The Effect of Balance Training in People With Functional Ankle Instability (FAI)
Primary Purpose
Functional Ankle Instability
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Adapted balance training
Balance Training
Sponsored by
About this trial
This is an interventional treatment trial for Functional Ankle Instability focused on measuring Functional ankle instability
Eligibility Criteria
Inclusion Criteria:
- a history of more than 1 unilateral ankle sprain
- presence of feeling of 'giving way'
- a feeling of weakness around the ankle
- a decreased functional participation
Exclusion Criteria:
- ankle fracture
- ankle surgery
- lower limb pain (not related to an ankle sprain)
- ankle distortion in the last 3 months
- currently receiving treatment
- disturbance of equilibrium
Sites / Locations
- University Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Adapted Balance Training group
Standard Balance training group
Arm Description
Balance training with unipedal standing during 8 weeks
Outcomes
Primary Outcome Measures
effect of balance training on movement strategy
kinematics, kinetics, plantar pressures and muscle activity
Secondary Outcome Measures
self-assessed complaints registration using questionnaires
self-assessed complaints registration using questionnaires
self-assessed complaints registration using questionnaires
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01157663
Brief Title
The Effect of Balance Training in People With Functional Ankle Instability (FAI)
Official Title
The Effect of Balance Training in People With Functional Ankle Instability
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ankle sprain is the most occurring sport related injury. In addition, 40% of the people who sustain such an injury display residual symptoms under the general denominator functional ankle instability (FAI). In literature, there is already given a lot of attention to extrinsic and intrinsic risk factors of FAI. Furthermore, there is a major focus on the possible interventions which may be able to reduce the chance of developing chronic instability. At this moment there is a lack of unequivocality.
In this study the investigators address the question of what is the effect of a balance training programme on the movement strategy. Therefore kinematics, kinetics, plantar pressure measurements and muscle activity are taken in consideration The purpose of this study is a better insight in the effect of treatment on the residual symptoms related to FAI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Ankle Instability
Keywords
Functional ankle instability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adapted Balance Training group
Arm Type
Experimental
Arm Title
Standard Balance training group
Arm Type
Active Comparator
Arm Description
Balance training with unipedal standing during 8 weeks
Intervention Type
Other
Intervention Name(s)
Adapted balance training
Intervention Description
during 8 weeks
Intervention Type
Other
Intervention Name(s)
Balance Training
Intervention Description
Balance training with unipedal standing during 8 weeks
Primary Outcome Measure Information:
Title
effect of balance training on movement strategy
Description
kinematics, kinetics, plantar pressures and muscle activity
Time Frame
after 8 weeks of treatment
Secondary Outcome Measure Information:
Title
self-assessed complaints registration using questionnaires
Time Frame
after 8 weeks
Title
self-assessed complaints registration using questionnaires
Time Frame
after 1 year
Title
self-assessed complaints registration using questionnaires
Time Frame
at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a history of more than 1 unilateral ankle sprain
presence of feeling of 'giving way'
a feeling of weakness around the ankle
a decreased functional participation
Exclusion Criteria:
ankle fracture
ankle surgery
lower limb pain (not related to an ankle sprain)
ankle distortion in the last 3 months
currently receiving treatment
disturbance of equilibrium
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Roosen, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Ghent
City
Ghent
Country
Belgium
12. IPD Sharing Statement
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The Effect of Balance Training in People With Functional Ankle Instability (FAI)
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