Using the ReTrieve Automated Stereognosis System to Treat Loss of Tactile Function After Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number of Retrievals
研究概览
简要总结
Researchers aim to determine whether the ReTrieve system for tactile training can improve tactile function (sense of touch) in the hand after brain injury when used at home for 6 weeks.
详细描述
All participants who have been found eligible for this study and given informed consent will be randomized into two groups- either participants will begin ReTrieve training immediately following an initial assessment, or wait 8 weeks before beginning training.
During the study, participants will have a ReTrieve tactile training system delivered home for use over 6 weeks. Investigators will take three days to teach participants how to use the system. Each week for the remainder of the 6 weeks, participants will use this system for 4+ days per week on their own, and for 1 day supervised. During each supervised day, participants will complete approximately 1 hour of training while supervised over video chat with researchers.
Participants' tactile function will be assessed at three separate time points: once within one week before beginning training, once within one week after completing training, as well as once either 8 weeks before or 8 weeks after the training. This assessment has a required survey component, as well as an optional in-person clinical assessment component.
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
- None
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
- •English speaking
- •Be able to communicate and consent for themselves
- •Have experienced a brain injury more than 6 months prior to the date of study participation
- •Have chronic tactile deficits in at least one hand as a result of their brain injury
- •Have sufficient motor ability in their affected hand(s) to complete reach and grasp tasks
- •Have sufficient motor ability in their affected hand(s) to raise their arms above their head
- •Have sufficient motor ability in their affected hand(s) to hold objects
- •Have wireless internet and a laptop or mobile device at home for video conferencing
- •Live in the greater Dallas area
排除标准
- •Significant cognitive deficits that would preclude them from understanding instructions
- •Significant communication deficits that would preclude them from consenting for themselves
结局指标
主要结局
Number of Retrievals
时间窗: 6-8 weeks
The majority of participants should manage at least 4500 retrievals over their \~30 hours of system use
Number of Retrievals per Hour
时间窗: 6-8 weeks
The majority of participants should achieve at least 700 retrievals per hour by the end of training
次要结局
- Improved Tactile Function(6-8 weeks)
- Improved Perceived Tactile Function(6-8 weeks)