Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-25 @ 4:29 PM
Study NCT ID:
NCT06774157
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-07
First Post:
2024-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of the ALLYANE Procedure in the Treatment of Central Motor Inhibition
Sponsor:
Allyane
Organization:
Study Overview
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.
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: