Condition category
Injury, Occupational Diseases, Poisoning
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
22/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

No planned publication, due to lack of data.

Publication citations

Additional files

Editorial Notes