Condition category
Not Applicable
Date applied
10/12/2017
Date assigned
12/12/2017
Last edited
30/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
An ankle sprain is an injury to the tough bands of tissue (ligaments) that surround and connect the bones of the leg to the foot. During physical activity, the ankle may twist inward as a result of sudden or unexpected movement. Fatigue and joint position sense are two elements that affect ankle sprain. Joint position sense measures the individual’s ability to perceive the position of a joint. Fatigue impairs joint position sense, which makes the incidence of ankle sprain high. Ankle tape is widely used to prevent ankle sprain, but is still not approved if ankle tape improve joint position sense after fatigue. The aim of this study is to examine if ankle tape can affect the joint position of the ankle after muscle fatigue.

Who can participate?
Healthy adults aged 16 to 40 years old.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group do not receive any ankle tape. Those in the second group receive ankle tape. Participants are measured before and after muscle fatigue to assess the impact of the ankle tape.

What are the possible benefits and risks of participating?
There are no direct benefits or risks associated with participating.

Where is the study run from?
University Hospital Marburg (Germany)

When is the study starting and how long is it expected to run for?
December 2011 to December 2013

Who is funding the study?
University Clinic Marburg (Germany)

Who is the main contact?
1. Mr Akram Jahjah (Scientific)
2. Dr El-Zayat Bilal Farouk (Scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Mr Akram Jahjah

ORCID ID

Contact details

Kelsterbacherstr.9
Frankfurt
60528
Germany

Type

Scientific

Additional contact

Dr El-Zayat Bilal Farouk

ORCID ID

Contact details

Center of Orthopedics and Traumatology
University Hospital Marburg
Baldingerstrasse
Marburg
35033
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DRKS00013590

Study information

Scientific title

The effect of ankle tape on joint position sense after local muscle fatigue: a randomized controlled trial

Acronym

Study hypothesis

Does the tape affect the joint position sense on the ankle after muscle fatigue in healthy subjects?

Ethics approval

Ethical committee of Philipps-University Marburg (Germany), 17/04/2012, ref: study 23\12

Study design

Interventional single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information

Condition

Healthy subjects

Intervention

Participants are randomly distributed into control (without ankle tape) and intervention (with ankle tape) groups In both groups, joint position sense was measured before and after local muscle fatigue. For participants in intervention group tape is applied just before the first test and it was removed after second test. Preventive taping for injuries to the lateral aspect of the ankle joint is used and applied according to Macdonald’s method. Fatigue protocol was applied by Biodex System Isokinetic Dynamometer 3. The local load applied to the ankle joint consisted of 30 consecutive maximal concentric/concentric contractions of the ankle evertors and invertors in the range of motion ROM (30° of eversion and 30° of inversion) at an angular velocity of 120°/s. Immediately after the fatigue protocol, joint position sense testing is initiated using the same methods as in the testing before fatigue, to minimize the effects related to recovery from fatigue.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

1. Active joint position sense (Joint position sense in Absolute Error (AE) and variable Error (VE)) is measured using the Biodex 3 at baseline
2. Passive joint position sense is measured using the Biodex 3 at baseline
3. Active joint position sense is measured using Biodex 3 after fatigue
4. Passive joint position sense is measured using Biodex 3 after fatigue

Secondary outcome measures

1. Fatigue Index (Fatigue Index = (initial peak torque - final peak torque) / initial peak torque * 100) is measured using Biodex 3 after first test
2. Work is measured using Biodex 3 after first test
3. Work at first third measured using Biodex 3 after first test
4. Work at last third measured using Biodex 3 after first test

Overall trial start date

01/12/2011

Overall trial end date

01/12/2013

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Healthy volunteers between 16 and 40 years of age

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

34

Participant exclusion criteria

1. History of lower extremity injuries
2. Neurologic deficits
3. Rheumatologic disease
4. Hypermobility

Recruitment start date

01/05/2012

Recruitment end date

30/08/2012

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital Marburg
Apartment for Physiotherapy Baldingerstrasse
Marburg
35033
Germany

Sponsor information

Organisation

Universitätsklinikum Gießen und Marburg, Standort Marburg

Sponsor details

Baldingerstraße
Marburg
35033
Germany

Sponsor type

University/education

Website

www.ukgm.de

Funders

Funder type

Hospital/treatment centre

Funder name

University Clinic Marburg

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in BMC Musculoskeletal Disorders. Study protocol is available in German.

IPD Sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Akram Jahjah at akramjahjah@yahoo.com.

Intention to publish date

31/01/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29316902

Publication citations

Additional files

Editorial Notes

30/01/2018: Publication reference added.