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Stroke in Young Adults Outdoor Rehabilitation

2022年8月25日 更新者:Dr Hannah Jarvis、Manchester Metropolitan University

Stroke in Young Adults: The Influence of An Outdoor Walking Rehabilitation Programme on Walking Performance and Quality of Life.

This research project aims to improve and promote physical activity participation in the outdoors and use outdoor walking as a form of long-term rehabilitation for young adults who have had a stroke.

This research is specifically focused on adults of working age (e.g. 18 to 65 years classed as young adults) as there is little to no research or rehabilitation programmes for young adults who have had a stroke on how best to regain function and independence to return to social/leisure activities, employment and education. During this study, The investigators will measure how fast a young adult who has had a stroke walks, how much energy they use to walk and how their joints move when walking. The investigators will also use questionnaires to measure how confident a young adult who has had a stroke is and how they feel when outdoors.

This project could highlight the positive role of exercising in outdoor natural environments to promote recovery following stroke in young adults. The investigators predict that an outdoor-walking rehabilitation programme could motivate the young stroke population to better engage in their rehabilitation, as walking in more challenging environments could facilitate an increase in the desire to walk outdoors and confidence.

研究概览

详细说明

This study is a randomised controlled trial, which will investigate whether an outdoor-walking rehabilitation programme can improve walking performance (how efficiently and how fast or slow an individual is able to walk) and quality of life of young adults who have had a stroke, compared to controls who have had a stroke, who will not be provided with the outdoor-walking programme. Forty-six individuals aged between 18 and 65 years, who have had a stroke in the last three years, will be recruited to participate in this study. Participants will be recruited from 3 health boards in Wales, United Kingdom: Aneurin Bevan University Health Board, Swansea Bay University Health Board and Cwm Taf University Health Board.

For the development of the outdoor-walking rehabilitation programme, the Consensus for Exercise Reporting Template (CERT) was followed. The outdoor-walking rehabilitation programme will run over 3 months and take place in Wales, United Kingdom. Each week will include once-per-week, outdoor-walking instructor-led sessions. The walking routes planned for the rehabilitation programme will be detailed in an exercise diary provided to the participant. This will include information such as distance, terrain (e.g gravel, tarmac, grass), environment (e.g woodland, lowland, moorland), gradient (e.g uphill to downhill ratio, how steep/ flat) and perceived level of difficulty.

The primary outcome measures for this study are walking speed and quality of life. Secondary outcomes include metabolic cost and biomechanical function. Outcomes will be measured pre and post 3-month rehabilitation data collection. Walking speed and metabolic cost will be measured during a 3-minute walking protocol. Quality of life will be measured using the standardised Stroke Aphasia Quality of Life (SAQOL), Confidence after stroke measure (CaSM) and Nature-relatedness scale (NR). Participants will also be asked to provide three difficulties they have experienced post-stroke (e.g difficulty walking) and three aims (e.g to go back to work) .

Biomechanical function will involve analysing joint kinetic and kinematics and measured during the biomechanical function protocol. Adherence to the outdoor-walking rehabilitation programme will be measured pre, post-rehabilitation and follow-up through the use of the exercise diary and questionnaires.

The results from this project will be used as benchmark data to provide evidence to support the role of outdoor rehabilitation in natural outdoor environments and green spaces for promoting health and wellbeing of young adults who have had a stroke.

研究类型

介入性

注册 (实际的)

12

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Rhondda Cynon Taff
      • Llantrisant、Rhondda Cynon Taff、英国、CF72 8XR
        • Cwm Taf Morgannwg University Health Board
    • South Wales
      • Newport、South Wales、英国、NP20 4SZ
        • Aneurin Bevan University Health Board
      • Swansea、South Wales、英国、SA2 8PP
        • Swansea Bay University Health Board

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Young adults who have had a stroke and capable of giving informed consent*
  • Aged 18-65 years
  • Male or Female
  • Stroke within the last 3 years
  • Cause of stroke from cerebral infarct or haemorrhage that is clinically evident or from a Computerised Tomography Scan (CT Scan) or Magnetic Resonance Imaging (MRI) Scan
  • Able to walk continuously for 5 minutes and have a walking speed between 0.6 and 0.9m/s. Walking speed will be ascertained by physiotherapists using the 10-metre walk test (10MWT).

    • If a participant has cognitive impairment we will rely on the expertise of the clinical team as to whether they have an adequate cognitive function to provide informed consent.

Exclusion Criteria:

  • A patient diagnosed with a respiratory disease, musculoskeletal disease or injury or an auto-immune disease will be excluded from this study if this comorbidity is the predominant health concern or the major factor that limits their ability to walk.
  • Amputation of more than one digit
  • Unable to speak or comprehend English*
  • Unable to or unwilling to comprehend informed consent
  • A patient is currently participating in another rehabilitation programme or study

    • Welsh translated versions of the participant information sheet, consent form and contact form will be provided to all participants. However, the participant must be able to understand spoken English as the data collection protocols will be explained in English by the researcher.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention: Outdoor walking Rehabilitation Programme
Participants in the intervention will be provided with an exercise diary. This will include walking routes for the instructor led 3-month outdoor-walking rehabilitation programme. The exercise diary will also include home exercises for the participants to complete twice-per-week that will be explained in detail, using coaching points and images to support. As these exercises will be completed at home. Each exercise has four progressions ranging from easy to hard.
Participants in the intervention group will take part in an instructor led outdoor walking rehabilitation programme which will last for 3 months. Alongside this participants will also be asked to complete a home exercise programme.
其他:Control: The light Stretches Programme
The control group intervention will be a non-exercise intervention to avoid training effects. The control group will be asked to keep to their normal activities of daily living and given ten targeted active stretches for the upper and lower body three times per week at home. Participants in the control group will each be provided a booklet for the given stretches.
Participants in the control group will be asked to keep to their normal activities of daily living, and given 10 targeted active stretches of the upper and lower body.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in walking speed
大体时间:5 months
Walking speed will be assessed by measuring the time to walk the middle 10m of a 15m walkway continuously for a total of 3-minutes. Scores are reported in meters/second with higher scores indicating better function. This will be recorded both indoors and outdoors and compared against the control.
5 months
Change in quality of life
大体时间:5 months
Change in quality of life will be assessed using the standardised Stroke Aphasia Quality of Life (SAQOL) that represents a measure of quality of life and compared to the control. Score is reported numbers with higher score indicating better quality of life.
5 months
Change in confidence (sub-measure of quality of life)
大体时间:5 months
Change in confidence will be assessed using the Confidence after stroke measure (CaSM), which is a comprehensive measure of confidence developed for use specifically after having a stroke and compared to the control. Score is reported numbers with higher score indicating better cpnfidence.
5 months
Change in nature-relatedness: attitudes to natural outdoor environments (sub-measure of quality of life)
大体时间:5 months
Change in attitudes to natural outdoor environments will be assessed using the Nature-relatedness scale (NR), which assesses subjective connectedness with the natural environment. Scores will be compared to the control. Score is reported numbers with higher score indicating better attitudes towards natural outdoor environments.
5 months
Change in aims and difficulties (sub-measure of quality of life)
大体时间:5 months
Change in quality of life will be further assessed by qualitative thematic analysis. This will involve asking participants to give three aims and three difficulties they have at the moment, which has been done in a previous study conducted by the research team to assess quality of life.
5 months

次要结果测量

结果测量
措施说明
大体时间
Change in metabolic cost (efficiency)
大体时间:5 months
Metabolic cost will be measured during the 3-minute walking test. Participants will walk at their self-selected walking speed. This will be recorded indoors and compared against the control group. Metabolic cost will be calculated by measuring oxygen consumption and then dividing the value by walking speed. Score is reported in millilitres/kg/metre with lower score indicating better efficiency.
5 months
Change in biomechanical function (gait analysis)
大体时间:5 months
Biomechanical function will involve analysing joint kinetic and kinematics during 7 walking trials on a 5m walkway. Changes in phases of the gait cycle (heel-strike, support, toe-off) will be compared pre and post rehabilitation, and control.
5 months
Adherence to the outdoor-walking rehabilitation programme
大体时间:5 months
Adherence to the outdoor-walking rehabilitation programme will be measured pre, post-rehabilitation and follow-up using the outdoor-walking rehabilitation programme exercise diary and the following questionnaires; Stroke aphasia quality of life scale, confidence after stroke measure, nature-relatedness and three aims and difficulties. An improvement to all scores in the questionnaires will indicate high adherence to the outdoor-walking rehabilitation programme.
5 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Hannah Jarvis、Research Associate

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年7月19日

初级完成 (实际的)

2021年10月8日

研究完成 (实际的)

2022年4月8日

研究注册日期

首次提交

2020年3月10日

首先提交符合 QC 标准的

2020年3月16日

首次发布 (实际的)

2020年3月19日

研究记录更新

最后更新发布 (实际的)

2022年8月29日

上次提交的符合 QC 标准的更新

2022年8月25日

最后验证

2022年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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