Evaluation of the Efficacy of the ALLYANE Procedure in the Treatment of Central Motor Inhibition (NCT06774157) | Clinical Trial Compass
By InvitationNot Applicable
Evaluation of the Efficacy of the ALLYANE Procedure in the Treatment of Central Motor Inhibition
France120 participantsStarted 2024-01-15
Plain-language 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.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Muscle activity
Timeframe: Before and 3 weeks after conventional therapy