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
About this trial
This is an interventional treatment trial for Ankle Inversion Sprain
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
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
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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