Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TSA 2007/09
Study information
Scientific title
Cortical activation of cognitive motor interference while walking: a near-infrared spectroscopic study
Acronym
CMI
Study hypothesis
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
Ethics approval
Oxfordshire Research Ethics Committee C, 24/07/2008, ref: 08/H0606/55
Study design
Observational cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stroke
Intervention
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).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Task-related changes in oxygenated and deoxygenated haemoglobins in the frontal lobe as measured by NIRS.
Secondary outcome measures
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)
Overall trial start date
01/07/2008
Overall trial end date
01/07/2010
Reason abandoned
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
36
Participant exclusion criteria
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)
Recruitment start date
01/07/2008
Recruitment end date
01/07/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford Brookes University
Oxford
OX3 0BP
United Kingdom
Sponsor information
Organisation
Oxford Brookes University (UK)
Sponsor details
c/o Prof Linda King
School of Life Sciences
Oxford
OX3 0BP
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Stroke Association (ref: TSA 2007/09)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
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