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

Primary Purpose

Anterior Cruciate Ligament Injury, Muscle Weakness

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
isokinetic assessment
Sponsored by
Direction Centrale du Service de Santé des Armées
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anterior Cruciate Ligament Injury focused on measuring knee muscle, strength, fatigue, MRI, ACL

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpital d'Instruction des Armées Clermont-Tonnerre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ACLR Group

Control group

Arm Description

experimental: ACL surgery Intervention: isokinetic assessment

other Intervention: isokinetic assessment

Outcomes

Primary Outcome Measures

muscle torque
Newton.meter (N.m)

Secondary Outcome Measures

muscle work
Joule (J)

Full Information

First Posted
May 23, 2017
Last Updated
April 6, 2022
Sponsor
Direction Centrale du Service de Santé des Armées
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1. Study Identification

Unique Protocol Identification Number
NCT03200678
Brief Title
WEakness and Atrophy: isoKinetic With Surface Electromyography Assessment in ACL Surgery
Acronym
WEAKNESS
Official Title
Motor Unit Recruitment Study With Fatigue Testing: 9 Months Following up After Anterior Cruciate Ligament Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Direction Centrale du Service de Santé des Armées

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury, Muscle Weakness
Keywords
knee muscle, strength, fatigue, MRI, ACL

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACLR Group
Arm Type
Experimental
Arm Description
experimental: ACL surgery Intervention: isokinetic assessment
Arm Title
Control group
Arm Type
Other
Arm Description
other Intervention: isokinetic assessment
Intervention Type
Other
Intervention Name(s)
isokinetic assessment
Intervention Description
muscle torque assessement
Primary Outcome Measure Information:
Title
muscle torque
Description
Newton.meter (N.m)
Time Frame
Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2), measures at 9 months (V3)
Secondary Outcome Measure Information:
Title
muscle work
Description
Joule (J)
Time Frame
Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2) and measures at 9 months (V3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Tardy
Organizational Affiliation
Direction Centrale du Service de Santé des Armées
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital d'Instruction des Armées Clermont-Tonnerre
City
Brest
ZIP/Postal Code
29240 Brest Cedex 9
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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