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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01157663
Other study ID # 2010/345
Secondary ID
Status Completed
Phase N/A
First received June 30, 2010
Last updated December 4, 2014
Start date December 2010
Est. completion date December 2013

Study information

Verified date December 2014
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2013
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Adapted balance training
during 8 weeks
Balance Training
Balance training with unipedal standing during 8 weeks

Locations

Country Name City State
Belgium University Ghent Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary effect of balance training on movement strategy kinematics, kinetics, plantar pressures and muscle activity after 8 weeks of treatment No
Secondary self-assessed complaints registration using questionnaires after 8 weeks No
Secondary self-assessed complaints registration using questionnaires after 1 year No
Secondary self-assessed complaints registration using questionnaires at baseline No