Plain English Summary
Background and study aims
A stroke is a serious condition where the blood supply to a part of the brain is cut off, usually by a blood clot blocking an artery (ischaemic stroke) or a bleed (haemorrhagic stroke). Many stroke victims suffer from long-term complications depending on the area of the brain that is affected, which can affect their ability to move, speak or even their cognitive function (memory loss, difficulty reasoning and confusion). One of the most common complications of a stroke is weakness or paralysis on one side of the body. The leg is often affected by this, making movements such as walking very difficult. Patients therefore often need extensive physiotherapy to help them recover. Community walking after stroke is often affected even if stroke survivors have had good recovery of leg function. This study aims to explore the feasibility and possible effect of dual task treadmill training (walking on the treadmill while completing thinking tasks) to improve community walking ability in stroke survivors.
Who can participate?
Adults who have had a stroke at least six months ago who have difficulty walking.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are asked to walk for 45 minutes on a treadmill whilst performing distracting tasks (dual task). This involves completing mental processing tasks such as counting backwards or chatting with the trainer. Those in the second group are asked to walk for 45 minutes on a treadmill whilst concentrating on their walking. Both groups take part in 24 sessions spread over a course of 10 weeks. At the start of the study and then after 11 and 22 weeks, participants complete a range of assessments to evaluate their walking performance, community walking, health and wellbeing and dual task walking ability.
What are the possible benefits and risks of participating?
Treadmill walking exercise has been shown to be an effective intervention for improving mobility, health, wellbeing and fitness in people following stroke. Participants in both groups will benefit from participation in treadmill walking. There are no risks in taking part. Exercise training is carried out by trained professionals and heart and blood pressure are monitored before and after training.
Where is the study run from?
1. Clinical Exercise and Rehabilitation Unit, Oxford Brookes University (UK)
2. St Crispin's Leisure Centre (UK)
When is the study starting and how long is it expected to run for?
August 2011 to August 2016
Who is funding the study?
The Stroke Association (UK)
Who is the main contact?
Professor Helen Dawes
hdawes@brookes.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Helen Dawes
ORCID ID
http://orcid.org/0000-0002-2933-5213
Contact details
Movement Science Group
School of Life Sciences
Gipsy Lane
Headington
Oxford
OX3 0BP
United Kingdom
+44 1865 483469
hdawes@brookes.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13923
Study information
Scientific title
A single blinded randomized controlled trial to explore the efficacy of a 10 week dual task treadmill training in comparison to treadmill training without distraction on walking performance and community walking in chronic stroke survivors
Acronym
Stroke WALK
Study hypothesis
Dual task treadmill training will improve community walking levels, dual task ability and confidence about community walking more than training treadmill walking without dual tasks.
Ethics approval
NRES Committee South Central - Oxford C, 19/11/2012, ref: 12/SC/0403
Study design
Pilot randomised trial with an active comparator control group
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Stroke Research Network; Subtopic: Rehabilitation; Stroke
Intervention
Participants will be into one of two treatment groups using a computer generated randomization list 1:1 into one of both groups with stratification for baseline treadmill speed to balance groups for walking performance.
Intervention group: Participants perform 45 minute treadmill walking whilst performing distracting tasks. This involves performing arious cognitive tasks whilst walking (i.e. counting backwards in steps of 3 or 7, listening to audio fragments, chatting with the trainer about planning daily activities).
Comparison group: Participants perform 45 minute treadmill walking, and are trained to focus on the walking as much as they can without be distracted.
The training sessions will be run over ten weeks, with individuals completing 24 sessions in this period. The sessions will be supported in a Clinical Exercise and Rehabilitation Unit. Individuals will initially walk for as long as they are comfortably able. Both training groups receive a 10 week biweekly training. Each training session lasts for a maximum of 45 min, or when a person is not able to complete the full 45 minutes, as long as they can handle. During the training 30 minutes will be in the aerobic training zone (55%-85% maximum heart rate).
Training is preceded by a baseline assessment to assess walking performance, community walking, health and wellbeing and dual task walking ability. Another assessment is done after 10 weeks of training and a follow-up assessment is performed at 22 weeks (10 week follow-up).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Primary outcomes as of 16/01/2017:
1. Walking performance is measured using the Two minute walk test at baseline, 11, 22 weeks
2. Walking performance in dual task conditions is measured using the Two minute walk test with distraction at 0, 11, 22 weeks
3. Community walking ability and confidence about community walking is measured using Community walking questions at at 0, 11, 22 weeks
Original primary outcome:
Effect of walking whilst performing distracting tasks training
Secondary outcome measures
Added 16/01/2017:
1. Dual task effect on walking distance during two minute walk with distraction is measured by the change in walking distance from single to dual task at baseline, 11, 22 weeks
2. Number of cognitive responses during two minute walk with distraction is measured by cognitive response rate walking at baseline, 11, 22 weeks
3. Physical activity level is measured using the Physical activity scale for elderly at baseline, 11, 22 weeks
4. Physical activity and community walking levels are measured using Step activity monitors, worn for a week at baseline, 11, 22 weeks
5. General health and wellbeing are measured using the SF-36 questionnaire at baseline, 11, 22 weeks
6. Health and wellbeing on the day is measured using the EQ-5D questionnaire at baseline, 11, 22 weeks
7. Community walking levels specified for specific surroundings is measured using the Modified version of the University of Alabama study of Aging Life Space Assessment at baseline, 11, 22 weeks
Overall trial start date
01/08/2011
Overall trial end date
31/08/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults will be selected who are more than 6 months following a first stroke with some walking impairment. Walking impairment will be determined by asking participants, on initial expression of interest to participate, if they have a walking problem (Yes/No) and confirmed by a reduced six minute walk distance (compared to normative data) on testing
2. With an ischaemic infarct
3. Able to perform a simple reciprocal bilateral foot tapping task
4. Walk safely on a treadmill with or without mobility aids and to give informed consent.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 50
Total final enrolment
50
Participant exclusion criteria
1. Individuals with a high risk of psychosis
2. Aphasia significantly limiting communication
3. History of previous symptomatic stroke or neurological disease
4. A mental state that precludes safe participation (as stated by GP or referring consultant)
5. Any known contraindication to safe participation in exercise.
6. Individuals will be checked for safe participation in the MRI scanning: claustrophobia, or other conditions precluding safe MRI (e.g., pacemaker or other metal implant). Individuals determined safe and willing to take part will participate in additional scanning.
Recruitment start date
30/01/2013
Recruitment end date
30/12/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Exercise and Rehabilitation Unit
Sports Centre
Oxford Brookes University
Headington Campus
Oxford
OX3 0BP
United Kingdom
Trial participating centre
St Crispin's Leisure Centre
London Road
Wokingham
RG40 1SR
United Kingdom
Sponsor information
Organisation
Oxford Brookes University (UK)
Sponsor details
Movement Science Group
School of Life Sciences
Gipsy Lane
Headington
Oxford
OX3 0BP
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Stroke Association
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of the main results and a paper with a very detailed description of training and the clinical lessons learned in peer reviewed journals.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository of Oxford Brookes University.
Intention to publish date
31/08/2017
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30308699 (added 21/08/2019)