| Source of record | UK Trials |
| ISRCTN | ISRCTN74845476 |
| Date ISRCTN assigned | 29/09/2006 |
| Local reference number(s) | N0453162803 |
| Public title | The effects of patellar tape on neural correlates during knee joint proprioception tests using fMRI: a pilot study |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Musculoskeletal Diseases: Knee |
| 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. |
| Design/methodology | Pilot RCT |
| Research ethics review | No ethics information provided as of 29 September 2006 |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Eight 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. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated start date | 26/04/2005 |
| Anticipated end date | 31/01/2007 |
| Status of trial | Completed |
| Target number of participants | 8 healthy volunteers |
| Interventions | 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). |
| Primary outcome measure(s) | The primary outcome measure will be neural processing in the brain as a result of application of patellar tape detected by the BOLD technique using fMRI. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Central Manchester and Manchester Children's University Hospitals NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr MICHAEL CALLAGHAN |
| Contact details | MRI Central Manchester & Manchester Children's University Hospitals
Manchester Royal Infirmary
Oxford Road
Manchester
United Kingdom
M13 9WL |
| Contact telephone | +44 0161 906 7509 |
| Contact fax | +44 |
| Contact email | Michael.Callaghan-2@manchester.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN74845476 |
| Date last extracted from ISRCTN register | 17/04/2008 |
