Stroke in Young Adults Outdoor Rehabilitation

NCT04314388 | Completed

• 1 other identifier: 271699_OutdoorStrokeRehab
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke

Keywords

Stroke; Stroke Rehabilitation; Outdoor Walking; Walking Performance; Young Adults; Quality of life

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  5 months

Secondary Outcomes (3)

• Change in metabolic cost (efficiency)

  5 months

• Change in biomechanical function (gait analysis)

  5 months

• Adherence to the outdoor-walking rehabilitation programme

  5 months

Study Arms (2)

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.

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.

Other: Control: The light Stretches Programme

Interventions

Intervention: Outdoor Walking Rehabilitation Programme OTHER

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: Outdoor walking Rehabilitation Programme

Control: The light Stretches Programme OTHER

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.

Control: The light Stretches Programme

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester Metropolitan University: lead
• Brecon Beacons National Park Authority: collaborator

Study Sites (3)

Cwm Taf Morgannwg university Health Board

Llantrisant, Rhondda Cynon Taff, CF72 8XR, United Kingdom

Location

Aneurin Bevan University Health Board

Newport, South Wales, NP20 4SZ, United Kingdom

Location

Swansea Bay University Health Board

Swansea, South Wales, SA2 8PP, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hannah Jarvis

  Research Associate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants or the research team will not be blinded to the allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Participants will be randomly allocated to two groups using blocked randomisation (stratified by site).

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 19, 2020
• Study Start: July 19, 2021
• Primary Completion: October 8, 2021
• Study Completion: April 8, 2022
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)