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

NCT06774157 | Enrolling By Invitation

• 1 other identifier: AMI_LCA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthrogenic Muscle Inhibition; Arthrogenic Muscle Inhibitions

Keywords

AMI; ALLYANE; low frequency sounds; motor imagery

Outcome Measures

Primary Outcomes (1)

• Muscle activity

  Electromyography (EMG) during maximal voluntary isometric contraction of leg extension.

  Before and 3 weeks after conventional therapy

Secondary Outcomes (1)

• Strength

  Before and 3 weeks after conventional therapy

Other Outcomes (1)

• Lysholm Questionnaire

  Before and 3 weeks after conventional therapy.

Study Arms (2)

Standard Management

ACTIVE COMPARATOR

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

Standard Management + ALLYANE Process

EXPERIMENTAL

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; Other: Standard management - Control group

Interventions

A session combining motor imagery and listening to low frequency sounds OTHER

Prospective study of the efficacy of the Allyane procedure after knee sprain

Also known as: ALLYANE, Motor imagery, low frequency sounds

Standard Management + ALLYANE Process

Standard management - Control group OTHER

Active extension (e.g. by lateral raising of the quadriceps, strengthening of the quadriceps) quadriceps)

Standard Management; Standard Management + ALLYANE Process

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Algodystrophy

Sponsors & Collaborators

• Allyane: lead
• Orthopedic Center Santy, Lyon, France: collaborator
• Laboratoire Interuniversitaire de Biologie de la Motricité: collaborator

Study Sites (1)

Centre Expert du Mouvement

Lyon, 69004, France

Location

Related Publications (1)

• Dos Anjos T, Gabriel F, Vieira TD, Hopper GP, Sonnery-Cottet B. Neuromotor Treatment of Arthrogenic Muscle Inhibition After Knee Injury or Surgery. Sports Health. 2024 May-Jun;16(3):383-389. doi: 10.1177/19417381231169285. Epub 2023 Apr 27.

  PMID: 37102673 BACKGROUND

Related Links

• Additional information about the ALLYANE method, which combines motor imagery and low-frequency sound, can be found on the website: http://allyane.com

Study Officials

• Aymeric Guillot, Pr

  Laboratoire Interuniversitaire de Biologie de la Motricité

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: January 14, 2025
• Study Start: January 15, 2024
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

FR (1)