An interventional study of isokinetic test and Ballistic test in Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, sponsored by Almaviva Sante. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Almaviva Sante · Not applicable, Interventional, and Other
During physical activities, the time available to produce a force is infinitely shorter than the time required to reach maximal muscle capacity.
Previous studies have observed that the time elapsed between ground contact and ACL rupture is on average 50-60 ms, suggesting that this is the time window available for any attempt at dynamic stabilization of the joint through muscle contraction.
Sports movements include ballistic movements, defined as very fast movements whose objective is to accelerate a moving mass as much as possible so that it reaches a high speed in a very short time. This is the case for vertical jumps, running and most movements performed in physical and sporting activities.
Thus; (1) isokinetic tests do not allow a rigorous analysis of the components related to the speed of the movement; (2) functional tests such as jumping, which only give a distance between one leg and the other, do not allow the calculation of precise and reproducible variables concerning the force and speed of the movement, in particular during the first milliseconds of the movement, and do not provide information on compensation phenomena. It is therefore interesting to use the ballistic tests developed to monitor the movements of athletes as a new possible indicator of the return to sport.
The main objective of this study is to evaluate the performance of ballistic tests in predicting failure to return to physical activity 24 months after ACL surgery.
625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.
This study's planned enrollment of 140 is above the median of 56 across 458 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →Almaviva Sante is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Patient who has undergone ACL reconstruction of the hamstrings with or without associated extra-articular plastic surgery:
Exclusion Criteria:
Other: isokinetic test · Other: Ballistic test · Other: K-STARTS test · Other: Questionnaires
Bilateral strength will be measured using a Contrex ® dynamometer equipped with an exercise table. Each subject will perform isokinetic tests of the right and left knee extensors and flexors. Subjects will be stabilized by straps during testing and the joint rotation axis will be aligned with the input shaft of the dynamometer.
ballistic squat jumps performed in the supine position on a frictionless sled at a resistance between 0% of body weight (BW)
The K-STARTS (Knee Health Athletic Return To Sport) test brings together a set of 7 tests validated in the scientific literature to assess the control and neuromuscular capacities of the lower limb when performing dynamic movements as well as apprehension when resuming activity. Test in 30 minutes with physical exercises and questionnaire.
KOOS (Knee Injury and Osteoarthritis Outcome Score) Questionnaire
Analysis of the kinetics of force waves produced at high speed during ballistic movement
Analysis of the kinetics of force waves produced at high speed during a ballistic movement will make it possible to determine the ability to resume physical activity at a level similar to that before the rupture in the absence of injury (risk = 2.3 / no risk = 0.1). Failure to resume physical activity 24 months after ACL surgery is defined by the occurrence of one of the following events: * Graft rupture, * Contralateral ACL rupture, * Decrease of at least 2 points in the Tegner 24 months after cruciate ligament surgery compared to the Tegner before the rupture
Time frame: 24 Months
Return to physical activity via isokinetic test
Fitness to resume physical activity via isokinetic test will be determined by quadriceps torque values (\>3.0 Nm/kg) and an LSI\>90%.
Time frame: 24 Months
Return to physical activity via the K-STARTS test
Fitness to resume physical activity via the K-STARTS test will be determined by a total score ≥ 18 points and individual results of the tests comprising the K-START between 2 and 3.
Time frame: 24 Months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2024; primary completion for Dec 2026, 24 months later.
Of 277 non-industry interventional studies with no phase under Anterior Cruciate Ligament Injuries, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 70. This study's planned 24 months is below that.
Counting every sponsor, half of 286 studies reached it within 30 months; a quarter within 14 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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