Contact information
Type
Scientific
Primary contact
Dr Michael Callaghan
ORCID ID
Contact details
Clinical Specialist & Research Associate
Centre for Rehabilitation Science
ARC Epidemiology Unit
School of Translational Medicine
University of Manchester
Oxford Road
Manchester
M13 9PT
United Kingdom
+44 0161 306 0542
michael.callaghan@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0453162803
Study information
Scientific title
Acronym
Study hypothesis
The principle objective is to discover if there is any increase in brain activity when subjects perform a simple proprioceptive test with and without a piece of tape across the knee cap.
Ethics approval
Added June 2008: approved by Salford and Trafford LREC, ref 05/Q1404/17.
Study design
Pilot RCT
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Musculoskeletal Diseases: Knee
Intervention
The subjects will lie in the scanner wearing shorts. A plastic block will support the thigh and knee at an angle of 45 degrees of knee inflexion. A strap will be placed over the hips to further limit head motion as a consequence of lower limb motion. Every effort will be made to control head movement by using a foam pad velcro strap and a bite bar. To ensure minimum ankle, foot and toe movements during the test, these joints will be placed in a neutral position and held by a temporary plaster cast and velcro straps.
MR scanning using the BOLD technique will be performed using a 1.5 tesla machine. The scanning protocol will be based on a functional time series. Each time series will consist of 4 blocks of 4 conditions: knee joint extension to 0deg, extension to 20deg with or without patellar tape. Each condition will last 5 minutes consisting of 30 sec on (ie the task) and 30 sec off (no task) and will be triggered by an auditory command given by using headphones customised for fMRI experiments. A metronome will pace the movements using sound in order to impose a constant timing and equal no of cycles across conditions.
Patellar taping will then be applied. The order of tape/no tape will be randomised
The acquired images will be assessed carefully for head movement and in order to correct the confounding effects induced by head movement realignment parameters. To process the data, statistical parametric mapping will be used to display the significance of activation and to analyse functional and anatomical image. SPM is the most prevalent approach to characterising activity related changes (Friston et al 2000).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Neural processing in the brain as a result of application of patellar tape detected by the BOLD technique using fMRI.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
26/04/2005
Overall trial end date
31/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
8 healthy volunteers between the ages of 20-40 years will have refrained from any physical exercise for 3 days prior to the testing. They will sign a consent form after reading the study information sheet and after having had the opportunity to ask questions about any aspect of the study and their role.
There is no control group. All subjects will act as their own internal controls.
Participant type
Healthy volunteer
Age group
Adult
Gender
Not Specified
Target number of participants
8 healthy volunteers
Participant exclusion criteria
Added June 2008:
1. Histories of neurological or cardiovascular disease
2. Cochlear implants or any metal objects in the body
3. Cardiac or neural pacemakers
4. Histories of serious musculoskeletal injury in both lower limbs
Recruitment start date
26/04/2005
Recruitment end date
31/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Specialist & Research Associate
Manchester
M13 9PT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
Presented at the Annual Congress of the Chartered Society of Physiotherapy October 2008