NCT06638775

Functional Electrostimulation on the Upper Lip in Multiple Sclerosis

RESEARCH PROJECT on the APPLICATION of FUNCTIONAL ELECTROSTIMULATION on the UPPER LIMB in MULTIPLE SCLEROSIS

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Universidad de Burgos · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Electrode Site Reaction
• Therapy
• Directly Observed Therapy

Interventions

Type	Name	Description
OTHER	Fesia Grasp	The Fesia Grasp device is based on the superficial electrical stimulation of the forearm musculature to provoke flexion and extension movements of the wrist, thumb, index finger and fingers 3, 4 and 5.
OTHER	GLOBUS ELITE	is an electro-stimulator designed for sport and fitness, but with special attention also for beauty treatments thanks to the new sequential stimulation currents, excellent for their draining effects.

Timeline

• Start date: 2025-01-20
• Primary completion: 2025-06-20
• Completion: 2025-09-20
• First posted: 2024-10-15
• Last updated: 2024-10-15