- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03439930
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
Status
Completed
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
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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