Vibrotactile Stimulation for Neurological Disorders
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
研究概览
简要总结
The goal of this clinical trial is to investigate upper-extremity vibrotactile stimulation with wearables in stroke patients. The main questions it aims to answer are:
Are the wearables well-tolerated by patients? Does the vibrotactile stimulation help regain arm function?
Participants will wear vibrotactile stimulation gloves and shirts for 5 hours daily during their stay at the rehabilitation unit, in addition to conventional therapy. Researchers will compare the treatment group (vibrotactile stimulation wearables) with a control group (conventional therapy only) to see the effects of the vibrotactile stimulation.
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
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients at rehabilitation units
- •Unilateral left or right sided ischemic stroke within the previous 2 weeks
- •Have Upper-Extremity Fugl-Meyer scores between 6 and 58
- •Have at least 20 degrees of active shoulder elevation and elbow flexion
- •Expected to stay 1-3 weeks in the rehabilitation unit
排除标准
- •Under anti-spasticity therapy
- •Patients that are dependent on pacemakers
- •Patients that have defibrillators
- •Have lymphedema or AV fistula for dialysis on an arm
研究组 & 干预措施
Vibrotactile Stimulation
Participants wear vibrotactile stimulation shirts and gloves for 5 hours per day, 7 days per week, during their stay at the rehabilitation unit, which is expected to be between 2-3 weeks. Participants wear the devices after conventional therapy is done for the day.
干预措施: Vibrotactile Stimulation (Device)
Control
Participants undergo conventional therapy only.
结局指标
主要结局
Change in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
时间窗: Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions. Scores are between 0 and 66.
次要结局
- Number of participants who completed the therapy(End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).)
- Number of participants who tolerated the vibrotactile stimulation therapy(End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).)
- Change in the modified Ashworth scale(Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).)
- Number of participants with at least one adverse event(End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).)