Muscle Strength Assessment in Patients With Chronic Ankle Instability (KNEE-CAI)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Ankle Instability
• Intervention / Treatment: Other: Chronic ankle instability

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

• Study Contact: Name: Maria Grazia Benedetti, MD; Phone Number: +39 051 6366236; Email: mariagrazia.benedetti@ior.it
• Study Contact Backup: Name: Clinical Trial Center; Phone Number: +39 051 636 6797

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Orthopaedic hospital and community individuals

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group
CAI group	Other: Chronic ankle instability; Persistent condition of ankle instability after a first ankle sprain episode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: Maria Grazia Benedetti, MD, IRCCS Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): January 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: muscle strength; hamstrings; quadriceps; ankle instability; maximal voluntary isometric contraction
• Other Study ID Numbers: PG. 0002018_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No