Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638775
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Functional Electrostimulation on the Upper Lip in Multiple Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
RESEARCH PROJECT on the APPLICATION of FUNCTIONAL ELECTROSTIMULATION on the UPPER LIMB in MULTIPLE SCLEROSIS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EM2024
Brief Summary:
Multiple sclerosis MS is an autoimmune disease where immune cells attack the body triggering an inflammatory response A study comparing multifield FES and conventional FES on upper extremity motor skills and functional independence in MS patients will be conducted Results suggest that both types of FES treatments normalize muscle tone showing superior results compared to those without FES therapy The study aims to compare the effects of both types on MS patients
Detailed Description:
Multiple sclerosis MS is an autoimmune disease in which cells of the immune system attack the body itself This condition generates an activation of the immune system that triggers an inflammatory response General objective To compare the effect of multifield FES and conventional FES on upper extremity motor skills and functional independence in people with MS Methodology A three-arm prospective longitudinal multicenter randomized controlled trial RCT will be conducted conventional therapy Control Group CG an experimental group 1 EG1 which in addition to this same treatment will use the conventional FES tool through the Globus Elite device and an experimental group 2 EG2 which will differ from GE1 in that it will use the FES multi-field device through FESIA Grasp Results It is expected that people who have used any type of FES will have a more normalized muscle tone compared to those who have not received this type of treatment The research compares the effects of two types of FES in people with multiple sclerosis focusing on improved motor skills and functional independence Both FES treatments are expected to normalize muscle tone showing superior results compared to those who do not receive this therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None