Influence of Taping on Postural Control in Subjects With... | NCT01733433

Studies
Influence of Taping on Postural Control in Subjects With Chronic Ankle Instability

NCT01733433

Sponsor

University Ghent

Status

Completed

Last Update Posted

Dec 2, 2021Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Chronic Ankle Instability

Interventions

Taping the ankle

Countries

Belgium

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

Nov 2021

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

Mar 2013Actual

Primary Completion Date

Feb 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Nov 13, 2012

First Submission Date that Met QC Criteria

Nov 20, 2012

First Posted Date

Nov 27, 2012Estimated

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

Nov 19, 2021

Last Update Posted Date

Dec 2, 2021Actual

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

The main goal of this study is to evaluate the effect of taping on postural control during dynamic exercises. 30 subjects with Chronic ankle instability (CAI) will be included in the study. Several questionnaires regarding anthropometric data, medical history, activity level and functional status will be filled in by the participants. Postural control will be measured using a force plate and an optoelectronic system to capture lower limb kinematics. Subjects will be asked to perform a forward hop, sideward hop and a vertical drop, and they have to maintain their balance for 10 seconds after landing. 5 good trials of each movement will be captured. Subjects with CAI will perform these exercises with and without tape. Hypothesis is that subjects with CAI that tape will enhance postural control.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
taped ankle	Experimental	Subjects will be taped in at the ankle for a series of exercises.	Procedure: Taping the ankle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Taping the ankle	Procedure	Subjects will be taped in at the ankle for performing several exercises.	taped ankle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immediate postural control with tape on ankle.	Postural control will be measured using a force plate and an optoelectronic system to capture lower limb kinematics.	for 75 minutes, the duration of the exercises.

Secondary Outcomes

Measure	Description	Time Frame
Subjective evaluation of the effect of taping on pain	Evaluation will be done using a VAS scale.	1 minute after the exercises (which last approximately 75 minutes).
Subjective evaluation of the effect of taping on difficulty level.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

a history of at least one ankle sprain which resulted in pain, swelling and stiffness, prohibiting participation in sport-, recreational or other activities for at least 3 weeks
repeated ankle sprains
presence of giving way
feeling of weakness around the ankle
a decreased functional participation (recreational, competitive or professionally)

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philip Roosen, PhD	University Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghent University		Ghent		9000	Belgium