Electrode Site ReactionEM/2024NCT06638775
Functional Electrostimulation on the Upper Lip in Multiple Sclerosis
A study testing Fesia Grasp and GLOBUS ELITE in people with Electrode Site Reaction and Therapy, run by Universidad de Burgos.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Electrode Site Reaction, Therapy, Directly Observed Therapy
- What is being tested?
- Fesia Grasp and GLOBUS ELITE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2025to 20 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe medical problems.
- Use of a pacemaker.
- Pregnancy.
- Cutaneous neuropathies.
- Presence of other neuromuscular pathologies.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: RESEARCH PROJECT on the APPLICATION of FUNCTIONAL ELECTROSTIMULATION on the UPPER LIMB in MULTIPLE SCLEROSIS
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.
Read the 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
- Being tested
- Fesia Grasp, GLOBUS ELITE
- Keywords
- fesia grasp, multiple sclerosis, multicampe, therapy
- Medical subject headings
- Directly Observed Therapy, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fesia GraspOther
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.
GLOBUS ELITEOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: GLOBUS ELITE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 Jan 2025 (estimated)
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Electrode Site ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Hilario Ortiz phd, Principal investigator, University of Burgos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638775
- Sponsor's protocol ID
- COPTOCYL/2025
- Other IDs
- IO/102025
- Acronym
- EM/2024
- Status last verified
- Jul 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All participants will receive an informed consent form explaining the study to be carried out and the data to be used.
Publications
Vázquez Sánchez F. Manual de neurología para terapia ocupacional. García López Beatriz, editor. Madrid: Editorial Medica Panamericana; 2023.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESEARCH PROJECT on the APPLICATION of FUNCTIONAL ELECTROSTIMULATION on the UPPER LIMB in MULTIPLE SCLEROSIS
- ClinicalTrials.gov ID
- NCT06638775
- Acronym / sponsor ID
- EM/2024 / COPTOCYL/2025
- Conditions
- Electrode Site Reaction, Therapy, Directly Observed Therapy
- Keywords
- fesia grasp, multiple sclerosis, multicampe, therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | Other: Fesia GraspThe 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. |
| CONTROL GROUP | Experimental | Other: GLOBUS ELITEGlobus 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Severe medical problems.
- Use of a pacemaker.
- Pregnancy.
- Cutaneous neuropathies.
- Presence of other neuromuscular pathologies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fesia GraspThe 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 | EXPERIMENTAL GROUP |
| GLOBUS ELITEis 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 | CONTROL GROUP |
Primary outcome
Nine Hole Peg Test
Time frame: 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.
Box and Block
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- BackgroundVázquez Sánchez F. Manual de neurología para terapia ocupacional. García López Beatriz, editor. Madrid: Editorial Medica Panamericana; 2023.
- Individual participant dataSharing planned: Yes. All participants will receive an informed consent form explaining the study to be carried out and the data to be used.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Hilario Ortiz phd principal investigator
University of Burgos
Questions about this trial
What is this clinical trial studying?
A study testing Fesia Grasp and GLOBUS ELITE in people with Electrode Site Reaction and Therapy, run by Universidad de Burgos.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olalla Saiz Vazquez, phd (625685700, osaiz@ubu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine Hole Peg Test (time frame: 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06638775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.