Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Short-latency Afferent Inhibition
研究概览
简要总结
More than 4 million stroke survivors in the U.S. suffer from post-stroke sensorimotor hand disability, which is typically permanent and difficult to treat. Hand disability has a profound negative impact on functional ability and independence. One way to improve hand function is to use peripheral sensory stimulation. Sensory stimulation in conjunction with therapy has been shown to improve motor outcomes more than therapy alone. While promising, most modalities of sensory stimulation interfere with natural hand tasks. To address these practical limitations, we have developed a new stimulation, imperceptible random-frequency vibration applied to wrist skin via a watch. In this study, we will determine if use of this vibration increases hand functional recovery.
详细描述
The study design is a double-blinded randomized controlled study. Subjects will wear the device for at least 8 hours/day every day for a month, during which they will come to the laboratory for weekly evaluation. Follow-up evaluation will occur 3 months after. The device will deliver vibration (treatment) or no vibration (control).
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
- •Chronic stroke survivor (>= 6 months post stroke)
- •Ability to move an object with the paretic hand
- •Fingertip sensory deficits
- •Ability to put on a watch daily (by oneself or with help)
排除标准
- •Currently undergoing other upper extremity rehabilitation therapy
- •Upper limb botulinum toxin within 3 months prior to or during enrollment
- •Change in neurological disorder medications during the enrollment
- •Complete upper limb deafferentation
- •Rigidity (Modified Ashworth Scale=5)
- •Brainstem stroke
- •Comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners)
- •Language barrier or cognitive impairment that precludes following instructions and/or providing consent
- •If a participant has contraindications for Transcranial Magnetic Stimulation (TMS), the participant will not do TMS.
结局指标
主要结局
Short-latency Afferent Inhibition
时间窗: 1 month
motor evoked potential suppression by conditioning electrical stimulation
次要结局
- Action Research Arm Test(1 month)