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

November 30, 2021 updated by: University Ghent
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Uni-axial
Subjects in this group perform exercises on an uni-axial balance board
6 weeks lasting balance training program
ACTIVE_COMPARATOR: Multidirectional
Subjects in this group perform exercises on a multidirectional balance board
6 weeks lasting balance training program

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

June 30, 2018

Study Registration Dates

First Submitted

February 14, 2018

First Submitted That Met QC Criteria

February 14, 2018

First Posted (ACTUAL)

February 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 30, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2015/0711

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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