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

Primary Purpose

Ligament Injury, Ligament Rupture, Ligament Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Diagnostic test through functional tests and comparison of scales applied to participants in the pre-surgical and post-surgical period.
Sponsored by
Universidade da Coruña
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ligament Injury focused on measuring Ligament injury, Preoperative, Postoperative, Functional tests

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clínica São João de DeusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental - rehabilitation activity

Arm Description

All participants will be included in this arm.

Outcomes

Primary Outcome Measures

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
Dynamic balance
Change from baseline in a functional test - Y Balance Test
Dynamic balance
Change from baseline in a functional test - Y Balance Test
Dynamic balance
Change from baseline in a functional test - Y Balance Test
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
June 13, 2023
Last Updated
September 17, 2023
Sponsor
Universidade da Coruña
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1. Study Identification

Unique Protocol Identification Number
NCT06050005
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade da Coruña

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ligament Injury, Ligament Rupture, Ligament Disorders
Keywords
Ligament injury, Preoperative, Postoperative, Functional tests

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Experimental: rehabilitation activity All participants will be included in this arm.
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental - rehabilitation activity
Arm Type
Experimental
Arm Description
All participants will be included in this arm.
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic test through functional tests and comparison of scales applied to participants in the pre-surgical and post-surgical period.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dynamic balance
Description
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
Time Frame
1 day before ACL reconstruction surgery
Title
Dynamic balance
Description
Change from baseline in a functional test - Y Balance Test
Time Frame
At 6 weeks after ACL reconstruction surgery.
Title
Dynamic balance
Description
Change from baseline in a functional test - Y Balance Test
Time Frame
At 12 weeks after ACL reconstruction surgery.
Title
Dynamic balance
Description
Change from baseline in a functional test - Y Balance Test
Time Frame
At 24 weeks after ACL reconstruction surgery.
Title
Dynamic knee stability
Description
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.
Time Frame
At 12 weeks after ACL reconstruction surgery.
Title
Dynamic knee stability
Description
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.
Time Frame
At 24 weeks after ACL reconstruction surgery.
Title
The International Knee Documentation Committee (IKDC) score
Description
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.
Time Frame
1 day before ACL reconstruction surgery
Title
The International Knee Documentation Committee (IKDC) score
Description
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.
Time Frame
At 6 weeks after ACL reconstruction surgery.
Title
The International Knee Documentation Committee (IKDC) score
Description
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.
Time Frame
At 12 weeks after ACL reconstruction surgery.
Title
The International Knee Documentation Committee (IKDC) score
Description
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.
Time Frame
At 24 weeks after ACL reconstruction surgery.
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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).
Time Frame
1 day before ACL reconstruction surgery
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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).
Time Frame
At 6 weeks after ACL reconstruction surgery.
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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).
Time Frame
At 12 weeks after ACL reconstruction surgery.
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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).
Time Frame
At 24 weeks after ACL reconstruction surgery.
Title
Lysholm Rating Scale
Description
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.
Time Frame
1 day before ACL reconstruction surgery
Title
Lysholm Rating Scale
Description
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.
Time Frame
At 6 weeks after ACL reconstruction surgery.
Title
Lysholm Rating Scale
Description
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.
Time Frame
At 12 weeks after ACL reconstruction surgery.
Title
Lysholm Rating Scale
Description
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.
Time Frame
At 24 weeks after ACL reconstruction surgery.
Title
Lower Extremity Functional Scale (LEFS)
Description
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.
Time Frame
1 day before ACL reconstruction surgery
Title
Lower Extremity Functional Scale (LEFS)
Description
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.
Time Frame
At 6 weeks after ACL reconstruction surgery.
Title
Lower Extremity Functional Scale (LEFS)
Description
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.
Time Frame
At 12 weeks after ACL reconstruction surgery.
Title
Lower Extremity Functional Scale (LEFS)
Description
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.
Time Frame
At 24 weeks after ACL reconstruction surgery.
Title
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Description
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
Time Frame
1 day before ACL reconstruction surgery
Title
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Description
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
Time Frame
At 6 weeks after ACL reconstruction surgery.
Title
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Description
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
Time Frame
At 12 weeks after ACL reconstruction surgery.
Title
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Description
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
Time Frame
At 24 weeks after ACL reconstruction surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sérgio Loureiro Nuno, MSc
Phone
00351911713133
Email
sergio.nuno@udc.es
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel López López, PhD
Ext
3546
Email
daniel.lopez.lopez@udc.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel López López, PhD
Organizational Affiliation
Universidade da Coruña
Official's Role
Study Director
Facility Information:
Facility Name
Clínica São João de Deus
City
Lisboa
ZIP/Postal Code
1700-048
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sérgio Nuno
First Name & Middle Initial & Last Name & Degree
Daniel López
First Name & Middle Initial & Last Name & Degree
Carlos Romero

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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