ISRCTN ISRCTN79824117
DOI https://doi.org/10.1186/ISRCTN79824117
Secondary identifying numbers N0013180317
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
22/08/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Matt Morrissey
Scientific

Centre for Applied Biomedical Research (CABR)
Kings College London
Guys Campus
St Thomas Street
London
SE1 9RT
United Kingdom

Phone +44 02078486678
Email matt.morrissey@kcl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesDoes the type of shoe worn in the early period early after ankle sprain influence recovery?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedInjury, Occupational Diseases, Poisoning: Ankle sprain
InterventionA 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.
Intervention typeOther
Primary outcome measureSelf-assessment of ankle function via questionnaire
Secondary outcome measuresNot provided at time of registration
Overall study start date18/05/2006
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexNot Specified
Target number of participants40
Key inclusion criteria1. 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
Key exclusion criteria1. 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.
Date of first enrolment18/05/2006
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Centre for Applied Biomedical Research (CABR)
London
SE1 9RT
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Guy's and St. Thomas' NHS Foundation Trust (UK), Own account NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan