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

Primary Purpose

Ankle Inversion Sprain, Instability, Joint, Treatment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Balance training
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Inversion Sprain

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Uni-axial

    Multidirectional

    Arm Description

    Subjects in this group perform exercises on an uni-axial balance board

    Subjects in this group perform exercises on a multidirectional balance board

    Outcomes

    Primary Outcome Measures

    muscle reaction time
    Muscle reaction of lower leg muscles is recorded during sudden simulated inversion sprain on a trap door

    Secondary Outcome Measures

    Full Information

    First Posted
    February 14, 2018
    Last Updated
    November 30, 2021
    Sponsor
    University Ghent
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03439930
    Brief Title
    The Effect of Balance Training on Neuromuscular Control in Subjects With CAI
    Official Title
    The Effect of Balance Training on Neuromuscular Control in Subjects With CAI
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2017 (Actual)
    Study Completion Date
    June 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Ghent

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankle Inversion Sprain, Instability, Joint, Treatment, Neuromuscular Control, Reaction Time

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Uni-axial
    Arm Type
    Active Comparator
    Arm Description
    Subjects in this group perform exercises on an uni-axial balance board
    Arm Title
    Multidirectional
    Arm Type
    Active Comparator
    Arm Description
    Subjects in this group perform exercises on a multidirectional balance board
    Intervention Type
    Other
    Intervention Name(s)
    Balance training
    Intervention Description
    6 weeks lasting balance training program
    Primary Outcome Measure Information:
    Title
    muscle reaction time
    Description
    Muscle reaction of lower leg muscles is recorded during sudden simulated inversion sprain on a trap door
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Roel De Ridder
    Organizational Affiliation
    University Ghent
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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