Neuromuscular Control of the Ankle With External Support

September 23, 2014 updated by: Dr. med. Benita Kuni, MD, University Hospital Heidelberg
Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim of our study is to quantify the stabilizing effect of different devices. Through the combined use of the 3D motion analysis and the surface electromyography, the influence of the devices with respect to a mechanical effect and to an influence on the neuromuscular control are examined. The tests will simulate situations with a higher risk of injury. In the experimental set-up, an element of surprise will be integrated in order to analyze any muscular compensation mechanisms.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Heidelberg, Germany, 69118
        • Department of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic ankle instability
  • "giving way"
  • repeated ankle sprains

Exclusion Criteria:

  • other injuries of the lower extremities
  • surgery on the lower extremities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: taping the ankle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in elektromyographic signal in peroneus longus muscle (surface EMG)
Time Frame: baseline (=before) and immediately after applying the device
baseline (=before) and immediately after applying the device

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Benita Kuni, Dr. med., M.D., Dep. of Orthopedics, Trauma Surgery and Spinal Cord Injury

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (Estimate)

February 1, 2013

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 23, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 407- 05_121126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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