The Effect of Balance Training in People With Functional Ankle Instability (FAI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01157663
First received: June 30, 2010
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Functional Ankle Instability
Other: Adapted balance training
Other: Balance Training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Balance Training in People With Functional Ankle Instability

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • effect of balance training on movement strategy [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]
    kinematics, kinetics, plantar pressures and muscle activity


Secondary Outcome Measures:
  • self-assessed complaints registration using questionnaires [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • self-assessed complaints registration using questionnaires [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
  • self-assessed complaints registration using questionnaires [ Time Frame: at baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adapted Balance Training group Other: Adapted balance training
during 8 weeks
Active Comparator: Standard Balance training group
Balance training with unipedal standing during 8 weeks
Other: Balance Training
Balance training with unipedal standing during 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157663

Locations
Belgium
University Ghent
Ghent, Belgium
Sponsors and Collaborators
University Ghent
Investigators
Principal Investigator: Philip Roosen, PhD University Ghent
  More Information

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01157663     History of Changes
Other Study ID Numbers: 2010/345
Study First Received: June 30, 2010
Last Updated: July 19, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by University Ghent:
Functional ankle instability

ClinicalTrials.gov processed this record on April 17, 2014