Ankle DiseaseAnkle-optogaNCT06318494
Analysis of Jumping in Patients With Ankle Instability (Ankle-optogait)
A study testing jumping performance in people with Ankle Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The study is, in accordance with current legislation, definable as a single-center interventional study with evaluations carried out at a single timeframe. The objective of the study is to compare jumping performance between subjects with ankle instability and healthy volunteer subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Disease
- What is being tested?
- jumping performance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 28 Apr 2022to Jul 2025
- 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
- Athletes of legal age (aged between 18 and 45 years inclusive) suffering from chronic ankle instability symptomatic of recurrent subjective and objective instability (study group).
- Athletes of legal age (aged between 18 and 45 years) who are not symptomatic for ankle diseases (control group)
- Signing of the Informed Consent and consent to collaborate in all study procedures.
Who cannot join
- Minors
- Pregnant women (self-declaration)
- patients with BMI ≥ 30
- patients with orthopaedic, muscular and neuromuscular problems at the time of performing the jump
- Non-acceptance of informed consent
- Patients with previous unilateral or contralateral ankle reconstructive surgery
Trial locations and contacts
1 site in 1 country.
About this study
The study is, in accordance with current legislation, definable as a single-center interventional study with evaluations carried out at a single timeframe.
The objective of the study is to compare jumping performance between subjects with ankle instability and healthy volunteer subjects.
Read more
In particular, the primary objective is to verify the difference in the monopodalic CMJ value of the diseased limb of subjects with ankle instability compared to the control group at time 0.
The population is made up of patients suffering from ankle instability and a control group of healthy volunteers, divided as follows:
25 subjects GROUP A: Study group: patients suffering from ankle instability
25 subjects GROUP B: control group: healthy voluntary subjects not affected by ankle pathology
Read the detailed description
Ankle sprains are one of the most common injuries during sports activity which often results in chronic instability of the ankle, characterized by a feeling of sagging more or less associated with pain with impairment of sports activity.
Numerous authors have suggested that there is altered peripheral neuromuscular control in patients with ankle instability with limitations related to proprioception, neuromuscular control, or strength, leading to deficits not only of the ankle joint but of the entire inferior kinetic chain Jumping is a simple gesture, present in almost every sporting activity, and its evaluation has proven to be a reliable parameter in terms of partisan capacity.
Patients suffering from chronic ankle instability symptomatic of recurrent subjective and objective instability will be considered. Patients will be compared to a control group of healthy volunteer subjects.
T0
- Explanation of the study and written informed consent.
- Verification of inclusion/exclusion criteria and verification of previous or ongoing treatments.
- AOFAS Rating Scales,
- Tegner activity level
- Vertical Jump Test (CMJ) using OptoGait platform using a battery of monopodalic jumps.
- Drop jump using an OptoGait platform using a battery of monopodalic jumps
- Side hop test using an OptoGait platform using a battery of monopod jumps
- Conditions
- Ankle Disease
- Being tested
- jumping performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
jumping performanceOther
Patients suffering from chronic ankle instability symptomatic of recurrent subjective and objective instability will be considered. Patients will be compared to a control group of healthy volunteer subjects.
T0 Explanation of the study and written informed consent.
- Verification of inclusion/exclusion criteria and verification of previous or ongoing treatments.
- AOFAS Rating Scales,
- Tegner activity level
- Vertical Jump Test (CMJ) by foot pedal
| Study group | Role | What they receive |
|---|---|---|
| Patients suffering from ankle instability | Experimental | Not described Receives: Other: jumping performance |
| Healthy volunteer subjects not affected by ankle pathology | Active comparator | Not described Receives: Other: jumping performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
verify the difference in the monopodalic CMJ (countermovement jump test) of the diseased limb of subjects with ankle instability compared to the control group
verify the difference in the monopodalic CMJ (countermovement jump test) value of the diseased limb of subjects with ankle instability compared to the control group at time 0
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start28 Apr 2022
- Primary completionJan 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle DiseaseStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318494
- Sponsor's protocol ID
- Ankle-optogait
- Acronym
- Ankle-optoga
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Jumping in Patients With Ankle Instability (Ankle-optogait)
- ClinicalTrials.gov ID
- NCT06318494
- Acronym / sponsor ID
- Ankle-optoga / Ankle-optogait
- Conditions
- Ankle Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 19 Mar 2024 (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 study is, in accordance with current legislation, definable as a single-center interventional study with evaluations carried out at a single timeframe.
The objective of the study is to compare jumping performance between subjects with ankle instability and healthy volunteer subjects.
In particular, the primary objective is to verify the difference in the monopodalic CMJ value of the diseased limb of subjects with ankle instability compared to the control group at time 0.
The population is made up of patients suffering from ankle instability and a control group of healthy volunteers, divided as follows:
25 subjects GROUP A: Study group: patients suffering from ankle instability
25 subjects GROUP B: control group: healthy voluntary subjects not affected by ankle pathology
Detailed description
Ankle sprains are one of the most common injuries during sports activity which often results in chronic instability of the ankle, characterized by a feeling of sagging more or less associated with pain with impairment of sports activity.
Numerous authors have suggested that there is altered peripheral neuromuscular control in patients with ankle instability with limitations related to proprioception, neuromuscular control, or strength, leading to deficits not only of the ankle joint but of the entire inferior kinetic chain Jumping is a simple gesture, present in almost every sporting activity, and its evaluation has proven to be a reliable parameter in terms of partisan capacity.
Patients suffering from chronic ankle instability symptomatic of recurrent subjective and objective instability will be considered. Patients will be compared to a control group of healthy volunteer subjects.
T0
- Explanation of the study and written informed consent.
- Verification of inclusion/exclusion criteria and verification of previous or ongoing treatments.
- AOFAS Rating Scales,
- Tegner activity level
- Vertical Jump Test (CMJ) using OptoGait platform using a battery of monopodalic jumps.
- Drop jump using an OptoGait platform using a battery of monopodalic jumps
- Side hop test using an OptoGait platform using a battery of monopod jumps
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients suffering from ankle instability | Experimental | Other: jumping performance |
| Healthy volunteer subjects not affected by ankle pathology | Active comparator | Other: jumping performance |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Athletes of legal age (aged between 18 and 45 years inclusive) suffering from chronic ankle instability symptomatic of recurrent subjective and objective instability (study group).
- Athletes of legal age (aged between 18 and 45 years) who are not symptomatic for ankle diseases (control group)
- Signing of the Informed Consent and consent to collaborate in all study procedures.
Key exclusion criteria (6 listed)
- Minors
- Pregnant women (self-declaration)
- patients with BMI ≥ 30
- patients with orthopaedic, muscular and neuromuscular problems at the time of performing the jump
- Non-acceptance of informed consent
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 |
|---|---|---|
| jumping performancePatients suffering from chronic ankle instability symptomatic of recurrent subjective and objective instability will be considered. Patients will be compared to a control group of healthy volunteer subjects. T0 Explanation of the study and written informed consent. * Verification of inclusion/exclusion criteria and verification of previous or ongoing treatments. * AOFAS Rating Scales, * Tegner activity level * Vertical Jump Test (CMJ) by foot pedal | Other | Healthy volunteer subjects not affected by ankle pathology, Patients suffering from ankle instability |
Primary outcome
verify the difference in the monopodalic CMJ (countermovement jump test) of the diseased limb of subjects with ankle instability compared to the control group
Time frame: Day 0
verify the difference in the monopodalic CMJ (countermovement jump test) value of the diseased limb of subjects with ankle instability compared to the control group at time 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing jumping performance in people with Ankle Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 19 Mar 2024. 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 Italy. 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?
verify the difference in the monopodalic CMJ (countermovement jump test) of the diseased limb of subjects with ankle instability compared to the control group (time frame: Day 0). 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 19 Mar 2024.