ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 39 of 85 for:    Recruiting, Not yet recruiting, Available Studies | "Anterior Cruciate Ligament"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03200678
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Direction Centrale du Service de Santé des Armées

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury Muscle Weakness Other: isokinetic assessment Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Motor Unit Recruitment Study With Fatigue Testing: 9 Months Following up After Anterior Cruciate Ligament Surgery.
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: ACLR Group
experimental: ACL surgery Intervention: isokinetic assessment
Other: isokinetic assessment
muscle torque assessement

Control group
other Intervention: isokinetic assessment
Other: isokinetic assessment
muscle torque assessement




Primary Outcome Measures :
  1. muscle torque [ Time Frame: Change is being assessed betwin preoperative assessment (V1), measurement at 3 months (V2), measures at 9 months (V3) ]
    Newton.meter (N.m)


Secondary Outcome Measures :
  1. muscle work [ Time Frame: Change is being assessed betwin preoperative assessment (V1), measurement at 3 months (V2) and measures at 9 months (V3) ]
    Joule (J)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200678


Contacts
Contact: Ronan Grimandi 298437303 ext +33 ronan.grimandi@intradef.gouv.fr

Locations
France
Hôpital d'Instruction des Armées Clermont-Tonnerre Recruiting
Brest, France, 29240 Brest Cedex 9
Contact: Ronan Grimandi, PT MS    +33 0298437303    ronan.grimandi@intradef.gouv.fr   
Principal Investigator: Ronan Grimandi, PT MS         
Sub-Investigator: Marie-Agnès Giroux-Metges, MD PhD         
Sub-Investigator: Dominique Tardy, MD         
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
Investigators
Principal Investigator: Dominique Tardy Direction Centrale du Service de Santé des Armées

Responsible Party: Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT03200678     History of Changes
Other Study ID Numbers: 2017-A00301-52
2017RC01 ( Other Identifier: DCSSA )
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Direction Centrale du Service de Santé des Armées:
knee muscle
strength
fatigue
MRI
ACL

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Knee Injuries
Leg Injuries
Wounds and Injuries