Effects of shoe type on ankle sprain recovery

ISRCTN	ISRCTN79824117
DOI	https://doi.org/10.1186/ISRCTN79824117
Protocol serial number	N0013180317
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder	Guy's and St. Thomas' NHS Foundation Trust (UK), Own account NHS R&D Support Funding

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

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does 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) studied	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
Primary outcome measure(s)	Self-assessment of ankle function via questionnaire
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Not Specified
Target sample size at registration	40
Key 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
Key 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.
Date of first enrolment	18/05/2006
Date of final enrolment	31/12/2007

Centre for Applied Biomedical Research (CABR)

London
SE1 9RT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan