A Pilot Study on Tolerance and Ease of Implementation of Intensive Visual Stimulation (IVS3) in Daily Practice for Upper Limb Motor Recovery in Outpatient Rehab Center
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of serious adverse events
研究概览
简要总结
This study measures participant satisfaction and upper extremity function in outpatients with chronic stroke when exposed to the IVS3 device. Investigators hypothesize that treatment with the IVS3 device will be feasible and tolerable for use in the outpatient setting.
详细描述
This study will investigate the implementation of the intensive visual stimulation three (IVS3) device in the outpatient rehabilitation setting. This is a phase I/II open label study that will assess participant satisfaction and upper extremity function in outpatients with chronic stroke (10 with hemi spatial neglect and 15 without), when exposed to IVS3 for 30 minutes and conventional treatment for 15 minutes, across 12 sessions in 4-6 weeks at Weill Cornell medicine outpatient rehabilitation (single site).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age ≥ 18 years old
- •English speaking
- •History of ischemic or hemorrhagic stroke ≥ 6 months prior to study enrolment
- •FMA-UE: 20 < x < 50 (moderate impairments)
- •With or without hemi spatial neglect
排除标准
- •Spasticity or increased tone with MAS ≥3 in the upper extremity
- •Unable to communicate effectively or provide informed consent
- •Significant visual impairments
- •Concurrent occupational therapy being received outside of the study
- •Pregnant or incarcerated individuals
研究组 & 干预措施
Hemi-spatial Neglect
Individuals with stroke with hemi-spatial neglect as identified on the star cancellation and line bisection tests.
干预措施: Intensive Visual Stimulation Device (Device)
No hemi-spatial neglect
Individuals with stroke without hemi-spatial neglect as identified on the star cancellation and line bisection tests.
干预措施: Intensive Visual Stimulation Device (Device)
结局指标
主要结局
Number of serious adverse events
时间窗: 12 treatment sessions over 4-6 weeks.
The primary outcome for safety is defined as the number of serious adverse events that occur while using the IVS3 device.
Mean number of sessions attended
时间窗: 12 treatment sessions over 4-6 weeks.
The primary outcome measure is defined as the mean number of sessions attended of the planned twelve visits. Min 0, Max 12.
次要结局
- Mean Client Satisfaction Questionnaire-8(Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15))
- Mean System Usability Scale (SUS)(Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15))