Condition category
Circulatory System
Date applied
17/11/2008
Date assigned
27/11/2008
Last edited
06/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helen Dawes

ORCID ID

Contact details

School of Life Sciences
Oxford Brookes University
Oxford
OX3 0BP
United Kingdom

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

http://www.brookes.ac.uk

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

Publication citations

Additional files

Editorial Notes

06/06/2016: No publications found, verifying study status with principal investigator.