WEakness and Atrophy: isoKinetic With Surface Electromyography Assessment in ACL Surgery (WEAKNESS)

April 6, 2022 updated by: Direction Centrale du Service de Santé des Armées

Motor Unit Recruitment Study With Fatigue Testing: 9 Months Following up After Anterior Cruciate Ligament Surgery.

An assessment of the effect of surgical anterior cruciate ligament (ACL) on thigh muscles is critical to the improvement of knee rehabilitation and preservation. However, if a large number of studies had rated surgical technics, giving high results level for ACL reconstruction (ACLR), muscle recovery is still conditioning functional success. Furthermore there is no consensus about criteria in return to sport.

The aim of this exploratory study is to quantify the mechanisms of neuromuscular adaptation of muscle thigh after ACL surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to assess the qualitative and quantitative variations of the strength, work and fatigue of the thigh muscles after ACL surgery. The reference is the preoperative assessment (V1), the variation is measured on V2 (measurements at 3 months) and V3 (measures at 9 months). Each patient is his own control. In addition, a control group of healthy subjects is used to determine level of significance of each parameter.

Study Type

Interventional

Enrollment (Actual)

80

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

  • France
      • Brest, France, 29240 Brest Cedex 9
        • Hôpital d'Instruction des Armées Clermont-Tonnerre

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 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

ACLR group :

  • men or woman
  • 18 to 45 years old
  • No injuries sequels on contralateral limb
  • No contraindication to magnetic resonance imaging

Control group :

  • men or woman
  • 18 to 45 years old
  • No limb injuries sequels
  • No contraindication to magnetic resonance imaging

Exclusion criteria:

  • age less than 18 years
  • limb injuries sequels
  • contraindication to magnetic resonance imaging

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: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ACLR Group
experimental: ACL surgery Intervention: isokinetic assessment
Other: isokinetic assessment
muscle torque assessement
OTHER: Control group
other Intervention: isokinetic assessment
Other: isokinetic assessment
muscle torque assessement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle torque
Time Frame: Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2), measures at 9 months (V3)
Newton.meter (N.m)
Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2), measures at 9 months (V3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle work
Time Frame: Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2) and measures at 9 months (V3)
Joule (J)
Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2) and measures at 9 months (V3)

Collaborators and Investigators

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

Sponsor

Direction Centrale du Service de Santé des Armées

Investigators

  • Principal Investigator: Dominique Tardy, Direction Centrale du Service de Santé des Armées

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)

May 7, 2018

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

September 1, 2023

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (ACTUAL)

June 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A00301-52
  • 2017RC01 (OTHER: DCSSA)

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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