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

Muscle Weakness Clinical Trial

— WEAKNESS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03200678
• Other study ID #: 2017-A00301-52
• Secondary ID: 2017RC01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: September 2023

Study information

• Verified date: April 2022
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury
• Muscle Weakness

Intervention

Other:
• isokinetic assessment
muscle torque assessement

Locations

Country	Name	City	State
France	Hôpital d'Instruction des Armées Clermont-Tonnerre	Brest

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle torque	Newton.meter (N.m)	Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2), measures at 9 months (V3)
Secondary	muscle work	Joule (J)	Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2) and measures at 9 months (V3)