Contact information
Type
Scientific
Primary contact
Dr Matt Morrissey
ORCID ID
Contact details
Centre for Applied Biomedical Research (CABR)
Kings College London
Guys Campus
St Thomas Street
London
SE1 9RT
United Kingdom
+44 02078486678
matt.morrissey@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013180317
Study information
Scientific title
Acronym
Study hypothesis
Does the type of shoe worn in the early period early after ankle sprain influence recovery?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Injury, Occupational Diseases, Poisoning: Ankle sprain
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Self-assessment of ankle function via questionnaire
Secondary outcome measures
Not provided at time of registration
Overall trial start date
18/05/2006
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
40
Participant 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.
Recruitment start date
18/05/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Applied Biomedical Research (CABR)
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 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
Guy's and St. Thomas' NHS Foundation Trust (UK), Own account 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
No planned publication, due to lack of data.