Bedside Telerehabilitation Early After CNS Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- TRCare, Inc.
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Safety of daily beside telerehabilitation based on incidence of treatment-emergent adverse events as assessed by regular review of the medical record and patient interview
研究概览
简要总结
The goal of this clinical trial is to assess the safety and feasibility of providing extra doses of rehabilitation therapy for persons with a recent stroke, traumatic brain injury (TBI) and/or spinal cord injury (SCI). The therapy treatment targets to improve arm function by introducing telerehabilitation to the bedside of participants during the inpatient rehab admission period. Participants will use a newly developed functional training system (HandyMotion) to access therapy treatment program directly from their hospital room. HandyMotion is a sensor-based training system that can connect to the TV set in the hospital room, enabling patients to access their therapy training program to practice rehab-oriented games and exercises ad libitum, at any time of the day.
详细描述
This clinical trial is designed to address 3 specific aims:
Aim 1: To measure the safety of daily bedside telerehabilitation.
Aim 2: To measure the feasibility of daily bedside telerehabilitation.
Aim 3: To derive a preliminary estimate of motor and functional outcomes in patients engaged in daily bedside telerehabilitation. This is an uncontrolled pilot study, and so it is understood that such measures cannot be attributed to the telerehabilitation intervention, however, these measures will describe the clinical course of a patient engaged in this intervention.
Telerehabilitation therapy is delivered over the course of the inpatient rehabilitation stay. A therapist-facing web portal is used for treatment planning and patient monitoring. The treatment approach was initially designed based on an upper-extremity task-specific training manual and Accelerated Skill Acquisition Program.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •CNS injury with onset in the prior 90 days
- •For stroke: Stroke that is radiologically verified and due to ischemia or to intracerebral hemorrhage.
- •For traumatic brain injury: History that is consistent with TBI; and score on the Revised Rancho Levels of Cognitive Functioning Scale is at least 6 out of
- •For spinal cord injury: Traumatic or nontraumatic, incomplete cervical SCI.
- •At least one arm must have motor deficits that are neither very mild nor devastating (dense arm plegia). Operationally, this requires that the Visit 1 Box & Block Test score is at least 1 block, but no more than 30 blocks, in 60 seconds.
- •Possess enough arm movement to participate in therapy, including able to hold the HandyMotion device in the paretic hand(s), using an assistive device if needed.
- •Informed consent signed by the subject (no surrogate consent permitted for this study)
- •Able to follow simple instructions
- •Study participation is not likely to be significantly limited by agitated behavior
排除标准
- •A major, active, coexistent neurological or psychiatric disease that would limit study participation, e.g., advanced dementia or active psychosis
- •Expectation that patient's cognitive status will likely interfere substantially with playing assigned games or exercises
- •Deficits in communication that interfere with reasonable study participation
- •Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye
- •Subject does not speak sufficient English to comply with study procedures
- •Shoulder pain that in the judgement of the study team is likely to substantially limit the amount of TR therapy completed
结局指标
主要结局
Safety of daily beside telerehabilitation based on incidence of treatment-emergent adverse events as assessed by regular review of the medical record and patient interview
时间窗: "For approximately 4 weeks, up until discharge"
Safety will be measured in terms of adverse events (AEs) deemed related to use of the telerehabilitation system on a probable or definite basis.
次要结局
- Feasibility of daily bedside telerehabilitation based on measurement of patient compliance, as determined by reviewing electronic records of device usage("baseline" and "immediately after end of treatment")
- Box and Blocks Test("baseline" and "immediately after end of treatment")