NCT05273177

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

February 28, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

February 17, 2022

Last Update Submit

February 28, 2023

Conditions

Chronic Ankle Instability

Keywords

ankle instabilitymuscle strengthquadricepshamstringsmaximal voluntary isometric contraction

Outcome Measures

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.

    Day 1

Secondary Outcomes (1)

  • Knee extensor and flexor muscles activations

    Day 1

Study Arms (2)

CAI group

Other: Chronic ankle instability

Control group

Interventions

Chronic ankle instabilityOTHER

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

CAI group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Orthopaedic hospital and community individuals

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (1)

  • 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.

    PMID: 38459686DERIVED

Study Officials

  • Maria Grazia Benedetti, MD

    IRCCS Istituto Ortopedico Rizzoli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 17, 2022

First Posted

March 10, 2022

Study Start

February 28, 2022

Primary Completion

January 28, 2023

Study Completion

February 28, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

IT(1)