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| Name | Class |
|---|---|
| Orthopedic Center Santy, Lyon, France | UNKNOWN |
| Laboratoire Interuniversitaire de Biologie de la Motricité | OTHER |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A session combining motor imagery and listening to low frequency sounds | Other | Prospective study of the efficacy of the Allyane procedure after knee sprain |
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| Measure | Description | Time Frame |
|---|---|---|
| Muscle activity | Electromyography (EMG) during maximal voluntary isometric contraction of leg extension. | Before and 3 weeks after conventional therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Strength | Dynamometer during maximal voluntary isometric contraction of leg extension. | Before and 3 weeks after conventional therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Lysholm Questionnaire | A self-administered survey used to evaluate knee function and stability. | Before and 3 weeks after conventional therapy. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aymeric Guillot, Pr | Laboratoire Interuniversitaire de Biologie de la Motricité | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Expert du Mouvement | Lyon | 69004 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37102673 | Result | 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. |
| Label | URL |
|---|---|
| Additional information about the ALLYANE method, which combines motor imagery and low-frequency sound, can be found on the website: http://allyane.com | View source |
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The shared IPD will include key data points such as demographic information, muscle strength assessment results, functional evaluation scores, and patient-reported outcomes like Lysholm Questionnaire results. Personal identifiers will be removed to ensure participant confidentiality. Data sharing will adhere to ethical and legal requirements. Specifically, the individual participant data sets underlying results in a publication will be shared.
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 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.
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| Standard management - Control group | Other | Active extension (e.g. by lateral raising of the quadriceps, strengthening of the quadriceps) quadriceps) |
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| Standard management - Control group | Other | Flexor inhibition (e.g. massage, hamstring stretching) |
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| Standard management - Control group | Other | Active flexion (e.g. strengthening the flexors) |
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