Ipsihand Device Use in Stroke Patients to Assess Motor Recovery of the Upper Extremity and Functional Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Fugl-Meyer Assessment - Upper Extremity
研究概览
简要总结
This study aims to evaluate the impact of the Neurolutions Upper Extremity Rehabilitation System, known as IpsiHand, on improving functional motor control for post-stroke patients with hemiparesis. The Neurolutions System is a brain-computer interface (BCI) comprised of a robotic orthosis, worn on the hand and wrist, and operated by the patient's brain waves which are measured by EEG electrodes. The system also utilizes a tablet interface to provide therapy instructions to the patient.
详细描述
Participants will complete 12 weeks of home therapy with the Neurolutions IpsiHand System. Outcomes will be based on a comparison of the patient's baseline measurements to post-therapy assessments.
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
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6-months or more post stroke
- •Presentation of upper extremity hemiparesis or hemiplegia
- •Participants must english speaking
- •Demonstrate intact cognition to provide informed consent
- •Botox injections are allowed, and must continue regimen at regular intervals throughout the study
排除标准
- •Not active in another clinical study
- •Not receiving formal therapy for the upper extremity
- •No use of other modalities or technologies to the upper extremity
- •Cognitive Impairment: Short Blessed Test Score 9 or above
- •Significant Spasticity: Modified Ashworth Scale score 3 or more at the elbow
- •Significant Hemispatial Neglect: Mesulam Cancellation Test 3 or more unilaterally
- •Insufficient Strength: Motricity Index score for shoulder abduction 18 - Any contractors of the affected upper extremity that would not allow the IpsiHand robotic exoskeleton to be worn comfortably and/or safely for device use
研究组 & 干预措施
IpsiHand Device
All participants will receive treatment with the IpsiHand Device.
干预措施: IpsiHand Therapy (Device)
结局指标
主要结局
Fugl-Meyer Assessment - Upper Extremity
时间窗: "Fugl-Meyer Assessment - Upper Extremity" average change in points from the baseline average score and 12-week average score.
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning 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 FMA is a score on a scale of 0 to 66 points. A lower score indicates impaired motor function in the upper extremity assessed. A higher score on the scale indicates better motor function of the upper extremity. A score of 66 would indicate there is no motor function impairment of the upper extremity.
次要结局
- Arm Motor Ability Test Change Points on Scale From Baseline to 12 Weeks(Change in AMAT score (points) from Baseline to 12 Weeks)