A Cost-effective Analysis of Telerehabilitation in Patients With Severe Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- WHO Disability Assessment schedule
研究概览
简要总结
We will investigate the use of TR, based on advanced Information and Communication Technology (ICT) solutions, taking into account that the supervision of rehabilitation at home will be enriched with the counselling and vital parameters monitoring. The aim of the study is to evaluate that TR is at least non-inferior in comparison with the same amount of usual territorial rehabilitative physical treatments (UTRT), taking into account patients' functional recovery, psychological well-being, caregiver burden, and healthcare costs. The enrolled patients will be balanced for pathology and randomized in two groups, performing TR (G1) or standard rehabilitation training (G2), respectively, according to a pc-generated random assignment.TR will be delivered by means of an advanced video-conferencing system, whereas the patient will be provided with low-cost monitoring devices, able to collect data about his/her health status and QoL. In both the groups each treatment (either cognitive or motor, or both as per patient functional status) will last about one hour a day, five days/week, for 12 weeks. Two structured telephone interviews will be administered to the patients (when possible) and/or their caregivers, and to all the healthcare professionals involved in the patient management, one week after the beginning and at the end of the TR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age range 18 to 65 years; diagnosis of SABI; availability at home internet connection.
排除标准
- •severe cognitive and behavioral impairments, cardio-respiratory instability or other medical illness potentially interfering with the treatment, severe limb spasticity, high-risk of spontaneous fracture, substance abuse.
研究组 & 干预措施
TR Treatment
TR will be delivered by means of an advanced video-conferencing system, and patients will be provided with low-cost monitoring devices, able to collect data about the health status and QoL. All treatments from remote are based on scheduled videoconferences between the patient's home and the Clinical Units, and therapists can control and modify the exercises. A virtual reality based system, consisting of two PC-based workstations, located at the patient's home and at the rehabilitation center, will be used. For the motor treatments the patient has to move the real end effector, following the trajectory of the corresponding virtual task displayed on his computer screen. The speech and cognitive exercises will be delivered from the two Research Institutes to the patient's home.
干预措施: TR Treatment (Device)
Conventional Treatment
In this group patients will be treated with conventional physiotherapy and speech training, adjusted in reason of the clinical needs, as usually. Treatments for motor limbs activity will be focused on functional active-assistive and active exercises. Conventional "paper and pencil" training will be used to improve cognitive function.
干预措施: TR Treatment (Device)
结局指标
主要结局
WHO Disability Assessment schedule
时间窗: 3 months
This generic assessment instrument for health and disability may be considered a tool to produce standardized disability levels and profiles. It is applicable across cultures, in all adult populations, and is directly linked at the level of the concepts to the International Classification of Functioning, Disability and Health (ICF).
Montreal Cognitive assessment
时间窗: 3 months
he Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment.he MoCA test is a one-page 30-point test administered in approximately 10 minutes.
次要结局
- Fugl- Meyer for Upper limb(3 months)
研究者
Rocco Salvatore Calabrò
Professor
IRCCS Centro Neurolesi Bonino Pulejo