The Effect of Balance Training in People With Functional... | NCT01157663

Studies
The Effect of Balance Training in People With Functional Ankle Instability (FAI)

NCT01157663

Sponsor

University Ghent

Status

Completed

Last Update Posted

Dec 5, 2014Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Functional Ankle Instability

Interventions

Adapted balance training
Balance Training

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

Dec 2014

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

Dec 2010

Primary Completion Date

May 2011Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jun 30, 2010

First Submission Date that Met QC Criteria

Jul 6, 2010

First Posted Date

Jul 7, 2010Estimated

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

Dec 4, 2014

Last Update Posted Date

Dec 5, 2014Estimated

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

Ankle sprain is the most occurring sport related injury. In addition, 40% of the people who sustain such an injury display residual symptoms under the general denominator functional ankle instability (FAI). In literature, there is already given a lot of attention to extrinsic and intrinsic risk factors of FAI. Furthermore, there is a major focus on the possible interventions which may be able to reduce the chance of developing chronic instability. At this moment there is a lack of unequivocality.

In this study the investigators address the question of what is the effect of a balance training programme on the movement strategy. Therefore kinematics, kinetics, plantar pressure measurements and muscle activity are taken in consideration The purpose of this study is a better insight in the effect of treatment on the residual symptoms related to FAI.

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
Adapted Balance Training group	Experimental		Other: Adapted balance training
Standard Balance training group	Active Comparator	Balance training with unipedal standing during 8 weeks	Other: Balance Training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adapted balance training	Other	during 8 weeks	Adapted Balance Training group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
effect of balance training on movement strategy	kinematics, kinetics, plantar pressures and muscle activity	after 8 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
self-assessed complaints registration using questionnaires		after 8 weeks
self-assessed complaints registration using questionnaires		after 1 year
self-assessed complaints registration using questionnaires

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

a history of more than 1 unilateral ankle sprain
presence of feeling of 'giving way'
a feeling of weakness around the ankle
a decreased functional participation

Exclusion Criteria:

ankle fracture
ankle surgery
lower limb pain (not related to an ankle sprain)
ankle distortion in the last 3 months
currently receiving treatment
disturbance of equilibrium

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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
University Ghent		Ghent			Belgium