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Stroke in Young Adults Outdoor Rehabilitation

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intervention: Outdoor Walking Rehabilitation Programme
Control: The light Stretches Programme
Sponsored by
Manchester Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Stroke, Stroke Rehabilitation, Outdoor Walking, Walking Performance, Young Adults, Quality of life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cwm Taf Morgannwg university Health Board
  • Aneurin Bevan University Health Board
  • Swansea Bay University Health Board

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention: Outdoor walking Rehabilitation Programme

Control: The light Stretches Programme

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in walking speed
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.
Change in quality of life
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.
Change in confidence (sub-measure of quality of life)
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.
Change in nature-relatedness: attitudes to natural outdoor environments (sub-measure of quality of life)
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.
Change in aims and difficulties (sub-measure of quality of life)
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.

Secondary Outcome Measures

Change in metabolic cost (efficiency)
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.
Change in biomechanical function (gait analysis)
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.
Adherence to the outdoor-walking rehabilitation programme
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.

Full Information

First Posted
March 10, 2020
Last Updated
August 25, 2022
Sponsor
Manchester Metropolitan University
Collaborators
Brecon Beacons National Park Authority
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1. Study Identification

Unique Protocol Identification Number
NCT04314388
Brief Title
Stroke in Young Adults Outdoor Rehabilitation
Official Title
Stroke in Young Adults: The Influence of An Outdoor Walking Rehabilitation Programme on Walking Performance and Quality of Life.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
October 8, 2021 (Actual)
Study Completion Date
April 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Manchester Metropolitan University
Collaborators
Brecon Beacons National Park Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Stroke Rehabilitation, Outdoor Walking, Walking Performance, Young Adults, Quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly allocated to two groups using blocked randomisation (stratified by site).
Masking
None (Open Label)
Masking Description
Participants or the research team will not be blinded to the allocation.
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Outdoor walking Rehabilitation Programme
Arm Type
Experimental
Arm Description
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.
Arm Title
Control: The light Stretches Programme
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intervention: Outdoor Walking Rehabilitation Programme
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control: The light Stretches Programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in walking speed
Description
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.
Time Frame
5 months
Title
Change in quality of life
Description
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.
Time Frame
5 months
Title
Change in confidence (sub-measure of quality of life)
Description
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.
Time Frame
5 months
Title
Change in nature-relatedness: attitudes to natural outdoor environments (sub-measure of quality of life)
Description
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.
Time Frame
5 months
Title
Change in aims and difficulties (sub-measure of quality of life)
Description
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.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Change in metabolic cost (efficiency)
Description
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.
Time Frame
5 months
Title
Change in biomechanical function (gait analysis)
Description
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.
Time Frame
5 months
Title
Adherence to the outdoor-walking rehabilitation programme
Description
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.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah Jarvis
Organizational Affiliation
Research Associate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cwm Taf Morgannwg university Health Board
City
Llantrisant
State/Province
Rhondda Cynon Taff
ZIP/Postal Code
CF72 8XR
Country
United Kingdom
Facility Name
Aneurin Bevan University Health Board
City
Newport
State/Province
South Wales
ZIP/Postal Code
NP20 4SZ
Country
United Kingdom
Facility Name
Swansea Bay University Health Board
City
Swansea
State/Province
South Wales
ZIP/Postal Code
SA2 8PP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Stroke in Young Adults Outdoor Rehabilitation

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