Chronic Ankle InstabilityKNEE-CAINCT05273177
Muscle Strength Assessment in Patients With Chronic Ankle Instability
An observational study of Chronic Ankle Instability, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Patients with chronic ankle instability (CAI) show biomechanical and neuromuscular alterations during the performance of functional movements not only at the ankle joint level, but also in more proximal joints and segments. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- Chronic ankle instability
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 28 Feb 2022to 28 Feb 2023
- Phase
- Observational
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Orthopaedic hospital and community individuals
Who may be able to join
- age between 18 and 40 years
- chronic ankle instability
- physically active individuals
Who cannot join
- sedentary behaviour
- previous injuries or surgeries to the lower limbs
- neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Valutazione Della Funzione Neuromuscolare Dei Muscoli Flessori ed Estensori Del Ginocchio in Pazienti Con instabilità Cronica di Caviglia (CAI)
Patients with chronic ankle instability (CAI) show biomechanical and neuromuscular alterations during the performance of functional movements not only at the ankle joint level, but also in more proximal joints and segments. Few studies have been conducted to investigate the effects of chronic ankle instability on neuromuscular control at the knee joint level. The aim of this study is to investigate whenther abnormalities exists in maximal and sub-maximal isometric muscle strength expression in patients with CAI.
- Conditions
- Chronic Ankle Instability
- Being tested
- Chronic ankle instability
- Keywords
- ankle instability, muscle strength, quadriceps, hamstrings, maximal voluntary isometric contraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic ankle instabilityOther
Persistent condition of ankle instability after a first ankle sprain episode.
| Study group | Role | What they receive |
|---|---|---|
| CAI group | Not described Receives: Other: Chronic ankle instability | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forces exerted by knee extensor and flexor muscles
The forces (N) exerted by knee extensor and flexor muscles will be assessed by means of a dynamometer during maximal and submaximal isometric muscle contractions.
Measured: Day 1
Secondary outcomes (1)
Knee extensor and flexor muscles activations
Knee extensor and flexor muscles activations (mV) during the maximal and submaximal isometric contractions will be recorded by means of surface electrodes for electromyography.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start28 Feb 2022
- Primary completion28 Jan 2023
- Study completion28 Feb 2023
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.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariagrazia Benedetti, Istituto Ortopedico Rizzoli
- Investigators
- Maria Grazia Benedetti, MD, Principal investigator, IRCCS Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273177
- Sponsor's protocol ID
- PG. 0002018_2021
- Acronym
- KNEE-CAI
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Labanca L, Tedeschi R, Mosca M, Benedetti MG. Individuals With Chronic Ankle Instability Show Abnormalities in Maximal and Submaximal Isometric Strength of the Knee Extensor and Flexor Muscles. Am J Sports Med. 2024 Apr;52(5):1328-1335. doi: 10.1177/03635465241232090. Epub 2024 Mar 8.
PubMed 38459686
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valutazione Della Funzione Neuromuscolare Dei Muscoli Flessori ed Estensori Del Ginocchio in Pazienti Con instabilità Cronica di Caviglia (CAI)
- ClinicalTrials.gov ID
- NCT05273177
- Acronym / sponsor ID
- KNEE-CAI / PG. 0002018_2021
- Conditions
- Chronic Ankle Instability
- Keywords
- ankle instability, muscle strength, quadriceps, hamstrings, maximal voluntary isometric contraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 10 Mar 2022 (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.
Patients with chronic ankle instability (CAI) show biomechanical and neuromuscular alterations during the performance of functional movements not only at the ankle joint level, but also in more proximal joints and segments. Few studies have been conducted to investigate the effects of chronic ankle instability on neuromuscular control at the knee joint level. The aim of this study is to investigate whenther abnormalities exists in maximal and sub-maximal isometric muscle strength expression in patients with CAI.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAI group | – | Other: Chronic ankle instability |
| Control group | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Orthopaedic hospital and community individuals
Key inclusion criteria (3 listed)
- age between 18 and 40 years
- chronic ankle instability
- physically active individuals
Key exclusion criteria (3 listed)
- sedentary behaviour
- previous injuries or surgeries to the lower limbs
- neurological disorders
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 |
|---|---|---|
| Chronic ankle instabilityPersistent condition of ankle instability after a first ankle sprain episode. | Other | CAI group |
Primary outcome
Forces exerted by knee extensor and flexor muscles
Time frame: Day 1
The forces (N) exerted by knee extensor and flexor muscles will be assessed by means of a dynamometer during maximal and submaximal isometric muscle contractions.
1 secondary outcome
Knee extensor and flexor muscles activations
Time frame: Day 1
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 Mar 2023.
- Derived from this study: PubMed 38459686Labanca L, Tedeschi R, Mosca M, Benedetti MG. Individuals With Chronic Ankle Instability Show Abnormalities in Maximal and Submaximal Isometric Strength of the Knee Extensor and Flexor Muscles. Am J Sports Med. 2024 Apr;52(5):1328-1335. doi: 10.1177/03635465241232090. Epub 2024 Mar 8.
- Individual participant dataSharing planned: Undecided
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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.
Maria Grazia Benedetti, MD principal investigator
IRCCS Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Ankle Instability, run by Istituto Ortopedico Rizzoli 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 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 Mar 2023. 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?
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?
Forces exerted by knee extensor and flexor muscles (time frame: Day 1). 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 NCT05273177, 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 1 Mar 2023.