Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Neuromuscular Control of the Ankle With External Support

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Dr. med. Benita Kuni, MD, University Hospital Heidelberg Identifier:
First received: January 15, 2013
Last updated: September 23, 2014
Last verified: September 2014
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: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: taping the ankle Other: Taping the ankle


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01781351

Department of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital
Heidelberg, Germany, 69118
Sponsors and Collaborators
University Hospital Heidelberg
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 Identifier: NCT01781351     History of Changes
Other Study ID Numbers: 407- 05_121126 
Study First Received: January 15, 2013
Last Updated: September 23, 2014
Health Authority: Germany: Ethics Commission processed this record on January 18, 2017