Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Satisfaction and Adherence Questionnaire
研究概览
简要总结
Vibration therapy is a possible alternative to drug-based treatments for spasticity following SCI. Research indicates that it may provide temporary relief from spasticity, but many interventions under investigation are not portable and therefore access is limited. The aim of this study is to investigate the feasibility of using a portable vibrating device to decrease UE spasticity.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have sustained cervical (neurological level C1-C8) SCI
- •Any ISNCSCI severity classification (A, B, C or D)
- •Have therapist-reported and self-reported spasticity in the arm or hand
- •Ability to pick up, move, and release at least one block (on the Box & Blocks Test)
- •May participate if utilizing prescription medications, including baclofen pump for control of spasticity
排除标准
- •Severe contractures of the arm/hand that limit passive movement of the elbow, wrist or fingers more than 50% of normal range of motion or presence of other orthopedic pathology that would adversely influence participation in the protocol
- •Any implanted catheter such as but not limited to CSF shunt, or the presence of pacemaker, implanted automatic internal cardioverter defibrillator (AICD, other cardiac implants and or conditions). Not including baclofen pump.
- •Severe pain or hypersensitivity of the arm/hand
- •Current pregnancy
研究组 & 干预措施
Vibrating Ball
Vibrating ball is held in both hands. Participants complete 5 30-second bouts of 68 Hz vibration with a 1 minute rest in between each bout.
干预措施: Vibrating ball (Other)
结局指标
主要结局
Satisfaction and Adherence Questionnaire
时间窗: 20 minute delay post intervention
Self- report of satisfaction with and perceived ability to adhere to the intervention
Change in Modified Ashworth Scale from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up
时间窗: Day 1
Clinical assessment of stretch-induced spasticity measured on a scale of 0-4 with 4 indicating the worst spasticity and 0 indicating no spasticity detectable upon clinical examination.
Change in Box and Blocks Test from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up
时间窗: Day 1
Functional assessment of grasp and release
Change in Global Impression of Change Scale from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up
时间窗: Day 1
Self-report of improvement or deterioration over time measured on a scale of 1-7 with 1 indicating very much improved and 7 indicating very much worse
次要结局
- Hand strength(Pre-intervention, immediately post-intervention, 20 minute delay post intervention)
- Qualities of Spasticity Questionnaire(Baseline)
- Pinch strength(Pre-intervention, immediately post-intervention, 20 minute delay post intervention)
- Semmes-Weinstein Monofilament Test(Pre-intervention, immediately post-intervention, 20 minute delay post intervention)