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ISRCTN
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ISRCTN59902842
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ClinicalTrials.gov identifier
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Public title
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Neural correlates of cognitive motor interference (CMI) while walking
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Scientific title
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Cortical activation of cognitive motor interference while walking: a near-infrared spectroscopic study
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Acronym
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CMI
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Serial number at source
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TSA 2007/09
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Study hypothesis
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1. There may be a relationship between the degree of regional brain activation and/or the temporal activation pattern and performance in cognitive and motor tasks under dual task conditions
2. This relationship may be different following a stroke than in healthy controls
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Lay summary
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Ethics approval
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Oxfordshire Research Ethics Committee C, approved on 24th July 2008 (ref: 08/H0606/55)
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Study design
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Observational cross-sectional study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Stroke
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Participants - inclusion criteria
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Patients will be selected from those treated in the Oxford Radcliffe Hospitals who are:
1. More than 6 months following a first stroke
2. Both males and females, aged 45 to 80 years
3. With an ischaemic infarct upon computed tomography (CT) or magnetic resonance imaging (MRI) scan
3. Able to perform a simple reciprocal bilateral foot tapping task, walk safely on a treadmill with or without mobility aids
4. Be able to give informed consent
Sex and age-matched controls will be chosen who do not have a known neurological disease, a history of hypertension, cardiac disease or diabetes.
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Participants - exclusion criteria
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1. Dementia
2. Aphasia significantly limiting communication
3. History of previous symptomatic strokes or neurological disease
4. Known psychiatric disease or claustrophobia, or other conditions precluding safe MRI (e.g., pacemaker or other metal implant)
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Anticipated start date
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01/07/2008
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Anticipated end date
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01/07/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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36
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Interventions
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Baseline assessments include:
1. The Mini Mental State Examination: the MMSE is a brief screening tool to provide quantitative assessment of cognitive function. It consists of 11 simple questions or tasks. Typically, they are grouped into seven domains; orientation to time, orientation to place, registration of three words, attention and calculation.
2. Edinburgh Handedness Inventory: this is a brief questionnaire of 10 short items, which determines subject's hand dominance.
3. Barthel Index: a simple index of independence in activities of daily living (ADL). It consists of 10 common ADL activities, which they are assessed for independence/dependence.
4. Modified Physical Activity Scale for the elderly: a self reported physical activity questionnaire that covers one week.
5. Berg Balance Scale (BBS): the BBS provides a quantitative assessment of balance. It consists of 14 items requiring subjects to maintain or complete movement tasks of varying levels of difficulty. All items are common to everyday life.
The results of the assessments above will be reported together with the primary/secondary outcomes, as they might correlate with differences in CMI.
Brain activation in both stroke and control subjects will be examined by near-infrared spectroscopy (NIRS) alongside behavioural performance of walking and cognitive tasks (calculation). The participants will be asked to perform the concurrent tasks when seated and walking. Gait parameters will be measured using a well-validated gait analysis system (Xsens, The Netherlands).
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Primary outcome measure(s)
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Task related changes in oxygenated and deoxygenated haemoglobins in the frontal lobe as measured by NIRS.
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Secondary outcome measure(s)
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1. Rate of backward calculation (number per minute)
2. Number of errors in backward calculation (errors per trial)
3. Spatiotemporal gait measures (speed, cadence, step time, stride time, step length, stride length, step width)
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Sources of funding
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The Stroke Association (UK) (ref: TSA 2007/09)
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Trial website
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Publications
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Contact name
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Dr
Helen
Dawes
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Address
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School of Life Sciences
Oxford Brookes University
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City/town
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Oxford
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Zip/Postcode
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OX3 0BP
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Country
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United Kingdom
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Sponsor
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Oxford Brookes University (UK)
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Address
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c/o Prof Linda King
School of Life Sciences
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City/town
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Oxford
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Zip/Postcode
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OX3 0BP
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Country
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United Kingdom
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Sponsor website:
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http://www.brookes.ac.uk
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Date applied
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17/11/2008
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Last edited
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27/11/2008
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Date ISRCTN assigned
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27/11/2008
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