The Effect of SRS on Hemiplegia in Stroke Survivors: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Scores on ease of use, duration of wear, and preference related to wearing a stochastic resonance device at home in chronic stroke patients
研究概览
简要总结
Strokes are one of the leading causes of long term disability and death in the United States. A stroke occurs when the blood supply to the brain is blocked, damaging parts of the brain. Many stroke survivors have difficulty completing dexterous hand movements and manipulating objects due brain damage in the sensorimotor cortex. Damage to these areas can cause decreased motor movements and tactile sensation on the affected side. Research shows that tactile sensation is necessary for maintaining grip, grading grip forces and decreasing object slippage. Therefore, it is important to address tactile sensation with motor performance during stroke rehabilitation to improve performance outcomes among stroke survivors.
详细描述
A novel intervention that has shown immediate improvements in tactile sensation is called stochastic resonance stimulation. SRS is a phenomenon where cutaneous sensation can be enhanced with the presence of tactile noise in a nonlinear system. This theory suggests that the application of an imperceptible vibrotactile stimulation increases the synchronization of afferent neurons firing to the somatosensory cortex, ultimately increasing the excitability of mechanoreceptors in the skin suggesting that afferent signals from the periphery to the somatosensory cortex influence motor movements. However, more research is needed to document the changes in motor performance with the use of SRS and it is unclear how SRS stimulation changes different measurable sensory processing differences
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Stroke survivors over the age of 18
- •At least six months post stroke
- •Ability to provide verbal informed consent and written informed consent
- •Score of at least 56 on the Fugl meyer assessment total motor scores
- •Able to detect at least 6.65 (300 grams) on the Semmes Weinstein monofilament on both the pads of the thumb and index finger
- •Able to complete the nine hole peg test
- •Able to reliably express pain, discomfort, or fear
- •Speak english
排除标准
- •History of upper extremity orthopedic conditions, such as arthritis, surgery, etc.
- •Aphasia caused by stroke
- •Does not have AROM
- •Currently have muscle contractures in upper extremity
- •Participating in other research studies
- •Patients with electrically operated implanted device (e.g. cardiac pacemaker/defibrillator, drug delivery pump, and neurostimulator)
- •History of SMI (e.g. schizophrenia, schizoaffective disorder)
- •History of neurodegenerative disability (e.g. Multiple Sclerosis, Parkinson's Disease)
- •Have received botulinum injections in the paretic limb within the past three months
研究组 & 干预措施
Feasibility Arm
Wearing a stochastic resonance device at home in chronic stroke patients (six months or more post stroke).
干预措施: Sensory Threshold (Device)
Feasibility Arm
Wearing a stochastic resonance device at home in chronic stroke patients (six months or more post stroke).
干预措施: Nine Hole Peg Test (Behavioral)
Feasibility Arm
Wearing a stochastic resonance device at home in chronic stroke patients (six months or more post stroke).
干预措施: Semmes Weinstein Monofilament Assessment (Behavioral)
结局指标
主要结局
Scores on ease of use, duration of wear, and preference related to wearing a stochastic resonance device at home in chronic stroke patients
时间窗: Six months post stroke
To determine the feasibility of wearing a stochastic resonance device at home in chronic stroke patients. This is administered through a participant questionnaire. Some questions are point-based (scale of 1-5), and some are open-ended questions. A good score is considered to be a higher signal-to-noise ratio, indicating better performance and detection capabilities
Scores on ease of use, duration of wear, and preference related to wearing a stochastic resonance device at home in chronic stroke patients
时间窗: Six months post stroke
To determine the feasibility of wearing a stochastic resonance device at home in chronic stroke patients. This is administered through a participant questionnaire. Some questions are point-based (scale of 1-5), and some are open-ended questions. A good score is considered to be a higher signal-to-noise ratio, indicating better performance and detection capabilities
次要结局
- Optimal level of stochastic resonance vibration(Six months post stroke)