A Pilot Evaluation of the Effectiveness and Economic Impact of a Multi-Technology Rehabilitation Programme for Sub-acute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
研究概览
简要总结
The Biomedical Engineering Dept, University of Strathclyde, co-creates rehabilitation technology. In 2023-2024 a clinical study (NCT06787768) was conducted to understand the feasibility of a multi-technology approach to rehabilitation early after stroke. This was successful and leads to the next phase which is to gather preliminary evidence of the effectiveness of this approach by monitoring change in the mobility of patients who receive this intervention compared with usual care which will be gathered through a data linkage project (tracking the outcomes from matched patients from other parts of Scotland who receive usual care).
详细描述
Rationale A well-established multi-disciplinary research group at the University of Strathclyde (UoS) Biomedical Engineering department have developed and tested a multi-technology rehabilitation model as a solution to the gap between clinical need and current provision. The technology enriched rehabilitation model has been tested under controlled conditions with chronic stroke survivors (at least one-year post stroke) and shown to be feasible with preliminary evidence of efficacy. The model has since been tested on acute/sub-acute stroke patients in an NHS stroke unit and found to be feasible and clinically acceptable with early evidence of an increased rehabilitation dose. This early stroke population has greater potential for recovery as the brain is more receptive to recovery through structural changes to neural pathways (neuroplasticity), therefore delivering higher intensity rehabilitation is therefore more critical at this phase of rehabilitation.
Funding has now been secured to progress this work by gathering evidence on the effectiveness of this approach in recovery mobility (walking, balance and) as well as gathering preliminary evidence of cost effectiveness (healthcare use).
Overall aim To determine whether early, technology-based rehabilitation after stroke improves mobility compared with usual care, using a virtual control group from national linked data, and to identify factors that influence recovery and assess economic benefit.
Specific questions;
- In sub-acute stroke, does technology-enhanced rehabilitation improve mobility (mRMI) versus a virtual usual-care control identified via a data linkage study, 3 and 6 months after stroke?
- What is the relationship between delivered dose (hours of rehabilitation) and outcome?
- Which baseline factors influence outcomes?
- What are the potential economic benefits of the technology-based rehabilitation programme compared with usual care, based on differences in healthcare and social care resource use and patient outcomes, using national linked data?
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
盲法说明
No masking is used
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 new stroke by NHS Lanarkshire physician
- •More than 48 hours since stroke event
- •Deemed medically fit for rehabilitation by medical staff
- •Deemed to require rehabilitation
- •Able to provide informed consent
排除标准
- •Acutely medically unwell
- •Active cardiac disease, such as unstable angina
- •Active delirium/significant levels of confusion
- •Seizure within past 7 days
- •Individual currently being managed under the Adults with Incapacity Act, unless the responsible medic has noted within the document that the individual has capacity to consent to rehabilitation research
- •Known pregnancy