Chronic Ankle InstabilityNCT01781351
Neuromuscular Control of the Ankle With External Support
A study testing Taping the ankle 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 combined use of the 3D motion analysis and the surface electromyography, the influence of the devices with respect to a mechanical effect and… 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?
- Taping the ankle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Mar 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 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 combined use of the 3D motion analysis and the surface electromyography, the influence of the devices with respect to a mechanical effect and to an influence on the neuromuscular control are examined. The tests will simulate situations with a higher risk of injury. In the experimental set-up, an element of surprise will be integrated in order to analyze any muscular compensation mechanisms.
- 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 ankleOther
| Study group | Role | What they receive |
|---|---|---|
| taping the ankle | Experimental | Not described Receives: Other: Taping the ankle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in elektromyographic signal in peroneus longus muscle (surface EMG)
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 posted1 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015 (estimated)
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 Hospital HeidelbergThe 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
- 50 participants (estimated)
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
- NCT01781351
- Sponsor's protocol ID
- 407- 05_121126
- Status last verified
- Sep 2014
- First submitted
- 15 Jan 2013
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Control of the Ankle With External Support
- ClinicalTrials.gov ID
- NCT01781351
- Acronym / sponsor ID
- 407- 05_121126
- Conditions
- Chronic Ankle Instability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (estimated)
- First posted
- 1 Feb 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 combined use of the 3D motion analysis and the surface electromyography, the influence of the devices with respect to a mechanical effect and to an influence on the neuromuscular control are examined. The tests will simulate situations with a higher risk of injury. In the experimental set-up, an element of surprise will be integrated in order to analyze any muscular compensation mechanisms.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| taping the ankle | Experimental | Other: Taping the ankle |
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 |
|---|---|---|
| Taping the ankle | Other | taping the ankle |
Primary outcome
Change in elektromyographic signal in peroneus longus muscle (surface EMG)
Time frame: baseline (=before) and immediately after applying the device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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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 Taping the ankle 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: status not confirmed, as of the sponsor's last update on 25 Sep 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 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?
Results are not available in the source record.
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 in elektromyographic signal in peroneus longus muscle (surface EMG) (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?
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 25 Sep 2014.