StrokeNCT04314388
Stroke in Young Adults Outdoor Rehabilitation
A study testing Intervention: Outdoor Walking Rehabilitation Programme in people with Stroke, run by Manchester Metropolitan University at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Intervention: Outdoor Walking Rehabilitation Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 19 Jul 2021to 8 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Cwm Taf Morgannwg university Health Board
Llantrisant, Rhondda Cynon Taff, CF72 8XR
Aneurin Bevan University Health Board
Newport, South Wales, NP20 4SZ
Swansea Bay University Health Board
Swansea, South Wales, SA2 8PP
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Intervention: Outdoor Walking Rehabilitation Programme, Control: The light Stretches Programme
- Keywords
- Stroke, Stroke Rehabilitation, Outdoor Walking, Walking Performance, Young Adults, Quality of life
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: Outdoor Walking Rehabilitation ProgrammeOther
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.
Control: The light Stretches ProgrammeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Outdoor walking Rehabilitation Programme | Experimental | 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. Receives: Other: Intervention: Outdoor Walking Rehabilitation Programme |
| Control: The light Stretches Programme | Other | 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. Receives: Other: Control: The light Stretches Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
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.
Measured: 5 months
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.
Measured: 5 months
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.
Measured: 5 months
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.
Measured: 5 months
Secondary outcomes (3)
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.
Measured: 5 months
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.
Measured: 5 months
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start19 Jul 2021
- Primary completion8 Oct 2021
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to two groups using blocked randomisation (stratified by site).
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Brecon Beacons National Park Authority
- Responsible party
- Principal investigator, Dr Hannah Jarvis, Manchester Metropolitan University
- Investigators
- Hannah Jarvis, Principal investigator, Research Associate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314388
- Sponsor's protocol ID
- 271699_OutdoorStrokeRehab
- Status last verified
- Aug 2022
- First submitted
- 10 Mar 2020
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke in Young Adults: The Influence of An Outdoor Walking Rehabilitation Programme on Walking Performance and Quality of Life.
- ClinicalTrials.gov ID
- NCT04314388
- Acronym / sponsor ID
- 271699_OutdoorStrokeRehab
- Conditions
- Stroke
- Keywords
- Stroke, Stroke Rehabilitation, Outdoor Walking, Walking Performance, Young Adults, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Manchester Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Brecon Beacons National Park Authority
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to two groups using blocked randomisation (stratified by site).
| Arm | Type | Receives |
|---|---|---|
| Intervention: Outdoor walking Rehabilitation Programme | Experimental | Other: Intervention: Outdoor Walking Rehabilitation ProgrammeParticipants 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. |
| Control: The light Stretches Programme | Other | Other: Control: The light Stretches ProgrammeThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention: Outdoor Walking Rehabilitation ProgrammeParticipants 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. | Other | Intervention: Outdoor walking Rehabilitation Programme |
| Control: The light Stretches ProgrammeParticipants 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. | Other | Control: The light Stretches Programme |
Primary outcome
Change in walking speed
Time frame: 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.
Change in quality of life
Time frame: 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.
Change in confidence (sub-measure of quality of life)
Time frame: 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.
Change in nature-relatedness: attitudes to natural outdoor environments (sub-measure of quality of life)
Time frame: 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.
Change in aims and difficulties (sub-measure of quality of life)
Time frame: 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.
3 secondary outcomes
Change in metabolic cost (efficiency)
Time frame: 5 months
Change in biomechanical function (gait analysis)
Time frame: 5 months
Adherence to the outdoor-walking rehabilitation programme
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Jarvis principal investigator
Research Associate
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention: Outdoor Walking Rehabilitation Programme in people with Stroke, run by Manchester Metropolitan University at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in walking speed (time frame: 5 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.