Analysis of Jumping in Patients With Ankle Instability (Ankle-optogait)

NCT06318494 | Active Not Recruiting

• 1 other identifier: Ankle-optogait
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Ankle Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Day 0

Study Arms (2)

Patients suffering from ankle instability

EXPERIMENTAL

Other: jumping performance

Healthy volunteer subjects not affected by ankle pathology

ACTIVE COMPARATOR

Other: jumping performance

Interventions

jumping performance OTHER

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

Healthy volunteer subjects not affected by ankle pathology; Patients suffering from ankle instability

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

Istituto Clinico San Siro

Milan, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 19, 2024
• Study Start: April 28, 2022
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)