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临床试验/NCT06928285
NCT06928285尚未招募不适用

Community Rollout of Technology Enriched Rehabilitation After Stroke: An Implementation Study

University of Strathclyde0 个研究点目标入组 120 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
10-meter walk test (10mWT)

研究概览

简要总结

The minimum guideline recommendations for rehabilitation after stroke are not being met. This compromises individual recovery and increasing the global burden of disability. A multi-technology solution, co-created with people living with stroke, has been shown to be feasible in both sub-acute and chronic populations but has not been implemented as an integrated rehabilitation service.

The aim of this implementation study is to assess the ability of a technology enriched model of rehabilitation to deliver guideline recommendations in a range of NHS and local authority settings that provide rehabilitation services to stroke survivors at different stages of their recovery. The findings will be used to co-create a scalable, adaptable, and sustainable model that meets rehabilitation guidelines.

详细描述

A recently completed pilot study (NCT05981729) demonstrated the feasibility of our multi-technology circuit based model of rehabilitation in an acute NHS stroke unit (UHW, NHS Lanarkshire). The key findings were that the model delivered an average of 52 minutes of additional rehabilitation every day, without any safety concerns and with supervision provided by rehabilitation assistants. Importantly for future implementation the participating patients and ward staff were all very positive about the novel approach. The challenge now is to translate these positive findings into a sustainable national solution that maintains fidelity to the key parameters of evidence-based rehabilitation (personalised, high intensity, and enriched environment) and can be adopted by diverse service providers (NHS, Local Authority, and medical charities) across various settings, to support people through their whole recovery journey.

Aim To develop an acceptable and sustainable implementation model of technology enriched rehabilitation after stroke that sustainably delivers NICE (National Institute for Clinical Effectiveness) guideline recommendations in a range of rehabilitation settings and phases of recovery after stroke.

Design This is an implementation study using a mixed methods approach to assess technology enriched rehabilitation gyms across a network of NHS, local authority and 3rd sector funded rehabilitation services. Part of the implementation study will involve gathering preliminary evidence of efficacy through comparison with a control group matched for age and stroke through a data linkage project (eDRIS, Data Scotland).

Locations Four locations have agreed to participate, they represent different stages of recovery after stroke, from acute illness (University Hospital Wishaw, Wishaw, UK) to community care (Blantyre Life, Blantyre, UK) and Edinburgh Community Stroke Service, Edinburgh, UK) and long-term maintenance (Olympia leisure centre, Dundee, UK). At one location (Edinburgh) the study will also test whether a higher dose of rehabilitation can be delivered within current resources including participant tolerance and what resources are required to maintain a high dose delivery.

Participants All participants will have a diagnosis of stroke (physician diagnosed) and be suitable for rehabilitation. Specific eligibility criteria, such as time since stroke, will vary across the locations and are detailed later.

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

入选标准

  • Diagnosis of stroke
  • Currently well
  • Suitable for rehabilitation (motor/ciommunication and or/cognitive impairment(
  • Able to attend the programme for two hours at least twice a week
  • Able to follow instructions in English and follow provide verbal and/or written feedback

排除标准

  • Absolute contradictions to physical activity
  • Recent (6 weeks) deterioration in health
  • Change in medication
  • Currently unwell

结局指标

主要结局

10-meter walk test (10mWT)

时间窗: Three time points; 1) Two weeks before intervention starts at the initial induction meeting,2) immediately before the intervention, and 4) immediately after intervention ends

Time to walk 10 metres

Five times sit to stand movement

时间窗: Three time points; 1) Two weeks before intervention starts, at the induction meeting,2) immediately before the intervention and 3) immediately after intervention ends

Time to complete five sit to stand movements safely.

次要结局

  • Stroke Impact Scale(Two time points; 1) Two weeks before intervention starts and 2) immediately after intervention ends)
  • Action Research Arm Test (ARAT)(Two time points; 1) Two weeks before intervention starts and 2) immediately after intervention ends)

研究者

申办方类型
Other
责任方
Sponsor

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