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

Allyane

Status: Invitation-only

Conditions: Arthrogenic Muscle Inhibition; Arthrogenic Muscle Inhibitions

Treatments: Other: A session combining motor imagery and listening to low frequency sounds; Other: Standard management - Control group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06774157

AMI_LCA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Standard Management

Active Comparator group

Description:

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.

Treatment:

Other: Standard management - Control group

Other: Standard management - Control group

Other: Standard management - Control group

Standard Management + ALLYANE Process

Experimental group

Description:

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.

Treatment:

Other: Standard management - Control group

Other: Standard management - Control group

Other: A session combining motor imagery and listening to low frequency sounds

Other: Standard management - Control group