Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change in Wolf Motor Function Test (WMFT) Movement Time
研究概览
简要总结
The objective of this study is to determine if combining vibration with hand task practice is superior to hand task practice alone.
详细描述
Stroke is a leading cause of disability in the U.S., with more than 4 million stroke survivors in the U.S. who suffer from post-stroke hand disability. Post-stroke hand disability impairs stroke survivors' abilities and independence with self-care, hygiene, employment, and leisure, frequently resulting in diminished quality of life. Rehabilitation can often be limited, but research suggests that the effects of therapy is improved by the addition of sensory stimulation.
To fully leverage the potential therapeutic benefits of sensory stimulation, we have developed a new stimulation that is imperceptible random-frequency vibration applied to wrist skin. The objective of this study is to determine if this treatment is superior to task-practice alone in improving hand functional recovery, sensorimotor grip control, and neural communication.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •At least 6 months since stroke
- •Wolf Motor Function Test (WMFT) total average time >10 seconds
- •WFMT hand task average time <120 s
排除标准
- •Currently undergoing other upper limb therapy
- •Change in spasticity medication or upper limb botulinum toxin injection within 3 months prior to or during enrollment
- •Severe spasticity that limits participation in task practice therapy (e.g., Modified Ashworth Scale=4-5)
- •Comorbidity affecting the upper limb function such as complete upper extremity deafferentation, orthopaedic conditions limiting motion, premorbid neurologic conditions, premorbid peripheral neuropathy, compromised skin integrity of the wrist due to burn or long-term use of blood thinners, or significant new neurological symptoms
- •Language barrier or cognitive impairment that precludes following instructions and/or providing consent
研究组 & 干预措施
Vibration
The device will deliver imperceptible vibration for the treatment group.
干预措施: real stimulation (Device)
No Vibration
The device will deliver no vibration for the control group.
干预措施: No stimulation (Device)
结局指标
主要结局
Change in Wolf Motor Function Test (WMFT) Movement Time
时间窗: Baseline and 6 weeks
The Wolf Motor Function Test (WMFT) is a standardized, timed assessment of upper extremity motor function. This study reports the total average movement time across the WMFT tasks. Range: 0 seconds to \>120 seconds (no fixed upper limit). Interpretation: Lower movement times indicate better motor function. Only this WMFT movement-time variable was analyzed as the pre-specified primary outcome.
次要结局
- Change in Box and Blocks Test (BBT) Score(Baseline and 6 weeks)
- Change in Action Research Arm Test (ARAT) Score(Baseline and 6 weeks)