Neural correlates of cognitive motor interference (CMI) while walking
| ISRCTN | ISRCTN59902842 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59902842 |
| Secondary identifying numbers | TSA 2007/09 |
- Submission date
- 17/11/2008
- Registration date
- 27/11/2008
- Last edited
- 06/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helen Dawes
Scientific
Scientific
School of Life Sciences
Oxford Brookes University
Oxford
OX3 0BP
United Kingdom
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Cortical activation of cognitive motor interference while walking: a near-infrared spectroscopic study |
| Study acronym | CMI |
| Study objectives | 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(s) | Oxfordshire Research Ethics Committee C, 24/07/2008, ref: 08/H0606/55 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/07/2008 |
| Completion date | 01/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 36 |
| Key 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. |
| Key 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) |
| Date of first enrolment | 01/07/2008 |
| Date of final enrolment | 01/07/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oxford Brookes University
Oxford
OX3 0BP
United Kingdom
OX3 0BP
United Kingdom
Sponsor information
Oxford Brookes University (UK)
University/education
University/education
c/o Prof Linda King
School of Life Sciences
Oxford
OX3 0BP
England
United Kingdom
| Website | http://www.brookes.ac.uk |
|---|---|
"ROR" |
https://ror.org/04v2twj65 |
Funders
Funder type
Charity
Stroke Association (ref: TSA 2007/09)
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
06/06/2016: No publications found, verifying study status with principal investigator.
