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NCT01810471 Clinical Trial

External Ankle Supports - 3D Motion Analysis

Chronic Ankle Instability Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01810471
Other study ID # 407- 05_130307
Secondary ID
Status Completed
Phase N/A
First received March 10, 2013
Last updated March 13, 2013
Start date February 2010
Est. completion date December 2010

Study information
Verified date March 2013
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 use of a foot measurement model in 3D motion analysis the influence of the devices with respect to a mechanical effect is examined by means of different tests. The dynamic postural control is quantified. The hypothesis was that the devices would stabilize differently the foot segments.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2010
Est. primary completion date December 2010
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

Device:
• Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM)

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 of the range of motion of the subtalar inversion/eversion in degree baseline (=before) and immediately after applying the device No
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