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21 March 2013
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| [ Print-friendly version ] |
| Improving community walking after a stroke, a new approach |
| ISRCTN | ISRCTN50586966 |
| DOI | 10.1186/ISRCTN50586966 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Improving community walking after a stroke, a new approach |
| Scientific title | |
| Acronym | Stroke WALK |
| Serial number at source | 13923 |
| 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 |
| Lay summary | Not provided at time of registration |
| 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Topic: Stroke Research Network; Subtopic: Rehabilitation; Stroke |
| Participants - 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. |
| Participants - 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. |
| Anticipated start date | 30/01/2013 |
| Anticipated end date | 30/12/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | UK Sample Size: 50 |
| Interventions |
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. |
| Primary outcome measure(s) | We will determine the effect of walking whilst performing distracting tasks training |
| Secondary outcome measure(s) | No secondary outcome measures |
| Sources of funding | The Stroke Association (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Helen Dawes |
| Address |
Movement Science Group
School of Life Sciences Gipsy Lane Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 0BP |
| Country | United Kingdom |
| hdawes@brookes.ac.uk | |
| Sponsor | Oxford Brookes University (UK) |
| Address |
Movement Science Group
School of Life Sciences Gipsy Lane Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 0BP |
| Country | United Kingdom |
| Sponsor website: | http://www.brookes.ac.uk/ |
| Date applied | 28/02/2013 |
| Last edited | 28/02/2013 |
| Date ISRCTN assigned | 28/02/2013 |
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