Ankle Inversion SprainNCT03439930
The Effect of Balance Training on Neuromuscular Control in Subjects With CAI
A study testing Balance training in people with Ankle Inversion Sprain and Instability, Joint, run by University Ghent.
Trial summary
The goal of this study is evaluate the effect of uni-axial versus multidirectional balance training on muscle reaction time in subjects with chronic ankle instability. Muscle reaction time is measured on a trapdoor simulating an inversion sprain before and after a 6 week lasting balance training protocol. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Ankle Inversion Sprain, Instability, Joint, Treatment
- What is being tested?
- Balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 30 Jun 2018
- 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 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of an ankle sprain
- Repetitive ankle sprains AND feelings of instability AND giving way
- Ankle functionality is documented (not as inclusion criteria)
Who cannot join
- Fracture
- Surgery
- equilibrium disorder
About this study
The goal of this study is evaluate the effect of uni-axial versus multidirectional balance training on muscle reaction time in subjects with chronic ankle instability. Muscle reaction time is measured on a trapdoor simulating an inversion sprain before and after a 6 week lasting balance training protocol.
- Conditions
- Ankle Inversion Sprain, Instability, Joint, Treatment, Neuromuscular Control, Reaction Time
- Being tested
- Balance training
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance trainingOther
6 weeks lasting balance training program
| Study group | Role | What they receive |
|---|---|---|
| Uni-axial | Active comparator | Subjects in this group perform exercises on an uni-axial balance board Receives: Other: Balance training |
| Multidirectional | Active comparator | Subjects in this group perform exercises on a multidirectional balance board Receives: Other: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle reaction time
Muscle reaction of lower leg muscles is recorded during sudden simulated inversion sprain on a trap door
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start1 Sep 2016
- Primary completion31 Dec 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Inversion SprainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roel De Ridder, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439930
- Sponsor's protocol ID
- 2015/0711
- Status last verified
- Nov 2021
- First submitted
- 14 Feb 2018
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Balance Training on Neuromuscular Control in Subjects With CAI
- ClinicalTrials.gov ID
- NCT03439930
- Acronym / sponsor ID
- 2015/0711
- Conditions
- Ankle Inversion Sprain, Instability, Joint, Treatment, Neuromuscular Control, Reaction Time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 20 Feb 2018 (actual)
- 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.
The goal of this study is evaluate the effect of uni-axial versus multidirectional balance training on muscle reaction time in subjects with chronic ankle instability. Muscle reaction time is measured on a trapdoor simulating an inversion sprain before and after a 6 week lasting balance training protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uni-axial | Active comparator | Other: Balance trainingSubjects in this group perform exercises on an uni-axial balance board |
| Multidirectional | Active comparator | Other: Balance trainingSubjects in this group perform exercises on a multidirectional balance board |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- History of an ankle sprain
- Repetitive ankle sprains AND feelings of instability AND giving way
- Ankle functionality is documented (not as inclusion criteria)
Key exclusion criteria (3 listed)
- Fracture
- Surgery
- equilibrium disorder
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 |
|---|---|---|
| Balance training6 weeks lasting balance training program | Other | Multidirectional, Uni-axial |
Primary outcome
muscle reaction time
Time frame: 6 weeks
Muscle reaction of lower leg muscles is recorded during sudden simulated inversion sprain on a trap door
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 1 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Roel De Ridder principal investigator
University Ghent
Questions about this trial
What is this clinical trial studying?
A study testing Balance training in people with Ankle Inversion Sprain and Instability, Joint, run by University Ghent.
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 3 inclusion and 3 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 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
muscle reaction time (time frame: 6 weeks). 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 1 Dec 2021.