| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN79824117 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0013180317 |
| Public title | Effects of shoe type on ankle sprain recovery |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Injury, Occupational Diseases, Poisoning: Ankle sprain |
| Study hypothesis | Does the type of shoe worn in the early period early after ankle sprain influence recovery? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. 2 groups of 20 individuals contacted within 3 days of presenting to Guy's Minor Injury Unit with sprained ankle
2. Aged 18-60 years old |
| Participants - exclusion criteria | 1. Subjects with abnormal sensory problems in the thigh and lower leg, subjects with any neurological problem affecting their balance and subjects will be excluded.
2. Patients who have had musculoskeletal or neurological problem affecting their legs or low back which required medical attention in the last 6 months will also be excluded. |
| Patient information material |
|
| Anticipated start date | 18/05/2006 |
| Anticipated end date | 31/12/2007 |
| Status of trial | Completed |
| Target number of participants | 40 |
| Interventions | A randomised controlled trial involving participants being assigned control shoe (rocker) or experimental shoe (MDT). Measurements will be taken before and after to assess the difference. Subjects will be given instructions and diary for 1 week before returning for testing |
| Primary outcome measure(s) | Self-assessment of ankle function via questionnaire |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Guy's and St. Thomas' NHS Foundation Trust
Own account
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 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 fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Matt Morrissey |
| Contact details | Centre for Applied Biomedical Research (CABR)
Kings College London
Guys Campus
St Thomas Street
London
United Kingdom
SE1 9RT |
| Contact telephone | +44 02078486678 |
| Contact fax | +44 020 7848 6325 |
| Contact email | matt.morrissey@kcl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN79824117 |
| Date last extracted from ISRCTN register | 17/04/2008 |
