Telerehabilitation With Digital Technologies for the Continuum of Care of Stroke Patients: a Multicentre Randomized Controlled Trial on Effectiveness, Acceptability, Usability, and Economic Sustainability
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 13
- 主要终点
- Change from baseline in the Berg Balance Scale (BBS)
研究概览
简要总结
The goal of the pragmatic study is to evaluate the effectiveness of a home-based telerehabilitation protocol for patients with post-stroke disabilities, compared to a home-based educational program.
The main question it aims to answer is:
Is home-based neuromotor and cognitive rehabilitation using digital tools more effective than a traditional educational program for improving static and dynamic balance in patients with subacute and chronic stroke? Researchers will compare the outcome (Berg Balance Scale) measured at baseline with the outcome after treatment to test its effectiveness.
详细描述
The aim of the study is to evaluate the effectiveness of a home-based treatment based on rehabilitation technologies by comparing it with a traditional educational program at home.
Primary objective: Demonstration of the superiority of a home-based rehabilitation program with digital tools (home-based technological telerehabilitation) over a home-based educational program (home-based usual care) in patients with stroke outcomes in improving static and dynamic balance.
Secondary objectives:
- Evaluation of the impact of the frequency of the intervention on recovery;
- Evaluation of the acceptability of the intervention with digital tools for the patient, the caregiver, and the health care provider;
- Evaluation of the usability of the intervention with digital tools for the patient and the caregiver;
- Evaluation of the economic sustainability of the integrated rehabilitation intervention with digital tools for the patient, the payer, and society through the creation of a cost-effectiveness, cost-utility, and, for the health system, budget impact analysis model evaluation and prediction, and related sensitivity analyses.
The study is designed as a multicenter, multimodal, randomized, controlled, parallel group (1:1), blinded interventional trial. It will be conducted at multiple clinical centers participating in a national research initiative. Randomization will be centralized and stratified by clinical center, time since stroke, and age.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of first ischemic or hemorrhagic stroke verified by Computed Axial Tomography or MRI.
- •Age greater than 18 years.
- •Latency since the event: a) greater than 3 months and less than or equal to 6 months; b) greater than 6 months and less than 24 months.
- •Ability to perform the Timed Up and Go Test.
排除标准
- •Unstable clinical conditions.
- •Behavioral/cognitive disorders that prevent adequate patient compliance with the study (severe cognitive impairment, Montreal Cognitive Assessment<17.5).
- •Severe visual impairment that cannot be corrected by lenses, preventing the patient from performing treatment with digital instruments.
- •Refusal to sign informed consent.
研究组 & 干预措施
Treatment with Digital Tools
The experimental treatment involves home-based telerehabilitation protocols utilizing digital tools. Patients will perform task-oriented activities aimed at improving balance through standing and/or seated exercises under both static and dynamic conditions. Exercise complexity will be progressively adapted and personalized based on the patient's performance, improvement trajectory, and instrumental feedback from the digital system.
All devices must have a CE mark for medical devices and be used according to the manufacturer's specifications.
干预措施: Integrated Treatment with Digital Tools (Other)
Educational Program
Patients in the Control Group will follow a self-guided educational program supported by printed materials outlining daily living activities to be performed at home.
干预措施: Home-Based Educational Program (Other)
结局指标
主要结局
Change from baseline in the Berg Balance Scale (BBS)
时间窗: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
次要结局
- Trunk control test(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- Fugl-Meyer Assessment for the upper extremities - motor function(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- Fugl-Meyer Assessment for the upper extremities - sensory function(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- Fugl-Meyer Assessment for the lower extremities - sensory function(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- Modified Ashworth Scale(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- 5-level EQ-5D version (EQ-5D-5L)(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- Fugl-Meyer Assessment for the lower extremities - motor function(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- Modified Rivermead Motricity Index(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- Symbol Digit Modalities Test(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- Motricity Index for upper extremities(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- Functional Ambulation Classification Scale(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- Frontal Assessment Battery(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- World Health Organization disability assessment schedule 2.0 - WHODAS 2.0(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- Modified Barthel Index(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- Motricity Index for lower extremities(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- Numerical Rating Scale for Pain(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)
- Neuropathic Pain 4 Questions(Baseline; within 7 days after the end of the 6-week observation/rehabilitation period)