Contact information
Type
Scientific
Primary contact
Prof Helen Dawes
ORCID ID
Contact details
Movement Science Group
School of Life Sciences
Gipsy Lane
Headington
Oxford
OX3 0BP
United Kingdom
hdawes@brookes.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13923
Study information
Scientific title
Acronym
Stroke WALK
Study hypothesis
People after stroke, despite being able to walk, have low levels of community mobility. The ability to cope with distractions is needed for successful community ambulation. To date, the effect of training walking whilst simultaneously performing cognitive distractor tasks [implicit dual task training (IDTT)] has not been explored.
Purpose: To examine the feasibility, effect and mechanism of IDTT within an aerobic walking program for people with chronic stroke.
Design: Pilot randomised trial with an active comparator control group
Setting: Community Exercise Centre
Participants: 50 people at least 6 months following a stroke
Intervention: IDTT group: 24 sessions of 45 minutes aerobic treadmill walking whilst performing implicit cognitive
distractor tasks. Tasks to include: listening, conversation, observational and thinking tasks.
Active comparator group: 24 sessions of 45 minutes aerobic walking training. Individuals instructed to focus on walking.
Measures: Community mobility, health and wellbeing, changes in walking performance including temporalspatial
parameters, walking endurance, adherence to training and the underpinning brain activation changes as measured during walking and simulated walking by Near InfraRed Spectroscopy (NIRS) and fMRI will be measured at 0,10 and 20 weeks.
Outcome: To determine the feasibility and effect of IDTT aerobic walking training to determine the need for and content of a Phase II/III trial. To investigate underlying mechanisms of different outcomes.
More detail can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13923
Ethics approval
NRES Committee South Central - Oxford C, 19 November 2012, Reference: 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
We will randomly assign participants into one of two treatment groups:
1. A 45 minute treadmill walking whilst performing distracting tasks group
2. A comparison 45 minute treadmill walking only group.
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
We will determine the effect of walking whilst performing distracting tasks training
Secondary outcome measures
No secondary outcome measures
Overall trial start date
30/01/2013
Overall trial end date
30/12/2014
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
Movement Science Group
Oxford
OX3 0BP
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 (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary