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
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
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
NCT ID
NCT03200678
First Posted
May 23, 2017
Last Updated
April 6, 2022
Sponsor
Direction Centrale du Service de Santé des Armées
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
Learn more about this trial
WEakness and Atrophy: isoKinetic With Surface Electromyography Assessment in ACL Surgery
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