Chronic Ankle InstabilityCAINCT01733433
Influence of Taping on Postural Control in Subjects With Chronic Ankle Instability
A study testing Taping the ankle in people with Chronic Ankle Instability, run by University Ghent at 1 site in Belgium.
Trial summary
The main goal of this study is to evaluate the effect of taping on postural control during dynamic exercises. 30 subjects with Chronic ankle instability (CAI) will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- Taping the ankle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2013to May 2015
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- a history of at least one ankle sprain which resulted in pain, swelling and stiffness, prohibiting participation in sport-, recreational or other activities for at least 3 weeks
- repeated ankle sprains
- presence of giving way
- feeling of weakness around the ankle
- a decreased functional participation (recreational, competitive or professionally)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Taping on Postural Control in Subjects With Chronic Ankle Instability (CAI).
The main goal of this study is to evaluate the effect of taping on postural control during dynamic exercises. 30 subjects with Chronic ankle instability (CAI) will be included in the study. Several questionnaires regarding anthropometric data, medical history, activity level and functional status will be filled in by the participants. Postural control will be measured using a force plate and an optoelectronic system to capture lower limb kinematics. Subjects will be asked to perform a forward hop, sideward hop and a vertical drop, and they have to maintain their balance for 10 seconds after landing. 5 good trials of each movement will be captured. Subjects with CAI will perform these exercises with and without tape. Hypothesis is that subjects with CAI that tape will enhance postural control.
- Conditions
- Chronic Ankle Instability
- Being tested
- Taping the ankle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taping the ankleProcedure or surgery
Subjects will be taped in at the ankle for performing several exercises.
| Study group | Role | What they receive |
|---|---|---|
| taped ankle | Experimental | Subjects will be taped in at the ankle for a series of exercises. Receives: Procedure: Taping the ankle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate postural control with tape on ankle.
Postural control will be measured using a force plate and an optoelectronic system to capture lower limb kinematics.
Measured: for 75 minutes, the duration of the exercises.
Secondary outcomes (3)
Subjective evaluation of the effect of taping on pain
Evaluation will be done using a VAS scale.
Measured: 1 minute after the exercises (which last approximately 75 minutes).
Subjective evaluation of the effect of taping on difficulty level.
This will be evaluated by interviewing the subject.
Measured: 1 minute after the exercises (which last approximately 75 minutes).
Subject evaluation of the effect of taping on instability feelings.
This will be evaluated by interviewing the subject.
Measured: 1 minute after the exercises (which last approximately 75 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startMar 2013
- Primary completionFeb 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- NCT01733433
- Sponsor's protocol ID
- 2012/480
- Acronym
- CAI
- Status last verified
- Nov 2021
- First submitted
- 13 Nov 2012
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Taping on Postural Control in Subjects With Chronic Ankle Instability (CAI).
- ClinicalTrials.gov ID
- NCT01733433
- Acronym / sponsor ID
- CAI / 2012/480
- Conditions
- Chronic Ankle Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Nov 2012 (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.
The main goal of this study is to evaluate the effect of taping on postural control during dynamic exercises. 30 subjects with Chronic ankle instability (CAI) will be included in the study. Several questionnaires regarding anthropometric data, medical history, activity level and functional status will be filled in by the participants. Postural control will be measured using a force plate and an optoelectronic system to capture lower limb kinematics. Subjects will be asked to perform a forward hop, sideward hop and a vertical drop, and they have to maintain their balance for 10 seconds after landing. 5 good trials of each movement will be captured. Subjects with CAI will perform these exercises with and without tape. Hypothesis is that subjects with CAI that tape will enhance postural control.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| taped ankle | Experimental | Procedure: Taping the ankleSubjects will be taped in at the ankle for a series of exercises. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- a history of at least one ankle sprain which resulted in pain, swelling and stiffness, prohibiting participation in sport-, recreational or other activities for at least 3 weeks
- repeated ankle sprains
- presence of giving way
- feeling of weakness around the ankle
- a decreased functional participation (recreational, competitive or professionally)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Taping the ankleSubjects will be taped in at the ankle for performing several exercises. | Procedure or surgery | taped ankle |
Primary outcome
Immediate postural control with tape on ankle.
Time frame: for 75 minutes, the duration of the exercises.
Postural control will be measured using a force plate and an optoelectronic system to capture lower limb kinematics.
3 secondary outcomes
Subjective evaluation of the effect of taping on pain
Time frame: 1 minute after the exercises (which last approximately 75 minutes).
Subjective evaluation of the effect of taping on difficulty level.
Time frame: 1 minute after the exercises (which last approximately 75 minutes).
Subject evaluation of the effect of taping on instability feelings.
Time frame: 1 minute after the exercises (which last approximately 75 minutes).
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 2 Dec 2021.
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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.
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 Taping the ankle in people with Chronic 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 5 inclusion and 0 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 2 Dec 2021. 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?
Immediate postural control with tape on ankle. (time frame: for 75 minutes, the duration of the exercises.). 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 2 Dec 2021.