External Ankle Supports - 3D Motion Analysis | NCT01810471

Studies
External Ankle Supports - 3D Motion Analysis

NCT01810471

Sponsor

University Hospital Heidelberg

Status

Completed

Last Update Posted

Mar 14, 2013Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Chronic Ankle Instability

Interventions

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

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Mar 10, 2013

First Submission Date that Met QC Criteria

Mar 12, 2013

First Posted Date

Mar 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2013

Last Update Posted Date

Mar 14, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. med. Benita Kuni, MD, Principal Investigator, Job Title: Orthopedic and Trauma Surgeon, University Hospital HeidelbergPrincipal Investigator

Lead Sponsor

University Hospital HeidelbergOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ankle supports	Experimental		Device: Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM)	Device		ankle supports

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of the range of motion of the subtalar inversion/eversion in degree		baseline (=before) and immediately after applying the device

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

chronic ankle instability
"giving way"
repeated ankle sprains

Exclusion Criteria:

other injuries of the lower extremities
surgery on the lower extremities

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benita Kuni, Dr. med., M.D.	Dep. of Orthopedics, Trauma Surgery and Spinal Cord Injury	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital		Heidelberg		69118	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26422550	Derived	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.

ID	Term
D001458	Bandages
D004864	Equipment and Supplies
D009989	Orthotic Devices
D009983	Orthopedic Equipment