Chronic Ankle InstabilityNCT01810471
External Ankle Supports - 3D Motion Analysis
A study testing Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM) in people with Chronic Ankle Instability, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim of our study is to quantify the stabilizing effect of different devices. Through the use of a foot measurement model in 3D motion analysis the influence of the devices with respect to a mechanical effect is examined by means… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Dec 2010
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- chronic ankle instability
- "giving way"
- repeated ankle sprains
Who cannot join
- other injuries of the lower extremities
- surgery on the lower extremities
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital
Heidelberg, 69118
About this study
Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim of our study is to quantify the stabilizing effect of different devices. Through the use of a foot measurement model in 3D motion analysis the influence of the devices with respect to a mechanical effect is examined by means of different tests. The dynamic postural control is quantified. The hypothesis was that the devices would stabilize differently the foot segments.
- Conditions
- Chronic Ankle Instability
- Being tested
- Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM)Device
| Study group | Role | What they receive |
|---|---|---|
| ankle supports | Experimental | Not described Receives: Device: Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the range of motion of the subtalar inversion/eversion in degree
Measured: baseline (=before) and immediately after applying the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Benita Kuni, MD, University Hospital Heidelberg
- Investigators
- Benita Kuni, Dr. med., M.D., Principal investigator, Dep. of Orthopedics, Trauma Surgery and Spinal Cord Injury
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810471
- Sponsor's protocol ID
- 407- 05_130307
- Status last verified
- Mar 2013
- First submitted
- 10 Mar 2013
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuni B, Mussler J, Kalkum E, Schmitt H, Wolf SI. Effect of kinesiotaping, non-elastic taping and bracing on segmental foot kinematics during drop landing in healthy subjects and subjects with chronic ankle instability. Physiotherapy. 2016 Sep;102(3):287-93. doi: 10.1016/j.physio.2015.07.004. Epub 2015 Sep 3.
PubMed 26422550
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Ankle Supports - 3D Motion Analysis
- ClinicalTrials.gov ID
- NCT01810471
- Acronym / sponsor ID
- 407- 05_130307
- Conditions
- Chronic Ankle Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Mar 2013 (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.
Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim of our study is to quantify the stabilizing effect of different devices. Through the use of a foot measurement model in 3D motion analysis the influence of the devices with respect to a mechanical effect is examined by means of different tests. The dynamic postural control is quantified. The hypothesis was that the devices would stabilize differently the foot segments.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ankle supports | Experimental | Device: Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- chronic ankle instability
- "giving way"
- repeated ankle sprains
Key exclusion criteria (2 listed)
- other injuries of the lower extremities
- surgery on the lower extremities
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 |
|---|---|---|
| Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM) | Device | ankle supports |
Primary outcome
change of the range of motion of the subtalar inversion/eversion in degree
Time frame: baseline (=before) and immediately after applying the device
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 14 Mar 2013.
- Derived from this study: PubMed 26422550Kuni B, Mussler J, Kalkum E, Schmitt H, Wolf SI. Effect of kinesiotaping, non-elastic taping and bracing on segmental foot kinematics during drop landing in healthy subjects and subjects with chronic ankle instability. Physiotherapy. 2016 Sep;102(3):287-93. doi: 10.1016/j.physio.2015.07.004. Epub 2015 Sep 3.
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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.
Benita Kuni, Dr. med., M.D. principal investigator
Dep. of Orthopedics, Trauma Surgery and Spinal Cord Injury
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM) in people with Chronic Ankle Instability, run by University Hospital Heidelberg at 1 site in Germany.
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 2 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 14 Mar 2013. 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 Germany. 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?
change of the range of motion of the subtalar inversion/eversion in degree (time frame: baseline (=before) and immediately after applying the device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01810471, which also lists 1 linked publication.
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 14 Mar 2013; AzTrials last refreshed its copy on 27 Oct 2026.