NCT01781351

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
28 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

January 15, 2013

Last Update Submit

September 23, 2014

Conditions

Chronic Ankle Instability

Outcome Measures

Primary Outcomes (1)

  • Change in elektromyographic signal in peroneus longus muscle (surface EMG)

    baseline (=before) and immediately after applying the device

Study Arms (1)

taping the ankle

EXPERIMENTAL
Other: Taping the ankle

Interventions

Taping the ankleOTHER
taping the ankle

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • chronic ankle instability
  • "giving way"
  • repeated ankle sprains

You may not qualify if:

  • other injuries of the lower extremities
  • surgery on the lower extremities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Heidelberg, 69118, Germany

Location

Study Officials

  • Benita Kuni, Dr. med., M.D.

    Dep. of Orthopedics, Trauma Surgery and Spinal Cord Injury

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med B. Kuni

Study Record Dates

First Submitted

January 15, 2013

First Posted

February 1, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2015

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

DE(1)