Condition category
Injury, Occupational Diseases, Poisoning
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
23/04/2015
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

Mr John Hammond

ORCID ID

Contact details

Faculty of Health and Social Care Sciences
St George's Hospital Medical School
Cranmer Terrace
London
SW17 0RE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0236164465

Study information

Scientific title

Does lateral malleolus posterior glide taping affect ankle evertor muscle strength in recurrent ankle sprain?

Acronym

Study hypothesis

To evaluate evertor muscle strength in recurrent ankle sprain and the effect of a taping technique.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled cross-over trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Injury, Occupational Diseases, Poisoning: Ankle sprain

Intervention

Concentric and eccentric peak torque of evertor muscles will be measured at a constant velocity using an isokinetic dynamometer, the Cybex 6000 machine (Cybex, 2100 Smithtown Avenue, PO Box 9003, Ronkonkoma, NY 11779-0903). The Cybex software calculates and displays measures of muscle activity, eg. Peak torque, muscle work. This has been chosen as the cybex provides a more sensitive measures of muscle strength than that of more crude manual muscle testing (Munn et al 2003). Subjects will be positioned on the machine in supine with the hip and knee of the tested limb secured at 90 degrees flexion. The foot will be secured on the foot plate with the ankle in neutral. Prior to testing, the CYBEX machine will be calibrated to the individual's end rage of inversion and eversion.

The participants will be asked to complete a self-report functional questionnaire (adapted from de Bie et al 1997) which will determine the level of stability of the injured ankle. Both ankles of each subject will be tested, with the uninjured ankle acting as a control. Each ankle will be tested under three different conditions. To avoid experimental bias, the order of intervention and which ankle to test first will be randomised using random numbers (names drawn out of a hat).

1. Without tape
2. With tape and LMPG (active intervention)
3. With tape placed on skin without tension (placebo)

The LMPG will be applied as described by Mulligan (1999). The glide will be held in place with rigid adhesive tape (Hetherington 1996). To ensure consistency, the same researcher will apply the mobilisation each time. This will also be the case for application of tape.

Preparation for the study including a small pilot will be completed in September 2004. Data collection for the study will take place from October 2004 to February 2005 with final interpreting and analysis in March/April 2005.

Final Report May 2005

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Measurements of torgue (peak torgue), power and muscle work will be determined using the cybex.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

07/10/2004

Overall trial end date

01/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy adult male and female subjects
2. Age 18-65
3. Who attend St Georges Hospital who have had a history of recurrent ankle sprain, on at least two occasions, with the most recent episode occurring more than 4 weeks ago
4. Unilateral functional ankle instability, assessed by a self-report functional questionnaire (adapted from de Bie et al 1997)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Past history of orthopaedic surgery or fracture to the ankle
2. Any history of neurological conditions affecting balance or strength
3. Ankle pain at rest
4. Any known allergic reaction to tape

Recruitment start date

07/10/2004

Recruitment end date

01/07/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George's Hospital Medical School
London
SW17 0RE
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 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

St George's Healthcare NHS Trust (UK), 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

Publication citations

Additional files

Editorial Notes