Functional Ankle InstabilityNCT01157663
The Effect of Balance Training in People With Functional Ankle Instability (FAI)
A study testing Adapted balance training and Balance Training in people with Functional Ankle Instability, run by University Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Ankle Instability
- What is being tested?
- Adapted balance training and Balance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Functional Ankle Instability
- Being tested
- Adapted balance training, Balance Training
- Keywords
- Functional ankle instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted balance trainingOther
during 8 weeks
Balance TrainingOther
Balance training with unipedal standing during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Adapted Balance Training group | Experimental | Not described Receives: Other: Adapted balance training |
| Standard Balance training group | Active comparator | Balance training with unipedal standing during 8 weeks Receives: Other: Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of balance training on movement strategy
kinematics, kinetics, plantar pressures and muscle activity
Measured: after 8 weeks of treatment
Secondary outcomes (3)
self-assessed complaints registration using questionnaires
Measured: after 8 weeks
self-assessed complaints registration using questionnaires
Measured: after 1 year
self-assessed complaints registration using questionnaires
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startDec 2010
- Primary completionMay 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Ankle InstabilityStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip Roosen, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157663
- Sponsor's protocol ID
- 2010/345
- Status last verified
- Dec 2014
- First submitted
- 30 Jun 2010
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Balance Training in People With Functional Ankle Instability
- ClinicalTrials.gov ID
- NCT01157663
- Acronym / sponsor ID
- 2010/345
- Conditions
- Functional Ankle Instability
- Keywords
- Functional ankle instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted Balance Training group | Experimental | Other: Adapted balance training |
| Standard Balance training group | Active comparator | Other: Balance TrainingBalance training with unipedal standing during 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- ankle fracture
- ankle surgery
- lower limb pain (not related to an ankle sprain)
- ankle distortion in the last 3 months
- currently receiving treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted balance trainingduring 8 weeks | Other | Adapted Balance Training group |
| Balance TrainingBalance training with unipedal standing during 8 weeks | Other | Standard Balance training group |
Primary outcome
effect of balance training on movement strategy
Time frame: after 8 weeks of treatment
kinematics, kinetics, plantar pressures and muscle activity
3 secondary outcomes
self-assessed complaints registration using questionnaires
Time frame: after 8 weeks
self-assessed complaints registration using questionnaires
Time frame: after 1 year
self-assessed complaints registration using questionnaires
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
Related trials for Functional Ankle Instability
Recruiting
Neurocognitive Enrichment During Functional Performance Testing in Chronic Ankle Instability
Chronic Ankle Instability, CAI
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Recruiting
Functional Biomechanical Analysis in Patients Who Underwent Lateral Ankle Ligament Repair With Augmentation
Chronic Lateral Ankle Instability
Recruiting
Comparison of the Effects of Hip and Ankle Focused Progressive Exercise Training on Lower Extremity Function in Athletes With Chronic Ankle Instability
Ankle Sprains
Recruiting
Effect of Core Stability Training With Foot Exercises in Chronic Ankle Instability Patients
Instability, Joint
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Roosen, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted balance training and Balance Training in people with Functional Ankle Instability, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of balance training on movement strategy (time frame: after 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.