Functional Electrostimulation on the Upper Lip in Multiple Sclerosis

NCT06638775 | Not Yet Recruiting

• 2 other identifiers: COPTOCYL/2025IO/102025
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Electrode Site Reaction; Therapy; Directly Observed Therapy

Keywords

fesia grasp; multiple sclerosis; multicampe; therapy

Outcome Measures

Primary Outcomes (5)

• Nine Hole Peg Test

  The Nine Hole Peg Test (NHPT) (Mathiowetz et al, 1985), consists of a manual test, in which the subject must place 9 pegs in their corresponding 9 holes, and remove them again, the variable measured being the time it takes to carry out the whole process.

  3 weeks

• Box and Block

  The Box and Block scale is a tool with standardised dimensions and materials. It specifies that the subject should sit in front of a rectangular box with his or her hands next to it. The box is constructed of wood with a base 53.7 cm wide and 25.4 cm long; it is divided into two square compartments of 25.4 cm each side separated by a 15.2 cm high divider; both compartments are padded in order to reduce noise during testing. The test contains 150 cube-shaped wooden blocks of 2.5 cm on each side. The number of blocks the subject has carried from one compartment to the other with each hand in one minute of time is to be recorded. Higher scores indicate better manipulative skills.

  3 weeks

• Jamar hand-held dynamometer

  The Jamar hand dynamometer is used to measure grip strength in the hand, allowing the force exerted by the individual to be converted into a numerical reading. The subject is asked to grip the device and is instructed to perform the maximum sustained contraction. The force is recorded in kilograms.

  3 weeks

• Movement imagery Questionnaire, revisado (MIQ-RS)

  The MIQ-RS questionnaire (Gregg et al, 2010) consists of 2 subscales, one visual and one kinaesthetic, of 7 items each, each item being scored on a 7-point Likert scale (the higher the score, the easier it is to imagine). For all items, the user is asked to perform a certain motor act (only once), to return to the starting position, and then to imagine it. When scoring the visual scale, the participant is asked to generate an image "as if they could see themselves" doing the gesture, while the kinaesthetic scale asks them to "recall the sensation of the movement".

  3 weeks

• Chronometry

  Chronometry is defined as the temporal congruence between an executed motor act and the same imagined act. In this case, the NHPT itself is proposed as the motor act executed. So, once administered to obtain the test variable (time taken to perform), the participant will be asked to imagine the performance of the test, and both measures will be timed.

  3 weeks

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

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: Fesia Grasp

CONTROL GROUP

EXPERIMENTAL

Globus elite intervention: 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.

Other: GLOBUS ELITE

Interventions

Fesia Grasp OTHER

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.

EXPERIMENTAL GROUP

GLOBUS ELITE OTHER

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.

CONTROL GROUP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Burgos: lead

Related Publications (1)

• Vázquez Sánchez F. Manual de neurología para terapia ocupacional. García López Beatriz, editor. Madrid: Editorial Medica Panamericana; 2023.

  BACKGROUND

MeSH Terms

Conditions

Directly Observed Therapy; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Juan Hilario Ortiz phd

  University of Burgos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olalla Saiz Vazquez, phd

CONTACT

625685700; osaiz@ubu.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: January 20, 2025
• Primary Completion: June 20, 2025
• Study Completion: September 20, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Data will be available throughout the intervention with participants for 3 months.
• Access Criteria: Being a study participant: each participant will be provided with a password to access their informed consent and the research protocol.