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Enrolling by Invitation

NCT Number: NCT06774157

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

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.

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Key information

Conditions

Arthrogenic Muscle Inhibition Arthrogenic Muscle Inhibitions

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Expert du Mouvement

Lyon, 69004, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A session combining motor imagery and listening to low frequency sounds

Other

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

Other names: ALLYANE, Motor imagery, low frequency sounds

Standard management - Control group

Other

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

Primary outcomes

  1. Muscle activity

    Time frame: Before and 3 weeks after conventional therapy

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

Secondary outcomes

  1. Strength

    Time frame: Before and 3 weeks after conventional therapy

    Dynamometer during maximal voluntary isometric contraction of leg extension.

Other outcomes

  1. Lysholm Questionnaire

    Time frame: Before and 3 weeks after conventional therapy.

    A self-administered survey used to evaluate knee function and stability.

Sponsors and collaborators

Lead sponsor

Allyane

Industry

Collaborators

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

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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