Evaluation of the Efficacy of the ALLYANE Procedure in the Treatment of Central Motor Inhibition

March 5, 2025 updated by: Allyane

Evaluation of the Efficacy of the ALLYANE Procedure in the Treatment of Central Motor Inhibition Immediately After Knee Sprain As an Adjunct to Conventional Treatment.

The goal of this clinical study is to determine the effectiveness of restoring muscle strength in the management of motor inhibition when complemented by the ALLYANE process (neuro-motor reprogramming) compared to a standard management approach.

The main questions it aims to answer are:

  • Does the ALLYANE process lead to greater muscle strength gains compared to standard care?
  • Is there a functional benefit when standard management is complemented by the ALLYANE process?

The investigators will compare the group receiving standard care complemented by ALLYANE to a group receiving only standard care to evaluate if the ALLYANE process provides additional effects.

Participants will:

  • Undergo assessments of muscle strength.
  • Receive either standard management or standard management with ALLYANE.
  • Complete functional evaluations before and after treatment.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate the effectiveness of motor inhibition management using two different approaches: standard management alone and standard management supplemented by the ALLYANE neuro-motor reprogramming process. To ensure robust and reliable results, the study proposes enrolling a total of 120 patients, divided into two groups of 60 patients each.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Centre Expert du Mouvement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men and women aged 18 to 35 years
  • No neurological history
  • Have had a primary knee sprain
  • Present with VMO lateralisation with or without the presence of flessum
  • Quadricipital weakness between the healthy and injured limb of 50% or more as measured by a portable dynamometer
  • Member of a social security scheme

Exclusion Criteria:

  • Recurrent sprain
  • Bilateral sprain
  • Persons under guardianship, trusteeship or any other measure depriving them of their rights or liberty, and adults protected by law.
  • Persons who do not understand French
  • Knee trauma other than sprain
  • Exclusion criteria for the Allyane procedure (COPHOSIS, cognitive difficulties, purely mechanical limitation)
  • Algodystrophy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Management
This group of patients will receive the conventional approach for managing motor inhibitions, which may include traditional physical therapy, exercises, and other rehabilitative techniques without any additional intervention.
Other: Standard management - Control group
Active extension (e.g. by lateral raising of the quadriceps, strengthening of the quadriceps) quadriceps)
Other: Standard management - Control group
Flexor inhibition (e.g. massage, hamstring stretching)
Other: Standard management - Control group
Active flexion (e.g. strengthening the flexors)
Experimental: Standard Management + ALLYANE Process
This group will receive the same standard management as the first group but with the addition of the ALLYANE process, a neuro-motor reprogramming technique designed to enhance muscle activation and re-establish motor control.
Other: A session combining motor imagery and listening to low frequency sounds
Prospective study of the efficacy of the Allyane procedure after knee sprain
Other Names:
  • Motor imagery
  • ALLYANE
  • low frequency sounds
Other: Standard management - Control group
Active extension (e.g. by lateral raising of the quadriceps, strengthening of the quadriceps) quadriceps)
Other: Standard management - Control group
Flexor inhibition (e.g. massage, hamstring stretching)
Other: Standard management - Control group
Active flexion (e.g. strengthening the flexors)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle activity
Time Frame: Before and 3 weeks after conventional therapy
Electromyography (EMG) during maximal voluntary isometric contraction of leg extension.
Before and 3 weeks after conventional therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strength
Time Frame: Before and 3 weeks after conventional therapy
Dynamometer during maximal voluntary isometric contraction of leg extension.
Before and 3 weeks after conventional therapy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lysholm Questionnaire
Time Frame: Before and 3 weeks after conventional therapy.
A self-administered survey used to evaluate knee function and stability.
Before and 3 weeks after conventional therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allyane

Collaborators

Orthopedic Center Santy, Lyon, France
Laboratoire Interuniversitaire de Biologie de la Motricité

Investigators

  • Study Chair: Aymeric Guillot, Pr, Laboratoire Interuniversitaire de Biologie de la Motricité

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 20, 2026

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AMI_LCA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The shared IPD will include key data points such as demographic information, muscle strength assessment results, functional evaluation scores, and patient-reported outcomes like Lysholm Questionnaire results. Personal identifiers will be removed to ensure participant confidentiality. Data sharing will adhere to ethical and legal requirements. Specifically, the individual participant data sets underlying results in a publication will be shared.

IPD Sharing Time Frame

The IPD and supporting information will be made available starting after statistical analysis is complete and during the process of writing the manuscript for publication. The data will remain accessible for a period of three years following the publication of the study results.

IPD Sharing Access Criteria

Access to the IPD and supporting information will be granted to qualified researchers affiliated with academic, governmental, or non-profit institutions. They will have access to de-identified individual participant data, including demographic details, muscle strength assessments, functional evaluation results, and patient-reported outcomes. Access will be provided through a secure repository or data-sharing platform after approval of a data-sharing agreement. Researchers must agree to use the data solely for academic and non-commercial purposes, comply with all ethical guidelines, and acknowledge the source in any resulting publications.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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