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Neuromuscular Control of the Ankle With External Support

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Dr. med. Benita Kuni, MD, University Hospital Heidelberg.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781351
First Posted: February 1, 2013
Last Update Posted: September 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. med. Benita Kuni, MD, University Hospital Heidelberg
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Further study details as provided by Dr. med. Benita Kuni, MD, 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 ]

Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: taping the ankle Other: Taping the ankle

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781351


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

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
First Submitted: January 15, 2013
First Posted: February 1, 2013
Last Update Posted: September 25, 2014
Last Verified: September 2014