Functional Electrostimulation on the Upper Lip in Multiple Sclerosis

Not Applicable

Not yet recruiting

• Conditions: Electrode Site Reaction; Therapy; Directly Observed Therapy

• Registration Number: NCT06638775
• Lead Sponsor: Universidad de Burgos

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 Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11
• Study Start: 2025-01-20
• Primary Completion: 2025-06-20
• Study Completion: 2025-09-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Box and Block	3 weeks	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.
Jamar hand-held dynamometer	3 weeks	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.
Movement imagery Questionnaire, revisado (MIQ-RS)	3 weeks	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".
Chronometry	3 weeks	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.
Nine Hole Peg Test	3 weeks	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.