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

Primary Purpose

Musculoskeletal Diseases

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluation of the strength of knee flexors and extensors
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Musculoskeletal Diseases focused on measuring knee isokinetic angle

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Marc Antoine DEMARET

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Healthy subjects

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 2, 2021
Last Updated
July 12, 2022
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05041400
Brief Title
Distribution of Knee Isokinetic Angle-specific Moments and Ratios
Acronym
MOMANGLE
Official Title
Distribution of Knee Isokinetic Angle-specific Moments and Ratios: Searching for Normative Values in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 23, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

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

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases
Keywords
knee isokinetic angle

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Evaluation of the strength of knee flexors and extensors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Distribution of knee isokinetic angle
Description
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.
Time Frame
1 DAY

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc-Antoine DEMARET, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marc Antoine DEMARET
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25157180
Citation
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.
Results Reference
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PubMed Identifier
27423208
Citation
Gokeler 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.
Results Reference
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PubMed Identifier
30534382
Citation
Baumgart 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.
Results Reference
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Distribution of Knee Isokinetic Angle-specific Moments and Ratios

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