NCT01157663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

5 months

First QC Date

June 30, 2010

Last Update Submit

December 4, 2014

Conditions

Keywords

Functional ankle instability

Outcome Measures

Primary Outcomes (1)

  • effect of balance training on movement strategy

    kinematics, kinetics, plantar pressures and muscle activity

    after 8 weeks of treatment

Secondary Outcomes (3)

  • self-assessed complaints registration using questionnaires

    after 8 weeks

  • self-assessed complaints registration using questionnaires

    after 1 year

  • self-assessed complaints registration using questionnaires

    at baseline

Study Arms (2)

Adapted Balance Training group

EXPERIMENTAL
Other: Adapted balance training

Standard Balance training group

ACTIVE COMPARATOR

Balance training with unipedal standing during 8 weeks

Other: Balance Training

Interventions

during 8 weeks

Adapted Balance Training group

Balance training with unipedal standing during 8 weeks

Standard Balance training group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Ghent

Ghent, Belgium

Location

Study Officials

  • Philip Roosen, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 7, 2010

Study Start

December 1, 2010

Primary Completion

May 1, 2011

Study Completion

December 1, 2013

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations