Clinical trial NCT06050005: Knee Functionality Recovery Indicators in Athletes Submitted to Ligamentoplasty of the Anterior Cruciate Ligament
Official title: Knee Functionality Recovery Indicators in Athletes Submitted to Ligamentoplasty of the Anterior Cruciate Ligament
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ligament Injury
Ligament Rupture
Ligament Disorders
Keywords: Ligament injury
Preoperative
Postoperative
Functional tests
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Experimental: rehabilitation activity All participants will be included in this arm.
Primary purpose: TREATMENT

Brief summary: Anterior cruciate ligament (ACL) injuries are recurrent, especially in sports. There is still no consensus on the characterization of functional indicators in this clinical condition, as well as their correlation with measuring instruments and clinical functional tests. It is intended to study the changes in functionality of users undergoing this surgery, aiming with functional assessment scales at different times of recovery. This will allow deciding on more adapted recovery strategies, which can meet the musculoskeletal requirements of the user.

Detailed description: It is proposed to carry by carrying out quasi-experimental, quantitative and analytical studies. The sample will consist of athletes who have started recovering from ACL surgery and who meet the previously established inclusion and exclusion criteria.

The study will use and compare functional tests (Star Excursion Balance Test, Lateral Step Down Test and Weight-Bearing Lunge Test) with measurement instruments: Knee and Osteoarthritis Outcome Score (KOOS), Lyshom Knee Scoring Scale, Lower Extremity Functional Score (LEFS), Return to Sport After Injury Scale (ACL-RSI) and IKDC Subjective Knee Evaluation Form.

The intervention will be performed on individual athletes who have had anterior cruciate ligament injury for the first time or recurrence of this ligament in the same knee or injury in the contralateral knee.

Eligibility criteria: Inclusion Criteria:

* Start of physiotherapy in the preoperative context and continuation of recovery up to 2 weeks after surgery; age equal to or greater than 18 years; With or without meniscal injury; Be able to correctly fill in the assessment instruments and complete the Informed Consent Form;

Exclusion Criteria:

* Concomitant bilateral injury/history of surgery or contralateral dysfunction; meniscal suture; cartilaginous injury; injury to the internal lateral ligament, external lateral ligament and posterior cruciate ligament; concomitant intra and extra-articular plastic surgery; individuals with recent heart disease, intermittent claudication, neuropathies and cognitive alterations.

Primary outcomes:
measure: Dynamic balance
timeFrame: 1 day before ACL reconstruction surgery
measure: Dynamic balance
timeFrame: At 6 weeks after ACL reconstruction surgery.
measure: Dynamic balance
timeFrame: At 12 weeks after ACL reconstruction surgery.
measure: Dynamic balance
timeFrame: At 24 weeks after ACL reconstruction surgery.
measure: Dynamic knee stability
timeFrame: At 12 weeks after ACL reconstruction surgery.
measure: Dynamic knee stability
timeFrame: At 24 weeks after ACL reconstruction surgery.
measure: The International Knee Documentation Committee (IKDC) score
timeFrame: 1 day before ACL reconstruction surgery
measure: The International Knee Documentation Committee (IKDC) score
timeFrame: At 6 weeks after ACL reconstruction surgery.
measure: The International Knee Documentation Committee (IKDC) score
timeFrame: At 12 weeks after ACL reconstruction surgery.
measure: The International Knee Documentation Committee (IKDC) score
timeFrame: At 24 weeks after ACL reconstruction surgery.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 1 day before ACL reconstruction surgery
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At 6 weeks after ACL reconstruction surgery.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At 12 weeks after ACL reconstruction surgery.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At 24 weeks after ACL reconstruction surgery.
measure: Lysholm Rating Scale
timeFrame: 1 day before ACL reconstruction surgery
measure: Lysholm Rating Scale
timeFrame: At 6 weeks after ACL reconstruction surgery.
measure: Lysholm Rating Scale
timeFrame: At 12 weeks after ACL reconstruction surgery.
measure: Lysholm Rating Scale
timeFrame: At 24 weeks after ACL reconstruction surgery.
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: 1 day before ACL reconstruction surgery
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: At 6 weeks after ACL reconstruction surgery.
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: At 12 weeks after ACL reconstruction surgery.
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: At 24 weeks after ACL reconstruction surgery.
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: 1 day before ACL reconstruction surgery
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: At 6 weeks after ACL reconstruction surgery.
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: At 12 weeks after ACL reconstruction surgery.
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: At 24 weeks after ACL reconstruction surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Clínica São João de Deus
Study officials:
affiliation: Universidade da Coruña
name: Daniel López López, PhD
role: STUDY_DIRECTOR
References: