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NCT01781351 Clinical Trial

Neuromuscular Control of the Ankle With External Support

Chronic Ankle Instability Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01781351
Other study ID # 407- 05_121126
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 15, 2013
Last updated September 23, 2014
Start date March 2013

Study information
Verified date September 2014
Source University Hospital Heidelberg
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- chronic ankle instability

- "giving way"

- repeated ankle sprains

Exclusion Criteria:

- other injuries of the lower extremities

- surgery on the lower extremities

Study Design

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

Related Conditions & MeSH terms

Intervention

Other:
• Taping the ankle

Locations
Country Name City State
Germany Department of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in elektromyographic signal in peroneus longus muscle (surface EMG) baseline (=before) and immediately after applying the device No
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