Anterior Cruciate Ligament InjuriesACLRNCT05814445
Muscle Strengthening and Return-to-exercise Criteria After Anterior Cruciate Ligament Reconstruction (ACLR)
A study testing Neuromuscular exercise program and Institutional exercise program in people with Anterior Cruciate Ligament Injuries, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
Trial summary
Anterior cruciate ligament injury is very common in recreational and elite athletes. It is considered the second most frequent pathology seeing in Sports Medicine Services. After the injury and ACLR, there is a marked decrease in the strength of the knee extensors/flexors muscles. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Neuromuscular exercise program and Institutional exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteMexico
- Study dates
- 20 Aug 2021to 20 Mar 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of sports practice immediately prior to the injury
- Post-operated unilaterally for ACL with the hamstring autograft technique (semitendinosus-gracilis tendons),
- Full ranges of motion and no edema
- Body mass index < 30.0 kg/mˆ2
Who cannot join
- Multi-ligament knee injuries,
- More than 12 months from the injury to surgery
- More than 8 months after surgery
- Uncompensated metabolic diseases
- Acute illnesses/infections under treatment
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
National Institute of Rehabilitation
Mexico City, 14389
Andrea P Perez, MSc, 525559991000 ext. 15302, apegueros@inr.gob.mx
Rebeca S Romero, MSc, 525559991000 ext. 15224, rsalas@inr.gob.mx
About this study
Official title: Comparison of Two Muscle Strengthening Programs on the Return-to-exercise Criteria in Patients With Anterior Cruciate Ligament Reconstruction
Anterior cruciate ligament injury is very common in recreational and elite athletes. It is considered the second most frequent pathology seeing in Sports Medicine Services. After the injury and ACLR, there is a marked decrease in the strength of the knee extensors/flexors muscles. Strength exercise programs are aimed at recovering strength and functionality, however, a low percentage of patients manage to achieve the optimal return-to-exercise criteria. Therefore, it is relevant to design and evaluate exercise programs that allow early recovery of muscle strength and knee functionality. The main purpose of this study is to investigate a neuromuscular exercise program compared with a standard institutional program in the recovery of the strength and functionality of the knee extensor/flexor muscles after ACLR.
Read the detailed description
Study design: this is a 22-week, randomized trial. 62 participants will be recruited from the medical services of the National Institute of Rehabilitation (NIR).
Participants: adults between 20-40 years old, with a body mass index <30.0 kg/mˆ2, history of sports practice immediately prior to the injury, post-operated unilaterally for ACL with the hamstring autograft technique (semitendinosus-gracilis tendons), with full ranges of motion and no edema will be recruited. Participants with multi-ligament knee injuries, with more than 12 months from the injury to surgery or more than 8 months after surgery, with uncompensated metabolic diseases or acute illnesses/infections under treatment will not be recruited.
Intervention: participants will be randomized to 1) neuromuscular or 2) institutional exercise program with computer-generated random numbers. Both programs consist of isotonic open and closed kinetic chain exercises for the hip and knee. The neuromuscular program also includes exercises to improve vastus medialis and lateralis strength, hamstrings, hip flexors and extensors, proprioception, and core stability. On the other hand, the institutional program includes concentric and eccentric knee exercises. Both programs will be performed 3 days/week, 3 sets, 18-22 repetitions for each exercise; the intensity will initiate at 65-75% (1RM), and it will be increased to 75-85%; the workload will be increased 5-10% from the fifth week according to perceived exertion. The exercises will be done with both legs; however, the injured leg will be exercised complementary. The last 6 weeks of the programs correspond to functional exercises according the sport. Every training session will consist of 15 minutes of warm-up, 40-60 minutes of resistance training, and 15 minutes of cool-down; all training sessions will take place in the NIR Sports Medicine therapeutic gym.
The knee flexors/extensors muscle strength will be determined by isokinetic dynamometry (at 60°/s). The knee function will be evaluated by hop tests and agility T-test. The patient's perception of daily functional activities after ACL reconstruction will be assessed by the Lysholm knee score.
For each participant, the study length will be 22 weeks with 66 exercise sessions. The beginning of the study corresponds to session 1 of exercise. Initial evaluation will be performed 5 days prior to the start of the intervention, while final evaluations will be conducted at the end of 22 weeks of follow-up (2 days after the last day of the intervention). Data will be recorded by study investigators.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Neuromuscular exercise program, Institutional exercise program
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular exercise programOther
Participants will complete a neuromuscular program during 22 weeks. The program consist of isotonic open and closed kinetic chain exercises for the hip and knee, and training to improve hip and knee muscles strength, proprioception, and core stability.
Institutional exercise programOther
Participants will complete an institutional exercise program during 22 weeks. The program consist of isotonic open and closed kinetic chain exercises for the hip and knee, and concentric and eccentric knee exercises.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular exercise program | Experimental | Participants on a neuromuscular exercise program Receives: Other: Neuromuscular exercise program |
| Institutional exercise program | Active comparator | Participants on an institutional exercise program Receives: Other: Institutional exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee flexors muscle strength asymmetry
The asymmetry will be calculated as the percentage of the peak knee flexor torque in the involved limb over the peak knee flexor torque in the uninvolved limb, multiplied by 100.
Asymmetry % = (peak flexor torque involved limb/ peak flexor torque uninvolved limb) *100
Measured: 22 weeks
Knee extensors muscle strength asymmetry
The asymmetry will be calculated as the percentage of the peak knee extensor torque in the involved limb over the peak knee extensor torque in the uninvolved limb, multiplied by 100.
Asymmetry % = (peak extensor torque involved limb/peak extensor torque uninvolved limb)*100
Measured: 22 weeks
Hop distance asymmetry
The asymmetry will be calculated as the percentage of the hop distance (one leg hop, triple hop, or cross-over hop) in the involved limb over the hop distance in the uninvolved limb, multiplied by 100.
Asymmetry % = (hop distance involved limb/hop distance uninvolved limb)*100
Measured: 22 weeks
Agility T-test time
The time will be determined with data obtained from T-test; the fastest time will be recorded.
Measured: 22 weeks
Secondary outcomes (2)
Leg muscle quality index (MQIleg)
The muscle quality index from legs will be calculated with data obtained by isokinetic dynamometry, and lean mass obtained by bioimpedance analysis .
MQIleg = peak torque (Nm) / leg lean mass (kg)
Measured: Baseline and 22 weeks
Lysholm knee score
The score consists of eighth questions rated to produce an overall score on a point scale of 0 to 100. An assignment is given as excellent for 95 to 100 points, good for 84 to 94 points, fair for 66 to 83 points, and poor for less than 65 points.
Measured: Baseline and 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start20 Aug 2021
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Rehabilitacion
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ariadna del Villar Morales, Instituto Nacional de Rehabilitacion
- Investigators
- Ariadna d Morales, MD, Principal investigator, National Institute of Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814445
- Sponsor's protocol ID
- 27/21
- Acronym
- ACLR
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
LaBella CR, Hennrikus W, Hewett TE; Council on Sports Medicine and Fitness, and Section on Orthopaedics. Anterior cruciate ligament injuries: diagnosis, treatment, and prevention. Pediatrics. 2014 May;133(5):e1437-50. doi: 10.1542/peds.2014-0623.
PubMed 24777218van Melick N, van Cingel RE, Brooijmans F, Neeter C, van Tienen T, Hullegie W, Nijhuis-van der Sanden MW. Evidence-based clinical practice update: practice guidelines for anterior cruciate ligament rehabilitation based on a systematic review and multidisciplinary consensus. Br J Sports Med. 2016 Dec;50(24):1506-1515. doi: 10.1136/bjsports-2015-095898. Epub 2016 Aug 18.
PubMed 27539507Thomas AC, Villwock M, Wojtys EM, Palmieri-Smith RM. Lower extremity muscle strength after anterior cruciate ligament injury and reconstruction. J Athl Train. 2013 Sep-Oct;48(5):610-20. doi: 10.4085/1062-6050-48.3.23. Epub 2013 Apr 18.
PubMed 24067150Buckthorpe M, La Rosa G, Villa FD. RESTORING KNEE EXTENSOR STRENGTH AFTER ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: A CLINICAL COMMENTARY. Int J Sports Phys Ther. 2019 Feb;14(1):159-172.
PubMed 30746302Palmieri-Smith RM, Lepley LK. Quadriceps Strength Asymmetry After Anterior Cruciate Ligament Reconstruction Alters Knee Joint Biomechanics and Functional Performance at Time of Return to Activity. Am J Sports Med. 2015 Jul;43(7):1662-9. doi: 10.1177/0363546515578252. Epub 2015 Apr 16.
PubMed 25883169Della Villa S, Boldrini L, Ricci M, Danelon F, Snyder-Mackler L, Nanni G, Roi GS. Clinical Outcomes and Return-to-Sports Participation of 50 Soccer Players After Anterior Cruciate Ligament Reconstruction Through a Sport-Specific Rehabilitation Protocol. Sports Health. 2012 Jan;4(1):17-24. doi: 10.1177/1941738111417564.
PubMed 23016064Souissi S, Wong del P, Dellal A, Croisier JL, Ellouze Z, Chamari K. Improving Functional Performance and Muscle Power 4-to-6 Months After Anterior Cruciate Ligament Reconstruction. J Sports Sci Med. 2011 Dec 1;10(4):655-64. eCollection 2011.
PubMed 24149555Cavanaugh JT, Powers M. ACL Rehabilitation Progression: Where Are We Now? Curr Rev Musculoskelet Med. 2017 Sep;10(3):289-296. doi: 10.1007/s12178-017-9426-3.
PubMed 28791612Myer GD, Brent JL, Ford KR, Hewett TE. Real-time assessment and neuromuscular training feedback techniques to prevent ACL injury in female athletes. Strength Cond J. 2011 Jun 1;33(3):21-35. doi: 10.1519/SSC.0b013e318213afa8.
PubMed 21643474Reid A, Birmingham TB, Stratford PW, Alcock GK, Giffin JR. Hop testing provides a reliable and valid outcome measure during rehabilitation after anterior cruciate ligament reconstruction. Phys Ther. 2007 Mar;87(3):337-49. doi: 10.2522/ptj.20060143. Epub 2007 Feb 20.
PubMed 17311886Noyes FR, Barber SD, Mangine RE. Abnormal lower limb symmetry determined by function hop tests after anterior cruciate ligament rupture. Am J Sports Med. 1991 Sep-Oct;19(5):513-8. doi: 10.1177/036354659101900518.
PubMed 1962720Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S208-28. doi: 10.1002/acr.20632. No abstract available.
PubMed 22588746Abrams GD, Harris JD, Gupta AK, McCormick FM, Bush-Joseph CA, Verma NN, Cole BJ, Bach BR Jr. Functional Performance Testing After Anterior Cruciate Ligament Reconstruction: A Systematic Review. Orthop J Sports Med. 2014 Jan 21;2(1):2325967113518305. doi: 10.1177/2325967113518305. eCollection 2014 Jan.
PubMed 26535266Kyritsis P, Bahr R, Landreau P, Miladi R, Witvrouw E. Likelihood of ACL graft rupture: not meeting six clinical discharge criteria before return to sport is associated with a four times greater risk of rupture. Br J Sports Med. 2016 Aug;50(15):946-51. doi: 10.1136/bjsports-2015-095908. Epub 2016 May 23.
PubMed 27215935Schmitt LC, Paterno MV, Hewett TE. The impact of quadriceps femoris strength asymmetry on functional performance at return to sport following anterior cruciate ligament reconstruction. J Orthop Sports Phys Ther. 2012 Sep;42(9):750-9. doi: 10.2519/jospt.2012.4194. Epub 2012 Jul 19.
PubMed 22813542
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Muscle Strengthening Programs on the Return-to-exercise Criteria in Patients With Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT05814445
- Acronym / sponsor ID
- ACLR / 27/21
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Instituto Nacional de RehabilitacionOther government
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Mar 2024 (estimated)
- First posted
- 14 Apr 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 injury is very common in recreational and elite athletes. It is considered the second most frequent pathology seeing in Sports Medicine Services. After the injury and ACLR, there is a marked decrease in the strength of the knee extensors/flexors muscles. Strength exercise programs are aimed at recovering strength and functionality, however, a low percentage of patients manage to achieve the optimal return-to-exercise criteria. Therefore, it is relevant to design and evaluate exercise programs that allow early recovery of muscle strength and knee functionality. The main purpose of this study is to investigate a neuromuscular exercise program compared with a standard institutional program in the recovery of the strength and functionality of the knee extensor/flexor muscles after ACLR.
Detailed description
Study design: this is a 22-week, randomized trial. 62 participants will be recruited from the medical services of the National Institute of Rehabilitation (NIR).
Participants: adults between 20-40 years old, with a body mass index <30.0 kg/mˆ2, history of sports practice immediately prior to the injury, post-operated unilaterally for ACL with the hamstring autograft technique (semitendinosus-gracilis tendons), with full ranges of motion and no edema will be recruited. Participants with multi-ligament knee injuries, with more than 12 months from the injury to surgery or more than 8 months after surgery, with uncompensated metabolic diseases or acute illnesses/infections under treatment will not be recruited.
Intervention: participants will be randomized to 1) neuromuscular or 2) institutional exercise program with computer-generated random numbers. Both programs consist of isotonic open and closed kinetic chain exercises for the hip and knee. The neuromuscular program also includes exercises to improve vastus medialis and lateralis strength, hamstrings, hip flexors and extensors, proprioception, and core stability. On the other hand, the institutional program includes concentric and eccentric knee exercises. Both programs will be performed 3 days/week, 3 sets, 18-22 repetitions for each exercise; the intensity will initiate at 65-75% (1RM), and it will be increased to 75-85%; the workload will be increased 5-10% from the fifth week according to perceived exertion. The exercises will be done with both legs; however, the injured leg will be exercised complementary. The last 6 weeks of the programs correspond to functional exercises according the sport. Every training session will consist of 15 minutes of warm-up, 40-60 minutes of resistance training, and 15 minutes of cool-down; all training sessions will take place in the NIR Sports Medicine therapeutic gym.
The knee flexors/extensors muscle strength will be determined by isokinetic dynamometry (at 60°/s). The knee function will be evaluated by hop tests and agility T-test. The patient's perception of daily functional activities after ACL reconstruction will be assessed by the Lysholm knee score.
For each participant, the study length will be 22 weeks with 66 exercise sessions. The beginning of the study corresponds to session 1 of exercise. Initial evaluation will be performed 5 days prior to the start of the intervention, while final evaluations will be conducted at the end of 22 weeks of follow-up (2 days after the last day of the intervention). Data will be recorded by study investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular exercise program | Experimental | Other: Neuromuscular exercise programParticipants on a neuromuscular exercise program |
| Institutional exercise program | Active comparator | Other: Institutional exercise programParticipants on an institutional exercise program |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- History of sports practice immediately prior to the injury
- Post-operated unilaterally for ACL with the hamstring autograft technique (semitendinosus-gracilis tendons),
- Full ranges of motion and no edema
- Body mass index < 30.0 kg/mˆ2
Key exclusion criteria (5 listed)
- Multi-ligament knee injuries,
- More than 12 months from the injury to surgery
- More than 8 months after surgery
- Uncompensated metabolic diseases
- Acute illnesses/infections under treatment
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 |
|---|---|---|
| Neuromuscular exercise programParticipants will complete a neuromuscular program during 22 weeks. The program consist of isotonic open and closed kinetic chain exercises for the hip and knee, and training to improve hip and knee muscles strength, proprioception, and core stability. | Other | Neuromuscular exercise program |
| Institutional exercise programParticipants will complete an institutional exercise program during 22 weeks. The program consist of isotonic open and closed kinetic chain exercises for the hip and knee, and concentric and eccentric knee exercises. | Other | Institutional exercise program |
Primary outcome
Knee flexors muscle strength asymmetry
Time frame: 22 weeks
The asymmetry will be calculated as the percentage of the peak knee flexor torque in the involved limb over the peak knee flexor torque in the uninvolved limb, multiplied by 100. Asymmetry % = (peak flexor torque involved limb/ peak flexor torque uninvolved limb) *100
Knee extensors muscle strength asymmetry
Time frame: 22 weeks
The asymmetry will be calculated as the percentage of the peak knee extensor torque in the involved limb over the peak knee extensor torque in the uninvolved limb, multiplied by 100. Asymmetry % = (peak extensor torque involved limb/peak extensor torque uninvolved limb)*100
Hop distance asymmetry
Time frame: 22 weeks
The asymmetry will be calculated as the percentage of the hop distance (one leg hop, triple hop, or cross-over hop) in the involved limb over the hop distance in the uninvolved limb, multiplied by 100. Asymmetry % = (hop distance involved limb/hop distance uninvolved limb)*100
Agility T-test time
Time frame: 22 weeks
The time will be determined with data obtained from T-test; the fastest time will be recorded.
2 secondary outcomes
Leg muscle quality index (MQIleg)
Time frame: Baseline and 22 weeks
Lysholm knee score
Time frame: Baseline and 22 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Background: PubMed 24777218LaBella CR, Hennrikus W, Hewett TE; Council on Sports Medicine and Fitness, and Section on Orthopaedics. Anterior cruciate ligament injuries: diagnosis, treatment, and prevention. Pediatrics. 2014 May;133(5):e1437-50. doi: 10.1542/peds.2014-0623.
- Background: PubMed 27539507van Melick N, van Cingel RE, Brooijmans F, Neeter C, van Tienen T, Hullegie W, Nijhuis-van der Sanden MW. Evidence-based clinical practice update: practice guidelines for anterior cruciate ligament rehabilitation based on a systematic review and multidisciplinary consensus. Br J Sports Med. 2016 Dec;50(24):1506-1515. doi: 10.1136/bjsports-2015-095898. Epub 2016 Aug 18.
- Background: PubMed 24067150Thomas AC, Villwock M, Wojtys EM, Palmieri-Smith RM. Lower extremity muscle strength after anterior cruciate ligament injury and reconstruction. J Athl Train. 2013 Sep-Oct;48(5):610-20. doi: 10.4085/1062-6050-48.3.23. Epub 2013 Apr 18.
- Background: PubMed 30746302Buckthorpe M, La Rosa G, Villa FD. RESTORING KNEE EXTENSOR STRENGTH AFTER ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: A CLINICAL COMMENTARY. Int J Sports Phys Ther. 2019 Feb;14(1):159-172.
- Background: PubMed 25883169Palmieri-Smith RM, Lepley LK. Quadriceps Strength Asymmetry After Anterior Cruciate Ligament Reconstruction Alters Knee Joint Biomechanics and Functional Performance at Time of Return to Activity. Am J Sports Med. 2015 Jul;43(7):1662-9. doi: 10.1177/0363546515578252. Epub 2015 Apr 16.
- Background: PubMed 23016064Della Villa S, Boldrini L, Ricci M, Danelon F, Snyder-Mackler L, Nanni G, Roi GS. Clinical Outcomes and Return-to-Sports Participation of 50 Soccer Players After Anterior Cruciate Ligament Reconstruction Through a Sport-Specific Rehabilitation Protocol. Sports Health. 2012 Jan;4(1):17-24. doi: 10.1177/1941738111417564.
- Background: PubMed 24149555Souissi S, Wong del P, Dellal A, Croisier JL, Ellouze Z, Chamari K. Improving Functional Performance and Muscle Power 4-to-6 Months After Anterior Cruciate Ligament Reconstruction. J Sports Sci Med. 2011 Dec 1;10(4):655-64. eCollection 2011.
- Background: PubMed 28791612Cavanaugh JT, Powers M. ACL Rehabilitation Progression: Where Are We Now? Curr Rev Musculoskelet Med. 2017 Sep;10(3):289-296. doi: 10.1007/s12178-017-9426-3.
- Background: PubMed 21643474Myer GD, Brent JL, Ford KR, Hewett TE. Real-time assessment and neuromuscular training feedback techniques to prevent ACL injury in female athletes. Strength Cond J. 2011 Jun 1;33(3):21-35. doi: 10.1519/SSC.0b013e318213afa8.
- Background: PubMed 17311886Reid A, Birmingham TB, Stratford PW, Alcock GK, Giffin JR. Hop testing provides a reliable and valid outcome measure during rehabilitation after anterior cruciate ligament reconstruction. Phys Ther. 2007 Mar;87(3):337-49. doi: 10.2522/ptj.20060143. Epub 2007 Feb 20.
- Background: PubMed 1962720Noyes FR, Barber SD, Mangine RE. Abnormal lower limb symmetry determined by function hop tests after anterior cruciate ligament rupture. Am J Sports Med. 1991 Sep-Oct;19(5):513-8. doi: 10.1177/036354659101900518.
- Background: PubMed 22588746Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S208-28. doi: 10.1002/acr.20632. No abstract available.
- Activate adult. World rugby injury prevention exercise programme.Link provided by the sponsor.
- 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.
Ariadna d Morales, MD principal investigator
National Institute of Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular exercise program and Institutional exercise program in people with Anterior Cruciate Ligament Injuries, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
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 4 inclusion and 5 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 14 Apr 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 Mexico. 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 Andrea P Perez, MSc (525559991000 ext. 15302, apegueros@inr.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee flexors muscle strength asymmetry (time frame: 22 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05814445, which also lists 20 linked publications.
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 14 Apr 2023.