Plain English Summary

Not provided at time of registration

Trial website

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

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

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

Publication citations

Editorial Notes