NCT01810471

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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
Last Updated

March 14, 2013

Status Verified

March 1, 2013

Enrollment Period

10 months

First QC Date

March 10, 2013

Last Update Submit

March 13, 2013

Conditions

Chronic Ankle Instability

Outcome Measures

Primary Outcomes (1)

  • change of the range of motion of the subtalar inversion/eversion in degree

    baseline (=before) and immediately after applying the device

Study Arms (1)

ankle supports

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

Interventions

Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM)DEVICE
ankle supports

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

Related Publications (1)

  • Kuni B, Mussler J, Kalkum E, Schmitt H, Wolf SI. Effect of kinesiotaping, non-elastic taping and bracing on segmental foot kinematics during drop landing in healthy subjects and subjects with chronic ankle instability. Physiotherapy. 2016 Sep;102(3):287-93. doi: 10.1016/j.physio.2015.07.004. Epub 2015 Sep 3.

    PMID: 26422550DERIVED

MeSH Terms

Interventions

Athletic Tape

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

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
Principal Investigator, Job Title: Orthopedic and Trauma Surgeon

Study Record Dates

First Submitted

March 10, 2013

First Posted

March 13, 2013

Study Start

February 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 14, 2013

Record last verified: 2013-03

Locations

DE(1)