Clinical trial NCT06774157: Evaluation of the Efficacy of the ALLYANE Procedure in the Treatment of Central Motor Inhibition
Official 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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Arthrogenic Muscle Inhibition
Arthrogenic Muscle Inhibitions
Keywords: AMI
ALLYANE
low frequency sounds
motor imagery
Lead sponsor: Allyane
Sponsor class: INDUSTRY
Collaborators: name: Orthopedic Center Santy, Lyon, France
name: Laboratoire Interuniversitaire de Biologie de la Motricité
First posted: 2025-01-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Muscle activity
timeFrame: Before and 3 weeks after conventional therapy
Secondary outcomes:
measure: Strength
timeFrame: Before and 3 weeks after conventional therapy
Other outcomes:
measure: Lysholm Questionnaire
timeFrame: Before and 3 weeks after conventional therapy.
Locations:
city: Lyon
country: France
facility: Centre Expert du Mouvement
Study officials:
affiliation: Laboratoire Interuniversitaire de Biologie de la Motricité
name: Aymeric Guillot, Pr
role: STUDY_CHAIR
References:
citation: 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.