Distribution of Knee Isokinetic Angle-specific Moments and Ratios (MOMANGLE)

July 12, 2022 updated by: University Hospital, Toulouse

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Toulouse, France, 31000
        • Marc Antoine DEMARET

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy subjects

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 DAY

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marc-Antoine DEMARET, MD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2021

Primary Completion (Actual)

April 15, 2022

Study Completion (Actual)

April 15, 2022

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 13, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/21/0251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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