The Effect of Balance Training on Neuromuscular Control i... | NCT03439930

Studies
The Effect of Balance Training on Neuromuscular Control in Subjects With CAI

NCT03439930

Sponsor

University Ghent

Status

Completed

Last Update Posted

Dec 1, 2021Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Ankle Inversion Sprain
Instability, Joint
Treatment
Neuromuscular Control
Reaction Time

Interventions

Balance training

Countries

Not provided

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

Sep 1, 2016Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Jun 30, 2018Actual

First Submitted Date

Feb 14, 2018

First Submission Date that Met QC Criteria

Feb 14, 2018

First Posted Date

Feb 20, 2018Actual

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 30, 2021

Last Update Posted Date

Dec 1, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 goal of this study is evaluate the effect of uni-axial versus multidirectional balance training on muscle reaction time in subjects with chronic ankle instability. Muscle reaction time is measured on a trapdoor simulating an inversion sprain before and after a 6 week lasting balance training protocol.

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
Uni-axial	Active Comparator	Subjects in this group perform exercises on an uni-axial balance board	Other: Balance training
Multidirectional	Active Comparator	Subjects in this group perform exercises on a multidirectional balance board	Other: Balance training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Balance training	Other	6 weeks lasting balance training program	Multidirectional Uni-axial

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
muscle reaction time	Muscle reaction of lower leg muscles is recorded during sudden simulated inversion sprain on a trap door	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

According to the consensus statement of the International Ankle Consortium

Inclusion Criteria:

History of an ankle sprain
Repetitive ankle sprains AND feelings of instability AND giving way
Ankle functionality is documented (not as inclusion criteria)

Exclusion Criteria:

Fracture
Surgery
equilibrium disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Roel De Ridder	University Ghent	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007593	Joint Instability

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided