Dosing Effects of an Upper Extremity Rehabilitation Program Using a Brain-Computer Interface Mediated Robotic Hand Orthosis for Chronic Stroke Patients: IpsiHand System
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity
研究概览
简要总结
This study aims to assess whether the NeuroLutions Upper Extremity Rehabilitation System (known as IpsiHand) will help stroke patients regain strength and functional movements in their arm. The IpsiHand system involves using a hand robotic device that is controlled by brain waves, known as a Brain-Computer Interface (BCI). By using the device, participants will be harnessing brainwaves from the side of their brain not affected by stroke to control the robotic device on the hand that is weaker from the stroke.
详细描述
This trial aims to assess the effectiveness of the NeuroLutions Upper Extremity Rehabilitation System, known as IpsiHand, on functional motor recovery and neuroplasticity for chronic stroke survivors with hemiparesis (N=27). The IpsiHand system involves a Brain-Computer Interface (BCI) as a control for a robotic hand orthosis. Participants will complete 16-32 weeks of home therapy with the IpsiHand system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
An occupational therapist independent to the study will review and score 2 outcome measures (Fugl-Meyer and Action Research Arm Test). The study coordinator will randomize the order of the videos for each participant, so that the outcome assessor will not know which time point they are scoring. In other words, the video-outcome assessor will be blinded to the order of the assessments as they are scoring them but will not be blinded to the intervention as all participants will be receiving the same intervention.
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
- •Diagnosis of stroke(s), with most recent stroke at least 6 months prior to study start (can be ischemic or hemorrhagic)
- •PROM: Full extension of digits 2 and 3 at MPs, PIPs, and DIPs
- •English speaking
- •Intact cognition to provide informed consent
- •Intact language skills to comprehend and follow directions
- •Experiencing difficulty performing ADLs with affected upper limb
- •Upper extremity Botox allowable, but not required
- •Botox users must continue regimen at regular intervals for duration of study
- •Botox users will provide clinic note for each injection (date, dose, and muscle location)
- •Botox + Study Schedule
- •At study initiation, Botox injection will occur between 3-7 days prior to baseline measurement and initiation of device use
- •Repeat Botox injections must be completed at least 3 days prior to any administration of the outcome measures
排除标准
- •Concurrent participation in another study
- •Co-morbid orthopedic condition/pain limiting functional use of the impaired upper limb
- •History of neurological disorder other than stroke
- •Botox user unable to comply with above noted requirements
- •Ongoing physical or occupational therapy addressing the upper limb
- •Ongoing electric stimulation or other rehabilitative devices (e.g. robotics, virtual reality) to upper limb
- •Cognitive impairment: Short Blessed Test Score 9
- •Significant spasticity: Modified Ashworth Scale score 3 at the elbow
- •Significant hemispatial neglect: Mesulam Cancellation Test 3 unilaterally
- •Insufficient Strength: Motricity Index score for shoulder abduction 18
- •Significantly impaired sensation of impaired upper limb: National Institutes of Health Stroke Scale - Item 8 (Sensory) score of 2
- •History of cranioplasty
- •History of seizure disorder
- •No changes to usual exercises, splint use, or oral baclofen/anti-spasticity medication use during trial
结局指标
主要结局
Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity
时间窗: Baseline through 3 months post no device use
The Fugl-Meyer is a scale that measures capacity of the arm. There are 33 items that evaluate reflexes, active movement, grasp patterns, speed, and coordination of the arm and hand. Each item is scored from 0-2, with a maximum total score of 66. Higher scores indicate better performance.
次要结局
- Action Research Arm Test(Baseline through 3 months post no device use)
- Box and Block Test(Baseline through 3 months post no device use)
研究者
Joel Stein, MD
Professor and Chair of the Department of Rehabilitation and Regenerative Medicine
Columbia University