
Research Health Scientist
VA Palo Alto Health Care System