Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT06318494 |
Other study ID # |
Ankle-optogait |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 28, 2022 |
Est. completion date |
July 2025 |
Study information
Verified date |
March 2024 |
Source |
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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
Description:
Ankle sprains are one of the most common injuries during sports activity which often results
in chronic instability of the ankle, characterized by a feeling of sagging more or less
associated with pain with impairment of sports activity.
Numerous authors have suggested that there is altered peripheral neuromuscular control in
patients with ankle instability with limitations related to proprioception, neuromuscular
control, or strength, leading to deficits not only of the ankle joint but of the entire
inferior kinetic chain Jumping is a simple gesture, present in almost every sporting
activity, and its evaluation has proven to be a reliable parameter in terms of partisan
capacity.
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) using OptoGait platform using a battery of monopodalic jumps.
- Drop jump using an OptoGait platform using a battery of monopodalic jumps
- Side hop test using an OptoGait platform using a battery of monopod jumps