ACL - Anterior Cruciate Ligament RuptureAMITHENUMNCT07030764
Comparison of Arthrogenic Muscle Inhibition (AMI) After ACL Reconstruction in Patients With Conventional Rehabilitation or Conventional Rehabilitation Combined With Digital Therapy
A study testing DOCT'UP and Physiotherapy in people with ACL - Anterior Cruciate Ligament Rupture, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Traumatic injury to the knee joint, such as rupture of the anterior cruciate ligament (ACL), can compromise the voluntary activation capacity of the quadriceps despite the anatomical integrity of the nerve and muscle structures responsible for contraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACL - Anterior Cruciate Ligament Rupture
- What is being tested?
- DOCT'UP and Physiotherapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2025to 30 Jun 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male or female, aged ≥ 18 years
- Patient with a scheduled primary ACL reconstruction
- Patient with a smartphone and able to use a mobile application on a smartphone
- Patient affiliated to or benefiting from a social security scheme
- French-speaking patient who has signed an informed consent form
Who cannot join
- Patients with residual AMI
- Patient with previous ipsi or contralateral knee surgery
- Patient with a multi-ligament injury
- Patient with contraindications to physical exercise: severe cardiovascular disease or uncontrolled metabolic disease
- Patients with cognitive problems
- Patient without internet access
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- Patient taking part in another study
- Pregnant or breast-feeding women
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Privé Jean Mermoz
Lyon, France, 69008
Benjamin FREYCHET, MD, +33437530708, benjamin.freychet@gmail.com
Benjamin FREYCHET, MD
About this study
Traumatic injury to the knee joint, such as rupture of the anterior cruciate ligament (ACL), can compromise the voluntary activation capacity of the quadriceps despite the anatomical integrity of the nerve and muscle structures responsible for contraction. This phenomenon is commonly known as 'arthrogenic muscle inhibition' (AMI).
AMI is a major limiting factor in recovery and rehabilitation after ACL rupture, and a potential cause of functional disability if left undiagnosed and untreated.
Read more
Traditional rehabilitation protocols for ACL reconstruction do not adequately address the underlying neuromuscular deficits caused by AMI, leading to sub-optimal recovery and prolonged rehabilitation. Furthermore, patient adherence to these protocols, outside of supervised settings, is variable and often poor, which can further delay recovery
Recent advances in digital health technologies offer new ways of improving rehabilitation outcomes. Numerous studies highlight the effectiveness of digital therapies in the form of mobile applications in improving patient engagement and compliance with rehabilitation protocols. In addition, evidence suggests that the integration of these technologies enables faster recovery of muscle function, reduces pain levels, may reduce complications such as Cyclops syndrome and improves overall patient satisfaction with rehabilitation.
Healing has developed a digital therapy called DOCT'UP® which, in addition to physiotherapy sessions, offers support programmes for patients following ACL reconstruction. These programmes include self-education exercises to be carried out at home, some of which specifically target the AMI phenomenon. DOCT'UP® digital therapy has already been used in rehabilitation after ACL reconstruction, with results at 3 weeks on quadriceps activation and post-operative pain, as well as at 1 year on Cyclops syndrome.
Given the limitations of current rehabilitation practices in the context of AMI and the potential of the DOCT'UP® application, there is a clear need to scientifically assess whether the DOCT'UP® application can effectively improve the results of rehabilitation on AMI after ACL reconstruction. This is why the sponsor wishes to set up this Clinical Investigation.
- Conditions
- ACL - Anterior Cruciate Ligament Rupture
- Being tested
- DOCT'UP, Physiotherapy
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOCT'UPDevice
In addition to conventional physiotherapy sessions, DOCT'UP® is a mobile application which offers support programmes for patients following ACL reconstruction. This is digital therapy based on homebased physical exercises to be performed by patient.
PhysiotherapyBehavioural
Physiotherapy includes sessions performed at physiotherapist office under physiotherapist overview
| Study group | Role | What they receive |
|---|---|---|
| Conventional rehabilitation | Other | Conventional rehabilitation includes 40 physiotherapy sessions Receives: Behavioral: Physiotherapy |
| Aaugmented rehabilitation | Experimental | Augmented rehabilitation combines conventional rehabilitation (40 physiotherapy sessions) with the use of DOCT'UP® digital therapy. Receives: Device: DOCT'UP |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMI rate
The rate of patients with an AMI will be defined as a percentage of patients with AMI according to the Sonnery-Cottet classification (Sonnery-Cottet et al, 2022).
Measured: 3 weeks
Physiotherapy adherence
Physiotherapy adherence will include number of physiotherapy sessions per patient
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start25 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL - Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030764
- Sponsor's protocol ID
- 2025-A00730-49
- Acronym
- AMITHENUM
- Status last verified
- Sep 2025
- First submitted
- 12 Jun 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Arthrogenic Muscle Inhibition (AMI) After ACL Reconstruction in Patients With Conventional Rehabilitation or Conventional Rehabilitation Combined With Digital Therapy
- ClinicalTrials.gov ID
- NCT07030764
- Acronym / sponsor ID
- AMITHENUM / 2025-A00730-49
- Conditions
- ACL - Anterior Cruciate Ligament Rupture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Jun 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.
Traumatic injury to the knee joint, such as rupture of the anterior cruciate ligament (ACL), can compromise the voluntary activation capacity of the quadriceps despite the anatomical integrity of the nerve and muscle structures responsible for contraction. This phenomenon is commonly known as 'arthrogenic muscle inhibition' (AMI).
AMI is a major limiting factor in recovery and rehabilitation after ACL rupture, and a potential cause of functional disability if left undiagnosed and untreated.
Traditional rehabilitation protocols for ACL reconstruction do not adequately address the underlying neuromuscular deficits caused by AMI, leading to sub-optimal recovery and prolonged rehabilitation. Furthermore, patient adherence to these protocols, outside of supervised settings, is variable and often poor, which can further delay recovery
Recent advances in digital health technologies offer new ways of improving rehabilitation outcomes. Numerous studies highlight the effectiveness of digital therapies in the form of mobile applications in improving patient engagement and compliance with rehabilitation protocols. In addition, evidence suggests that the integration of these technologies enables faster recovery of muscle function, reduces pain levels, may reduce complications such as Cyclops syndrome and improves overall patient satisfaction with rehabilitation.
Healing has developed a digital therapy called DOCT'UP® which, in addition to physiotherapy sessions, offers support programmes for patients following ACL reconstruction. These programmes include self-education exercises to be carried out at home, some of which specifically target the AMI phenomenon. DOCT'UP® digital therapy has already been used in rehabilitation after ACL reconstruction, with results at 3 weeks on quadriceps activation and post-operative pain, as well as at 1 year on Cyclops syndrome.
Given the limitations of current rehabilitation practices in the context of AMI and the potential of the DOCT'UP® application, there is a clear need to scientifically assess whether the DOCT'UP® application can effectively improve the results of rehabilitation on AMI after ACL reconstruction. This is why the sponsor wishes to set up this Clinical Investigation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional rehabilitation | Other | Behavioral: PhysiotherapyConventional rehabilitation includes 40 physiotherapy sessions |
| Aaugmented rehabilitation | Experimental | Device: DOCT'UPAugmented rehabilitation combines conventional rehabilitation (40 physiotherapy sessions) with the use of DOCT'UP® digital therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient, male or female, aged ≥ 18 years
- Patient with a scheduled primary ACL reconstruction
- Patient with a smartphone and able to use a mobile application on a smartphone
- Patient affiliated to or benefiting from a social security scheme
- French-speaking patient who has signed an informed consent form
Key exclusion criteria (9 listed)
- Patients with residual AMI
- Patient with previous ipsi or contralateral knee surgery
- Patient with a multi-ligament injury
- Patient with contraindications to physical exercise: severe cardiovascular disease or uncontrolled metabolic disease
- Patients with cognitive problems
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 |
|---|---|---|
| DOCT'UPIn addition to conventional physiotherapy sessions, DOCT'UP® is a mobile application which offers support programmes for patients following ACL reconstruction. This is digital therapy based on homebased physical exercises to be performed by patient. | Device | Aaugmented rehabilitation |
| PhysiotherapyPhysiotherapy includes sessions performed at physiotherapist office under physiotherapist overview | Behavioural | Conventional rehabilitation |
Primary outcome
AMI rate
Time frame: 3 weeks
The rate of patients with an AMI will be defined as a percentage of patients with AMI according to the Sonnery-Cottet classification (Sonnery-Cottet et al, 2022).
Physiotherapy adherence
Time frame: 6 months
Physiotherapy adherence will include number of physiotherapy sessions per patient
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 29 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DOCT'UP and Physiotherapy in people with ACL - Anterior Cruciate Ligament Rupture, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 Sep 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?
Contact Benjamin FREYCHET, MD (+33437530708, benjamin.freychet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMI rate (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2025.