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CompletedNCT05273177KNEE-CAIUpdated Mar 1, 2023

Muscle Strength Assessment in Patients With Chronic Ankle Instability

An observational study in Chronic Ankle Instability, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by Istituto Ortopedico Rizzoli · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
30
Ages
18 Years to 40 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Ankle Instability

Keywords

  • ankle instability
  • muscle strength
  • quadriceps
  • hamstrings
  • maximal voluntary isometric contraction
03

In context

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 104 are open to participants now.

Browse Istituto Ortopedico Rizzoli studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Orthopaedic hospital and community individuals

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age between 18 and 40 years
  • chronic ankle instability
  • physically active individuals

Exclusion criteria

Exclusion Criteria:

  • sedentary behaviour
  • previous injuries or surgeries to the lower limbs
  • neurological disorders
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • CAI group

    Other: Chronic ankle instability

  • Control group

Interventions

  • OtherChronic ankle instability

    Persistent condition of ankle instability after a first ankle sprain episode.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Day 1

07

Study locations

1 site
  • Istituto Ortopedico Rizzoli
    Bologna, 40136, Italy
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2022 to primary completion in Jan 2023, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 17, 2022
First posted
Mar 10, 2022
StartActual
Feb 28, 2022
Primary completionActual
Jan 28, 2023
CompletionActual
Feb 28, 2023
Last update
Mar 1, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05273177
Lead sponsor
Istituto Ortopedico Rizzoli
Responsible party
Mariagrazia Benedetti (Professor, Istituto Ortopedico Rizzoli) — Principal investigator
First posted
Mar 10, 2022
Start date
Feb 28, 2022
Primary completion
Jan 28, 2023
Completion
Feb 28, 2023
Last update
Mar 1, 2023

Study contacts

Maria Grazia Benedetti, MD
principal investigator · IRCCS Istituto Ortopedico Rizzoli

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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