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

Not Applicable

• Conditions: Arthrogenic Muscle Inhibition; Arthrogenic Muscle Inhibitions

• Registration Number: NCT06774157
• Lead Sponsor: Allyane

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.

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 Timeline

• Study Start: 2024-01-15
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2025-01-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-12-20
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Muscle activity	Before and 3 weeks after conventional therapy	Electromyography (EMG) during maximal voluntary isometric contraction of leg extension.

Secondary Outcome Measures

Name	Time	Method
Strength	Before and 3 weeks after conventional therapy	Dynamometer during maximal voluntary isometric contraction of leg extension.

Trial Locations

Locations (1)

Centre Expert du Mouvement; 🇫🇷 Lyon, France