Musculoskeletal DiseasesMOMANGLENCT05041400
Distribution of Knee Isokinetic Angle-specific Moments and Ratios
A study testing Evaluation of the strength of knee flexors and extensors in people with Musculoskeletal Diseases, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The quantification of the strength-producing capacity of the knee joint muscles by isokinetic measurement is one of the most widely used tools for monitoring and deciding whether to return to sport after ACL reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Evaluation of the strength of knee flexors and extensors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2021to 15 Apr 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects,
- Practicing a regular activity with a minimal activity of two trainings and one competition per week,
- Practicing this activity from at least 8 continuous weeks,
- Affiliated or benefiting from public health services.
Who cannot join
- Person presenting any of these conditions: professional player / athlete,
- patient with systemic pathology or treatment affecting the musculoskeletal system, patient with a history of traumatic pathology or any pathology requiring orthopaedic/surgical treatment of the knee and/or hip and/or spine,
- patient having a contraindication to an isokinetic test (disabling pain, progressive pathological process, unconsolidated fracture, unbalanced cardiovascular pathology), protected patient (adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision), Pregnant and/or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distribution of Knee Isokinetic Angle-specific Moments and Ratios: Searching for Normative Values in Healthy Subjects
The quantification of the strength-producing capacity of the knee joint muscles by isokinetic measurement is one of the most widely used tools for monitoring and deciding whether to return to sport after ACL reconstruction. However, the isokinetic evaluation performed in current practice does not exploit all the measures offered by this exploration technique, which can lead to errors in analysis and interpretation of the results and underestimate its ability to predict a return to sport under optimal conditions. Recently, more complete analysis models than those currently in use and integrating the moment-angle relationship have thus proposed the use of functional ratios sweeping the whole amplitude of the knee joint. Baumgart proposed an analysis of the variation of isokinetic force moments at each angle after ligamentoplasty. This approach seems to be the future of isokinetic performance analyses, but for the moment this has only been used in pathological populations and on small numbers of patients (less than 40). There are therefore no reference values in healthy subjects.
Read the detailed description
Rupture of the anterior cruciate ligament is a common sports trauma injury, frequently leading to a surgical intervention. However, despite the extensive scientific literature on the subject, return to sports at a lower level is common, sometimes to the point of giving up pivoting sports. Current rehabilitation strategies and the means used tend to limit their effectiveness, as do the batteries of tests for returning to sport .
One of the most widely used assessments for monitoring and decision-making on return to sport after ACL reconstruction is the quantification of the strength production capacity of the knee joint muscles by isokinetic measurement. However, the isokinetic evaluation carried out in current practice does not exploit all the measures offered by this exploration technique, which can lead to errors in the analysis and interpretation of the results . This discrepancy between the possibilities offered by this tool and its current exploitation may underestimate its capacity to predict a return to sport under optimal conditions .
In clinical practice, the analysis is reduced to the consideration of two indices: the peak torques of the extensor and flexor muscles of the knee, which are compared between the two legs (right and left sides), and the ratio between the torque peak of the flexor muscles and that of the extensor muscles, this ratio being considered as a control of joint balance. More comprehensive analysis models than those currently in use and integrating the moment-angle relationship have thus proposed the use of functional ratios sweeping the knee's joint range of motion. Baumgart has proposed an analysis of the variation of isokinetic force moments at each angle after ligamentoplasty . This approach seems to be the future of isokinetic performance analyses, but has so far only been used in pathological populations and on small numbers of patients (less than 40). There are therefore no reference values in healthy subjects. The search for reference values for the torque of the muscles of the knee over the entire angular range of motion represents an important line of research to improve the objective evaluation of the neuromuscular performance of the knee and the return to sport of patients, particularly following ACL reconstruction.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Evaluation of the strength of knee flexors and extensors
- Keywords
- knee isokinetic angle
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the strength of knee flexors and extensorsOther
Each participant will benefit from a clinical evaluation and an evaluation of the strength of knee flexors and extensors using an isokinetic dynamometer after a 10-minute warm up.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Other | Evaluation carried out on a BIODEX S4 Pro isokinetic dynamometer after a standardised 10-minute warm-up on this same dynamometer .
The measurement range will be from 0° (full extension) to 90° of flexion for each knee, providing 91 degrees of measurement. Receives: Other: Evaluation of the strength of knee flexors and extensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of knee isokinetic angle
The primary outcome will be composed of the following elements:(1)- a curve representing the distribution of the mean (and confidence interval) of the normative values of the knee flexors/extensors ratio at each angle on the tested amplitude, (2) a curve representing the distribution of the mean (and confidence interval) of the normative values of the right/left ratio at each angle on the tested amplitude,(3) a curve representing the distribution of the mean (and confidence interval) of the normative values of peak torque (normalized by subject mass) produced by the flexors and extensors at each angle over the amplitude tested, (4)- the distribution of the mean (and confidence interval) of the right/left differential on the value of the peak torque on the flexors and extensors and its angle of occurrence.
Measured: 1 DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start23 Sep 2021
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc-Antoine DEMARET, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041400
- Sponsor's protocol ID
- RC31/21/0251
- Acronym
- MOMANGLE
- Status last verified
- Jul 2022
- First submitted
- 2 Sep 2021
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ardern CL, Taylor NF, Feller JA, Webster KE. Fifty-five per cent return to competitive sport following anterior cruciate ligament reconstruction surgery: an updated systematic review and meta-analysis including aspects of physical functioning and contextual factors. Br J Sports Med. 2014 Nov;48(21):1543-52. doi: 10.1136/bjsports-2013-093398. Epub 2014 Aug 25.
PubMed 25157180Gokeler A, Welling W, Zaffagnini S, Seil R, Padua D. Development of a test battery to enhance safe return to sports after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):192-199. doi: 10.1007/s00167-016-4246-3. Epub 2016 Jul 16.
PubMed 27423208Baumgart C, Welling W, Hoppe MW, Freiwald J, Gokeler A. Angle-specific analysis of isokinetic quadriceps and hamstring torques and ratios in patients after ACL-reconstruction. BMC Sports Sci Med Rehabil. 2018 Dec 6;10:23. doi: 10.1186/s13102-018-0112-6. eCollection 2018.
PubMed 30534382
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of Knee Isokinetic Angle-specific Moments and Ratios: Searching for Normative Values in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05041400
- Acronym / sponsor ID
- MOMANGLE / RC31/21/0251
- Conditions
- Musculoskeletal Diseases
- Keywords
- knee isokinetic angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 13 Sep 2021 (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.
The quantification of the strength-producing capacity of the knee joint muscles by isokinetic measurement is one of the most widely used tools for monitoring and deciding whether to return to sport after ACL reconstruction. However, the isokinetic evaluation performed in current practice does not exploit all the measures offered by this exploration technique, which can lead to errors in analysis and interpretation of the results and underestimate its ability to predict a return to sport under optimal conditions. Recently, more complete analysis models than those currently in use and integrating the moment-angle relationship have thus proposed the use of functional ratios sweeping the whole amplitude of the knee joint. Baumgart proposed an analysis of the variation of isokinetic force moments at each angle after ligamentoplasty. This approach seems to be the future of isokinetic performance analyses, but for the moment this has only been used in pathological populations and on small numbers of patients (less than 40). There are therefore no reference values in healthy subjects.
Detailed description
Rupture of the anterior cruciate ligament is a common sports trauma injury, frequently leading to a surgical intervention. However, despite the extensive scientific literature on the subject, return to sports at a lower level is common, sometimes to the point of giving up pivoting sports. Current rehabilitation strategies and the means used tend to limit their effectiveness, as do the batteries of tests for returning to sport .
One of the most widely used assessments for monitoring and decision-making on return to sport after ACL reconstruction is the quantification of the strength production capacity of the knee joint muscles by isokinetic measurement. However, the isokinetic evaluation carried out in current practice does not exploit all the measures offered by this exploration technique, which can lead to errors in the analysis and interpretation of the results . This discrepancy between the possibilities offered by this tool and its current exploitation may underestimate its capacity to predict a return to sport under optimal conditions .
In clinical practice, the analysis is reduced to the consideration of two indices: the peak torques of the extensor and flexor muscles of the knee, which are compared between the two legs (right and left sides), and the ratio between the torque peak of the flexor muscles and that of the extensor muscles, this ratio being considered as a control of joint balance. More comprehensive analysis models than those currently in use and integrating the moment-angle relationship have thus proposed the use of functional ratios sweeping the knee's joint range of motion. Baumgart has proposed an analysis of the variation of isokinetic force moments at each angle after ligamentoplasty . This approach seems to be the future of isokinetic performance analyses, but has so far only been used in pathological populations and on small numbers of patients (less than 40). There are therefore no reference values in healthy subjects. The search for reference values for the torque of the muscles of the knee over the entire angular range of motion represents an important line of research to improve the objective evaluation of the neuromuscular performance of the knee and the return to sport of patients, particularly following ACL reconstruction.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Other | Other: Evaluation of the strength of knee flexors and extensorsEvaluation carried out on a BIODEX S4 Pro isokinetic dynamometer after a standardised 10-minute warm-up on this same dynamometer . The measurement range will be from 0° (full extension) to 90° of flexion for each knee, providing 91 degrees of measurement. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female subjects,
- Practicing a regular activity with a minimal activity of two trainings and one competition per week,
- Practicing this activity from at least 8 continuous weeks,
- Affiliated or benefiting from public health services.
Key exclusion criteria (3 listed)
- Person presenting any of these conditions: professional player / athlete,
- patient with systemic pathology or treatment affecting the musculoskeletal system, patient with a history of traumatic pathology or any pathology requiring orthopaedic/surgical treatment of the knee and/or hip and/or spine,
- patient having a contraindication to an isokinetic test (disabling pain, progressive pathological process, unconsolidated fracture, unbalanced cardiovascular pathology), protected patient (adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision), Pregnant and/or breastfeeding women.
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 |
|---|---|---|
| Evaluation of the strength of knee flexors and extensorsEach participant will benefit from a clinical evaluation and an evaluation of the strength of knee flexors and extensors using an isokinetic dynamometer after a 10-minute warm up. | Other | Healthy subjects |
Primary outcome
Distribution of knee isokinetic angle
Time frame: 1 DAY
The primary outcome will be composed of the following elements:(1)- a curve representing the distribution of the mean (and confidence interval) of the normative values of the knee flexors/extensors ratio at each angle on the tested amplitude, (2) a curve representing the distribution of the mean (and confidence interval) of the normative values of the right/left ratio at each angle on the tested amplitude,(3) a curve representing the distribution of the mean (and confidence interval) of the normative values of peak torque (normalized by subject mass) produced by the flexors and extensors at each angle over the amplitude tested, (4)- the distribution of the mean (and confidence interval) of the right/left differential on the value of the peak torque on the flexors and extensors and its angle of occurrence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Background: PubMed 25157180Ardern CL, Taylor NF, Feller JA, Webster KE. Fifty-five per cent return to competitive sport following anterior cruciate ligament reconstruction surgery: an updated systematic review and meta-analysis including aspects of physical functioning and contextual factors. Br J Sports Med. 2014 Nov;48(21):1543-52. doi: 10.1136/bjsports-2013-093398. Epub 2014 Aug 25.
- Background: PubMed 27423208Gokeler A, Welling W, Zaffagnini S, Seil R, Padua D. Development of a test battery to enhance safe return to sports after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):192-199. doi: 10.1007/s00167-016-4246-3. Epub 2016 Jul 16.
- Background: PubMed 30534382Baumgart C, Welling W, Hoppe MW, Freiwald J, Gokeler A. Angle-specific analysis of isokinetic quadriceps and hamstring torques and ratios in patients after ACL-reconstruction. BMC Sports Sci Med Rehabil. 2018 Dec 6;10:23. doi: 10.1186/s13102-018-0112-6. eCollection 2018.
- 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.
Marc-Antoine DEMARET, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of the strength of knee flexors and extensors in people with Musculoskeletal Diseases, run by University Hospital, Toulouse at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 13 Jul 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of knee isokinetic angle (time frame: 1 DAY). 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 NCT05041400, which also lists 3 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 13 Jul 2022.