Condition category
Circulatory System
Date applied
28/02/2013
Date assigned
28/02/2013
Last edited
16/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

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

http://www.brookes.ac.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/01/2017: The following changes have been made to the record: 1. The scientific title, secondary outcome measures, publication and dissemination plan, IPD sharing plan, ORCID ID, plain English summary and trial participating centres have been added 2. The overall trial dates have been updated from 30/01/2013 - 30/12/2014 to 01/08/2011- 31/08/2016 3. Information about the randomisation process and length of training sessions have been added to the interventions section 05/01/2017: No publications found in PubMed, verifying study status with principal investigator.