Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fugl Meyer Assessment of Motor Recovery after Stroke change from baseline, 3 months, 4 months, 7months and 8 months
研究概览
简要总结
The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within stroke patients. vCR will be administered with a device called the Vibrotactile (VT) Brain Glove. vCR is expected to provide patients with a non-invasive therapy to aid in recovery from a stroke. This study will include a dedicated sham arm that will aid in understanding true treatment effects from vCR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at the time of enrollment: 18-80 years
- •Diagnosis of ischemic or hemorrhagic stroke
- •Disease period of more than 6 months
- •Mini Mental State Examination of at least 24 points
- •No medications that affect balance
- •Motor deficit
- •Use of Motricity Arm and Leg index to include impaired individuals with some functioning
- •Modified Rankin Scale for Neurologic Disability: Scores 3 or 4
排除标准
- •Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression
- •Any current drug or alcohol abuse
- •History of recurrent or unprovoked seizures
- •Any neurological disorder treatments that involve intracranial surgery or device implantation
- •Participation in another drug, device or biologic trial concurrently or within the preceding days
- •Pregnancy, breastfeeding or wanting to become pregnant during the trial
- •History or presence of other major neurological or orthopedic diseases other than stroke that limits motor functioning or cognitive ability
- •More than 5 degrees of contracture at shoulder, elbow, wrist, finger, hip, knee, or ankle
- •Botox, baclofen or any other treatment for spasticity except for bracing or splinting within the previous 3 months
- •Must be able to communicate with staff
- •Severe sensory abnormalities of the fingers such as vibratory urticaria
结局指标
主要结局
Fugl Meyer Assessment of Motor Recovery after Stroke change from baseline, 3 months, 4 months, 7months and 8 months
时间窗: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The scale is comprised of five domains and there are 155 items in total. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.
Neuro Quality of Life Upper Extremity Short Form test change from baseline, 3 months, 4 months, 7months and 8 months
时间窗: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
The Neuro quality of life upper extremity short form test measures the functionality of upper extremities. This is a self-report questionnaire that has a Likert scale from 1 to 5, with 5 indicating no difficulties and 1 indicating unable to do. Total possible points are out of 40, with a higher score indicating better upper extremity abilities.
次要结局
- Vibratory temporal discrimination task(This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit)
- Barthel Index for Activities of Daily Living change from baseline, 3 months, 4 months, 7months and 8 months(This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit)
- Timed Up and Go test change from baseline, 3 months, 4 months, 7months and 8 months(This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit)
- Neuro Quality of Life Lower Extremity Short Form test change from baseline, 3 months, 4 months, 7months and 8 months(This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit)
- Action Research Arm Test change from baseline, 3 months, 4 months, 7months and 8 months(This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit)
- Sensorimotor reaction time task(This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit)
研究者
Peter Tass, MD, PhD
Protocol Director
Stanford University