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临床试验/NCT03709875
NCT03709875Unknown不适用

A Cost-effective Analysis of Telerehabilitation in Patients With Severe Acquired Brain Injury

IRCCS Centro Neurolesi "Bonino-Pulejo"2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年11月26日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
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

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.

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rocco Salvatore Calabrò

Professor

IRCCS Centro Neurolesi "Bonino-Pulejo"

研究点 (2)

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