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

NCT06050005 | Unknown DMC

• 1 other identifier: Universidade da Coruña
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Ligament Injury; Ligament Rupture; Ligament Disorders

Keywords

Ligament injury; Preoperative; Postoperative; Functional tests

Outcome Measures

Primary Outcomes (26)

• Dynamic balance

  Change from baseline in a functional test - Y Balance Test - The test should be performed in the following order: Right Anterior, Left Anterior, Right Posteromedial, Left Posteromedial, Right Posterolateral. Left Posterolateral

  1 day before ACL reconstruction surgery

• Dynamic balance

  Change from baseline in a functional test - Y Balance Test

  At 6 weeks after ACL reconstruction surgery.

• Dynamic balance

  Change from baseline in a functional test - Y Balance Test

  At 12 weeks after ACL reconstruction surgery.

• Dynamic balance

  Change from baseline in a functional test - Y Balance Test

  At 24 weeks after ACL reconstruction surgery.

• Dynamic knee stability

  Hop test. In this test, the aim is to jump as far as possible with both legs, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg.

  At 12 weeks after ACL reconstruction surgery.

• Dynamic knee stability

  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.

  At 24 weeks after ACL reconstruction surgery.

• The International Knee Documentation Committee (IKDC) score

  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.

  1 day before ACL reconstruction surgery

• The International Knee Documentation Committee (IKDC) score

  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.

  At 6 weeks after ACL reconstruction surgery.

• The International Knee Documentation Committee (IKDC) score

  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.

  At 12 weeks after ACL reconstruction surgery.

• The International Knee Documentation Committee (IKDC) score

  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.

  At 24 weeks after ACL reconstruction surgery.

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  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).

  1 day before ACL reconstruction surgery

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  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).

  At 6 weeks after ACL reconstruction surgery.

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  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).

  At 12 weeks after ACL reconstruction surgery.

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  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).

  At 24 weeks after ACL reconstruction surgery.

• Lysholm Rating Scale

  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.

  1 day before ACL reconstruction surgery

• Lysholm Rating Scale

  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.

  At 6 weeks after ACL reconstruction surgery.

• Lysholm Rating Scale

  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.

  At 12 weeks after ACL reconstruction surgery.

• Lysholm Rating Scale

  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.

  At 24 weeks after ACL reconstruction surgery.

• Lower Extremity Functional Scale (LEFS)

  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.

  1 day before ACL reconstruction surgery

• Lower Extremity Functional Scale (LEFS)

  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.

  At 6 weeks after ACL reconstruction surgery.

• Lower Extremity Functional Scale (LEFS)

  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.

  At 12 weeks after ACL reconstruction surgery.

• Lower Extremity Functional Scale (LEFS)

  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.

  At 24 weeks after ACL reconstruction surgery.

• Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)

  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

  1 day before ACL reconstruction surgery

• Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)

  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

  At 6 weeks after ACL reconstruction surgery.

• Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)

  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

  At 12 weeks after ACL reconstruction surgery.

• Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)

  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

  At 24 weeks after ACL reconstruction surgery.

Study Arms (1)

Experimental - rehabilitation activity

EXPERIMENTAL

All participants will be included in this arm.

Diagnostic Test: Diagnostic test through functional tests and comparison of scales applied to participants in the pre-surgical and post-surgical period.

Interventions

Diagnostic test through functional tests and comparison of scales applied to participants in the pre-surgical and post-surgical period. DIAGNOSTIC_TEST

The protocol is based on the ligamentization stages, since the bibliography relates the ligamentization process with rehabilitation. These stages are necrosis, revascularization, cellular priorities and collagen formation, and different care is required for each stage. Taking these aspects into account, the authors developed recommendations to establish a protocol divided by the evaluation phases of the present work. Users should only move on to the next phase if they achieve the expected results, or that makes the total duration of each protocol vary from user to user. tests and scales will be evaluated before surgery, after 6 weeks of surgery and at the end of treatment.

Experimental - rehabilitation activity

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade da Coruña: lead

Study Sites (1)

Clínica São João de Deus

Lisbon, 1700-048, Portugal

RECRUITING

Study Officials

• Daniel López López, PhD

  Universidade da Coruña

  STUDY DIRECTOR

Central Study Contacts

Sérgio Loureiro Nuno, MSc

CONTACT

00351911713133; sergio.nuno@udc.es

Daniel López López, PhD

CONTACT

daniel.lopez.lopez@udc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc in Physical Therapy and Movement Analysis and PhD student in Health Sciences

Model Details: Experimental: rehabilitation activity All participants will be included in this arm.

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: September 22, 2023
• Study Start: June 15, 2023
• Primary Completion: July 15, 2024
• Study Completion: September 15, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)