Clinical trial NCT06638775: Functional Electrostimulation on the Upper Lip in Multiple Sclerosis
Official title: RESEARCH PROJECT on the APPLICATION of FUNCTIONAL ELECTROSTIMULATION on the UPPER LIMB in MULTIPLE SCLEROSIS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Electrode Site Reaction
Therapy
Directly Observed Therapy
Keywords: fesia grasp
multiple sclerosis
multicampe
therapy
Lead sponsor: Universidad de Burgos
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Be of legal age and sign the informed consent form.
* Not suffer from any pathology in the upper limb such as tendinitis, oedema, fractures, etc.
* Intact skin (no breaks, scratches, cuts, and other superficial or deep injuries) on the arm where the devices will be placed if applicable

Exclusion Criteria:

* Severe medical problems.
* Use of a pacemaker.
* Pregnancy.
* Cutaneous neuropathies.
* Presence of other neuromuscular pathologies.

Primary outcomes:
measure: Nine Hole Peg Test
timeFrame: 3 weeks
measure: Box and Block
timeFrame: 3 weeks
measure: Jamar hand-held dynamometer
timeFrame: 3 weeks
measure: Movement imagery Questionnaire, revisado (MIQ-RS)
timeFrame: 3 weeks
measure: Chronometry
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Burgos
name: Juan Hilario Ortiz phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vázquez Sánchez F. Manual de neurología para terapia ocupacional. García López Beatriz, editor. Madrid: Editorial Medica Panamericana; 2023.