Neuromuscular Control of the Ankle With External Support

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University Hospital Heidelberg
Sponsor:
Information provided by (Responsible Party):
Dr. med. Benita Kuni, MD, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01781351
First received: January 15, 2013
Last updated: March 29, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Chronic Ankle Instability
Other: Taping the ankle

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Change in elektromyographic signal in peroneus longus muscle (surface EMG) [ Time Frame: baseline (=before) and immediately after applying the device ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: taping the ankle Other: Taping the ankle

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • other injuries of the lower extremities
  • surgery on the lower extremities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781351

Contacts
Contact: Benita Kuni, Dr. med. 00496221452343
Contact: Eva Kalkum, Dipl. biol. 004962215626728 eva.kalkum@med.uni-heidelberg.de

Locations
Germany
Department of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital Recruiting
Heidelberg, Germany, 69118
Contact: Benita Kuni, Dr.med.    +496221452343    benita@kuni.org   
Contact: Eva Kalkum, Dipl. biol.    +4962215626728    Eva.Kalkum@med.uni-heidelberg.de   
Principal Investigator: Benita Kuni, Dr. med.         
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
Principal Investigator: Benita Kuni, Dr. med., M.D. Dep. of Orthopedics, Trauma Surgery and Spinal Cord Injury
  More Information

No publications provided

Responsible Party: Dr. med. Benita Kuni, MD, Dr. med B. Kuni, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01781351     History of Changes
Other Study ID Numbers: 407- 05_121126
Study First Received: January 15, 2013
Last Updated: March 29, 2013
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on July 31, 2014