Knee Functionality Recovery Indicators in Athletes Submitted to Ligamentoplasty of the Anterior Cruciate Ligament

Not Applicable

Recruiting

• Conditions: Ligament Rupture; Ligament Injury; Ligament Disorders
• Interventions: Diagnostic Test: Diagnostic test through functional tests and comparison of scales applied to participants in the pre-surgical and post-surgical period.

• Registration Number: NCT06050005
• Lead Sponsor: Universidade da Coruña

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.

Study Timeline

• Study First Submitted: 2023-06-13
• Study Start: 2023-06-15
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-17
• Last Update Submitted: 2023-09-17
• Study First Posted: 2023-09-22
• Last Update Posted: 2023-09-22
• Primary Completion: 2024-07-15
• Study Completion: 2024-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental - rehabilitation activity	Diagnostic test through functional tests and comparison of scales applied to participants in the pre-surgical and post-surgical period.	All participants will be included in this arm.

Primary Outcome Measures

Name	Time	Method
The International Knee Documentation Committee (IKDC) score	At 24 weeks after ACL reconstruction surgery.	The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)	At 24 weeks after ACL reconstruction surgery.	It is a specific 12-item questionnaire assessing the psychological impact (emotions, confidence in performance and evaluation of risk) of returning to sport after ACL reconstruction. Scores range from 0 to 100, and high scores were related to a positive psychological response
Lysholm Rating Scale	At 24 weeks after ACL reconstruction surgery.	This scale consists of eight items. It is scored on a scale of 0 to 100 with higher scores indicating fewer symptoms and higher levels of functioning.
Dynamic knee stability	At 24 weeks after ACL reconstruction surgery.	Single hop test. In this test, the aim is to jump as far as possible on a single leg, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg. The goal is to have a less than 10% difference in hop distance between the injured limb and uninjured limb.
Knee Injury and Osteoarthritis Outcome Score (KOOS)	At 24 weeks after ACL reconstruction surgery.	The dimensions from this scale are divided into 5 items (Symptoms, Pain, Activities of Daily Living, Sports and Leisure Activities and Quality of Life) on a positive orientation scale from 0 (extreme knee problems) to 100 (no knee problems).
Dynamic balance	At 24 weeks after ACL reconstruction surgery.	Change from baseline in a functional test - Y Balance Test
Lower Extremity Functional Scale (LEFS)	At 24 weeks after ACL reconstruction surgery.	This measurement instrument consists of 20 items, each of which is scored on a scale five points, from zero to four. The total LEFS score, with a minimum value of zero - low functional level - and maximum of 80 - high functional level, which can be exposed in percentage terms.

Trial Locations

Locations (1)

Clínica São João de Deus; 🇵🇹 Lisboa, Portugal