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Not yet recruiting NCT07389850

Evaluation of the Evolution of Proprioceptive Reweighting Abilities Following Anterior Cruciate Ligament Reconstruction Surgery

No phase Interventional Anterior Cruciate Ligament Rupture With Ligamentoplasty

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In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ReproEVO intervention.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament Rupture With Ligamentoplasty. Basic parameters: 15 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of the Evolution of Proprioceptive Reweighting Abilities Following Anterior Cruciate Ligament Reconstruction Surgery - ReproEVO

Overview

Anterior cruciate ligament (ACL) injury is the most common knee injury among athletes who play contact sports involving pivoting. ACL reconstruction (ACLR) combined with rehabilitation is the standard treatment for ACL tears in athletes, and rehabilitation is one of the keys to success. The overall return to sport rate is 80%, but the return to pre-injury level of sport is only 65% and the return to the same level of competition is only 55%. The recurrence rate is close to 20%. During rehabilitation and sports practice, proprioceptive information is essential for adjusting the muscle sensorimotor loop and enabling optimal movement. Athletes can thus be classified as plastic or rigid . Our hypothesis is to show that the proportion of "plastic" patients 9 months post-operative following ACL reconstruction is higher than that found in the same population 3 months post-operative, thus demonstrating the progression of proprioceptive integration abilities after ACL reconstruction surgery.

Detailed description

Anterior cruciate ligament (ACL) injury is the most common knee injury among athletes who play contact sports involving pivoting. ACL reconstruction (ACLR) combined with rehabilitation is the standard treatment for ACL tears in athletes, and rehabilitation is one of the keys to success. The overall return to sport rate is 80%, but the return to pre-injury level of sport is only 65% and the return to the same level of competition is only 55%. The recurrence rate is close to 20%. Although the number of studies on the subject is growing, there is currently no consensus on rehabilitation protocols.

During rehabilitation and sports practice, proprioceptive information is essential for adjusting the muscle sensorimotor loop and enabling optimal movement.

We have demonstrated that athletes and athletes after ACL reconstruction show variability in the integration of proprioceptive information during a complex balance task.

Athletes can thus be classified as plastic (able to vary the source of proprioceptive information depending on conditions) or rigid (unable to do so).

Our hypothesis is to show that the proportion of "plastic" patients 9 months post-operative following ACL reconstruction is higher than that found in the same population 3 months post-operative, thus demonstrating the progression of proprioceptive integration abilities after ACL reconstruction surgery.

Interventions

  • Procedure ReproEVO intervention
    After the inclusion visit, each assessment will include an examination of standing balance in two support conditions: hard floor or soft floor and two conditions of vibration of the Achilles tendons or lumbar muscles, performed randomly over five trials for each condition. The subjects stand with their eyes covered by an opaque mask. Vibrators are positioned at both locations and vibrated randomly after a trial without recording to perceive the destabilizing effect induced by the vibration. The

Primary outcome measures

  • Assessment of progress in proprioceptive reweighting after knee ligament reconstruction [Time frame: Baseline, 3 months after surgery and 9 months after surgery]
Secondary outcome measures (4)
  • Assesment of the variation in weighting between before and after the operation [Time frame: Baseline and 3 months postoperatively]
  • Assess postural control [Time frame: Baseline, at 3 months postoperatively and at 9 months postoperatively]
  • Assess your Anterior Cruciate Ligament - Return to Sport and Injury (ACL-RSI) perception score [Time frame: Baseline, at 3 months postoperatively and at 9 months postoperatively]
  • Assess the subjective IKDC activity score [Time frame: Baseline, at 3 months postoperatively and at 9 months postoperatively]

Eligibility criteria

Inclusion criteria

  • Aged between 15 and 40;
  • Patients with ACL rupture scheduled for ACL reconstruction surgery;
  • Patients able to maintain a stable bipedal standing position without technical assistance and with their eyes closed;
  • Consent of the patient, parents, legal guardians, or guardians to the recording (for minor patients) of data for research and publication purposes.

Exclusion criteria

  • Recent osteoarticular pathology (i.e., less than three months) of the lower limbs, whether traumatic or not, other than ACL rupture;
  • Proven disabling neurological pathology;
  • Pain in the musculoskeletal system during exercise (excluding the operated knee);
  • Fatigue assessed using the Borg scale > 6;
  • Skin allergy to an adhesive product.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 3 centers
  • Brest University Hospital — Brest
  • Montpellier University Hospital — Montpellier
  • Dr. STER Clinic, Saint Clément de Rivière — Saint-Clément-de-Rivière

Identifiers

NCT: NCT07389850 · 29BRC25.0312

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗