The effects of patellar tape on neural correlates during knee joint proprioception tests using fMRI: a pilot study
| ISRCTN | ISRCTN74845476 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74845476 |
| Secondary identifying numbers | N0453162803 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 09/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Callaghan
Scientific
Scientific
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
| Phone | +44 0161 306 0542 |
|---|---|
| michael.callaghan@manchester.ac.uk |
Study information
| Study design | Pilot RCT |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | The effects of patellar tape on neural correlates during knee joint proprioception tests using fMRI: a pilot study |
| Study objectives | 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(s) | Added June 2008: approved by Salford and Trafford LREC, ref 05/Q1404/17. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 26/04/2005 |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 8 healthy volunteers |
| Total final enrolment | 8 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 26/04/2005 |
| Date of final enrolment | 31/01/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Specialist & Research Associate
Manchester
M13 9PT
United Kingdom
M13 9PT
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)
No information available
NHS R&D Support Funding
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/01/2012 | 09/08/2021 | Yes | No |
Editorial Notes
09/08/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
