NCT06783062

Brief Summary

The primary objective of the study is to evaluate the impact of ACL injury and ACL reconstruction on voluntary activation during maximal voluntary contraction (measured by neurophysiological parameters) according to the contraction mode. The goal is to provide elements of knowledge to clinicians about the mechanisms of the activation failure depending on contraction mode, but also the resulting adapted clinical recommendations for conducting rehabilitation, and particularly for the use of different contraction modes. The main hypothesis is that activation failure is not equal according to the contraction mode during maximal voluntary contractions and neurophysiological parameters will be decreased in comparison with non-injured subjects. Secondary objectives are:

  • To analyze the evolution of neurophysiological parameters between sessions interspaced by several months according to the contraction mode.
  • To observe this time evolution depending on the treatment strategy chosen: rehabilitation or surgery plus rehabilitation.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
19mo left

Started Feb 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Feb 2025Dec 2027

First Submitted

Initial submission to the registry

January 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

2.8 years

First QC Date

January 14, 2025

Last Update Submit

January 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Voluntary Activation Level

    Between 2 and 6 weeks after ACL rupture

Secondary Outcomes (5)

  • Maximal voluntary torque

    between 2 to 6 weeks after ACL rupture

  • EMG activity of vastus lateralis, vastus medialis and rectus femoris

    between 2 to 6 weeks after ACL rupture

  • Voluntary Activation Level

    Around 9 months after ACL rupture

  • Maximal voluntary torque

    Around 9 months after ACL rupture

  • EMG activity of vastus lateralis, vastus medialis and rectus femoris

    Around 9 months after ACL rupture

Study Arms (3)

Control

ACL - rehabilitation

ACL - surgery + rehabilitation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will comprise both male and female subjects, divided into three groups. The first group will consist of 20 subjects with isolated (only ACL rupture) or non-isolated ACL rupture (rupture associated with other knee lesion), treated with rehabilitation. The second group will include 20 subjects with ACL rupture, treated with surgery and rehabilitation. A third control group will also be included.

You may qualify if:

  • A. ACL-injured groups (surgically or conservatively treated):
  • Age between 18 and 50 years
  • Free, informed consent signed by the participant and the investigator.
  • Session 1: Delay of 2 to 6 weeks after injury, with a quiet knee (range of motion 110- 0°, minimal effusion, maximal contraction pain ≤ 2/10)
  • Session 2: Duration of 36 to 42 weeks after injury, with a quiet knee (range of motion 110-0°, minimal effusion, maximal contraction pain ≤ 2/10)
  • Independent person (Unprotected: under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision)
  • B. ControlGroup:
  • Age between 18 and 50 years
  • Free, informed consent signed by the participant and the investigator.
  • Sport practitioners: at least once per week practicing activities like collective sports, racket sports, combat sports, skiing, or on-loading activities with changing of directions.
  • Independent person (Unprotected: under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision)

You may not qualify if:

  • \. Subjects fitted with an implanted electronic device such as a cardiac pacemaker 2. Professional athlete 3. Pregnant women 4. Subject with systemic pathology or treatment affecting the musculoskeletal system 5. Subject with a history of neurological pathology or traumatic pathology, or pathology that required orthopedic treatment and/or surgery of the knee, hip and/or lumbar spine 6. Contraindication to isokinetic testing: incapacitating pain, evolving pathological process, non- healed fracture, unbalanced cardiovascular pathology (angina pectoris, arterial hypertension) 7. Contralateral knee injury 8. Subject inability to follow procedures or insufficient knowledge of project language 9. Data acquisition issue or injury during testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Simon Barrué-Belou, PhD

CONTACT

François Fourchet, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist PhD., in charge of Biomechanics

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 20, 2025

Study Start

February 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 20, 2025

Record last verified: 2025-01