Arthrogenic Muscle InhibitionNCT06774157
Evaluation of the Efficacy of the ALLYANE Procedure in the Treatment of Central Motor Inhibition
A study testing A session combining motor imagery and listening to low frequency sounds in people with Arthrogenic Muscle Inhibition and Arthrogenic Muscle Inhibitions, run by Allyane at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Arthrogenic Muscle Inhibition, Arthrogenic Muscle Inhibitions
- What is being tested?
- A session combining motor imagery and listening to low frequency sounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2024to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
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:
Read more
- 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.
Read the 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.
- Being tested
- A session combining motor imagery and listening to low frequency sounds, Standard management - Control group
- Keywords
- AMI, ALLYANE, low frequency sounds, motor imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A session combining motor imagery and listening to low frequency soundsOther
Also called ALLYANE, Motor imagery, low frequency sounds
Prospective study of the efficacy of the Allyane procedure after knee sprain
Standard management - Control groupOther
Active extension (e.g. by lateral raising of the quadriceps, strengthening of the quadriceps) quadriceps)
Standard management - Control groupOther
Flexor inhibition (e.g. massage, hamstring stretching)
Standard management - Control groupOther
Active flexion (e.g. strengthening the flexors)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard management - Control group |
| 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. Receives: Other: A session combining motor imagery and listening to low frequency sounds; Other: Standard management - Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activity
Electromyography (EMG) during maximal voluntary isometric contraction of leg extension.
Measured: Before and 3 weeks after conventional therapy
Secondary outcomes (1)
Strength
Dynamometer during maximal voluntary isometric contraction of leg extension.
Measured: Before and 3 weeks after conventional therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start15 Jan 2024
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthrogenic Muscle InhibitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allyane
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orthopedic Center Santy, Lyon, France, Laboratoire Interuniversitaire de Biologie de la Motricité
- Responsible party
- Sponsor
- Investigators
- Aymeric Guillot, Pr, Study chair, Laboratoire Interuniversitaire de Biologie de la Motricité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774157
- Sponsor's protocol ID
- AMI_LCA
- Status last verified
- Mar 2025
- First submitted
- 7 Oct 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37102673
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06774157
- Acronym / sponsor ID
- AMI_LCA
- Keywords
- AMI, ALLYANE, low frequency sounds, motor imagery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- AllyaneIndustry (pharma, biotech, devices)
- Collaborators
- Orthopedic Center Santy, Lyon, France, Laboratoire Interuniversitaire de Biologie de la Motricité
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Management | Active comparator | Other: Standard management - Control groupThis 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. |
| Standard Management + ALLYANE Process | Experimental | Other: A session combining motor imagery and listening to low frequency sounds, Other: Standard management - Control groupThis 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A session combining motor imagery and listening to low frequency soundsAlso: ALLYANE, Motor imagery, low frequency soundsProspective study of the efficacy of the Allyane procedure after knee sprain | Other | Standard Management + ALLYANE Process |
| Standard management - Control groupActive extension (e.g. by lateral raising of the quadriceps, strengthening of the quadriceps) quadriceps) | Other | Standard Management, Standard Management + ALLYANE Process |
| Standard management - Control groupFlexor inhibition (e.g. massage, hamstring stretching) | Other | Standard Management, Standard Management + ALLYANE Process |
| Standard management - Control groupActive flexion (e.g. strengthening the flexors) | Other | Standard Management, Standard Management + ALLYANE Process |
Primary outcome
Muscle activity
Time frame: Before and 3 weeks after conventional therapy
Electromyography (EMG) during maximal voluntary isometric contraction of leg extension.
1 secondary outcome
Strength
Time frame: Before and 3 weeks after conventional therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Results publication: PubMed 37102673Dos 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.
- Additional information about the ALLYANE method, which combines motor imagery and low-frequency sound, can be found on the website: http://allyane.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Arthrogenic Muscle Inhibition
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Active, not recruiting
Effect of Surface EMG Biofeedback on Quadriceps Inhibition Release During Postoperative Knee Rehabilitation
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Brain-Computer Interface Visualization Training to Optimize Muscle Activation Following Orthopaedic Surgery
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Comparison of Arthrogenic Muscle Inhibition (AMI) After ACL Reconstruction in Patients With Conventional Rehabilitation or Conventional Rehabilitation Combined With Digital Therapy
ACL - Anterior Cruciate Ligament Rupture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aymeric Guillot, Pr study chair
Laboratoire Interuniversitaire de Biologie de la Motricité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A session combining motor imagery and listening to low frequency sounds in people with Arthrogenic Muscle Inhibition and Arthrogenic Muscle Inhibitions, run by Allyane at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle activity (time frame: Before and 3 weeks after conventional therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06774157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.