Ligament InjuryNCT06050005
Knee Functionality Recovery Indicators in Athletes Submitted to Ligamentoplasty of the Anterior Cruciate Ligament
A study testing Diagnostic test through functional tests and comparison of scales applied to participants in the pre-surgical and post-surgical period. in people with Ligament Injury and Ligament Rupture, run by Universidade da Coruña at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ligament Injury, Ligament Rupture, Ligament Disorders
- What is being tested?
- Diagnostic test through functional tests and comparison of scales applied to participants in the pre-surgical and post-surgical period.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Jun 2023to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Daniel López López, PhD contact
Portugal1 site, 1 recruiting
- Recruiting
Clínica São João de Deus
Lisbon, 1700-048
Sérgio Nuno
Daniel López
About this study
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.
Read the 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.
- Conditions
- Ligament Injury, Ligament Rupture, Ligament Disorders
- Being tested
- Diagnostic test through functional tests and comparison of scales applied to participants in the pre-surgical and post-surgical period.
- Keywords
- Ligament injury, Preoperative, Postoperative, Functional tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - rehabilitation activity | Experimental | All participants will be included in this arm. Receives: Diagnostic Test: Diagnostic test through functional tests and comparison of scales applied to participants in the pre-surgical and post-surgical period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day before ACL reconstruction surgery
Dynamic balance
Change from baseline in a functional test - Y Balance Test
Measured: At 6 weeks after ACL reconstruction surgery.
Dynamic balance
Change from baseline in a functional test - Y Balance Test
Measured: At 12 weeks after ACL reconstruction surgery.
Dynamic balance
Change from baseline in a functional test - Y Balance Test
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 24 weeks after ACL reconstruction surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start15 Jun 2023
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ligament InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental: rehabilitation activity All participants will be included in this arm.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sérgio Miguel Loureiro Nuno, Universidade da Coruña
- Investigators
- Daniel López López, PhD, Study director, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050005
- Sponsor's protocol ID
- Universidade da Coruña
- Status last verified
- Sep 2023
- First submitted
- 13 Jun 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Functionality Recovery Indicators in Athletes Submitted to Ligamentoplasty of the Anterior Cruciate Ligament
- ClinicalTrials.gov ID
- NCT06050005
- Acronym / sponsor ID
- Universidade da Coruña
- Conditions
- Ligament Injury, Ligament Rupture, Ligament Disorders
- Keywords
- Ligament injury, Preoperative, Postoperative, Functional tests
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental: rehabilitation activity All participants will be included in this arm.
| Arm | Type | Receives |
|---|---|---|
| Experimental - rehabilitation activity | Experimental | Diagnostic Test: 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic test through functional tests and comparison of scales applied to participants in the pre-surgical and post-surgical period.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. | Diagnostic test | Experimental - rehabilitation activity |
Primary outcome
Dynamic balance
Time frame: 1 day before ACL reconstruction surgery
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
Time frame: At 6 weeks after ACL reconstruction surgery.
Change from baseline in a functional test - Y Balance Test
Dynamic balance
Time frame: At 12 weeks after ACL reconstruction surgery.
Change from baseline in a functional test - Y Balance Test
Dynamic balance
Time frame: At 24 weeks after ACL reconstruction surgery.
Change from baseline in a functional test - Y Balance Test
Dynamic knee stability
Time frame: At 12 weeks after ACL reconstruction surgery.
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
Time frame: 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.
The International Knee Documentation Committee (IKDC) score
Time frame: 1 day before 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.
The International Knee Documentation Committee (IKDC) score
Time frame: At 6 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.
The International Knee Documentation Committee (IKDC) score
Time frame: At 12 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.
The International Knee Documentation Committee (IKDC) score
Time frame: 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.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 1 day before 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).
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At 6 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).
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At 12 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).
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 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).
Lysholm Rating Scale
Time frame: 1 day before 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.
Lysholm Rating Scale
Time frame: At 6 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.
Lysholm Rating Scale
Time frame: At 12 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.
Lysholm Rating Scale
Time frame: 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.
Lower Extremity Functional Scale (LEFS)
Time frame: 1 day before 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.
Lower Extremity Functional Scale (LEFS)
Time frame: At 6 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.
Lower Extremity Functional Scale (LEFS)
Time frame: At 12 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.
Lower Extremity Functional Scale (LEFS)
Time frame: 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.
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: 1 day before 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
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: At 6 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
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: At 12 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
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel López López, PhD contact
Daniel López López, PhD study director
Universidade da Coruña
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic test through functional tests and comparison of scales applied to participants in the pre-surgical and post-surgical period. in people with Ligament Injury and Ligament Rupture, run by Universidade da Coruña at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sérgio Loureiro Nuno, MSc (00351911713133, sergio.nuno@udc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic balance (time frame: 1 day before ACL reconstruction surgery). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.