- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01781351
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
Conditions
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
-
-
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Heidelberg, Germany, 69118
- Department of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital
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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.
Sponsor
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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