- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01157663
The Effect of Balance Training in People With Functional Ankle Instability (FAI)
The Effect of Balance Training in People With Functional Ankle Instability
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ghent, Belgium
- University Ghent
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adapted Balance Training group
|
during 8 weeks
|
|
Active Comparator: Standard Balance training group
Balance training with unipedal standing during 8 weeks
|
Balance training with unipedal standing during 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
effect of balance training on movement strategy
Time Frame: after 8 weeks of treatment
|
kinematics, kinetics, plantar pressures and muscle activity
|
after 8 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
self-assessed complaints registration using questionnaires
Time Frame: after 8 weeks
|
after 8 weeks
|
|
self-assessed complaints registration using questionnaires
Time Frame: after 1 year
|
after 1 year
|
|
self-assessed complaints registration using questionnaires
Time Frame: at baseline
|
at baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philip Roosen, PhD, University Ghent
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010/345
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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