Electrode Site ReactionEarly Phase 1NCT06109025
Improvement of Motor Imaginative Ability Through Functional Electrical Stimulation
A Early Phase 1 study testing FESIA GRASP, VIRTUAL REHAB and GLOBUS ELITE in people with Electrode Site Reaction and Therapy, Directly Observed, run by Universidad de Burgos at 1 site in Spain.
Trial summary
This is a experimental, randomised, parallel-group, clinical study. A sample of university students will be divided into 4 groups, where one of them will act as a control group (no intervention), and the other three will undergo hand training with two different types of functional electrical stimulation devices and a… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Electrode Site Reaction, Therapy, Directly Observed
- What is being tested?
- FESIA GRASP, VIRTUAL REHAB and GLOBUS ELITE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2023to 5 Jan 2024
- Phase
- Early Phase 1
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- 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
1 site in 1 country.
About this study
This is a experimental, randomised, parallel-group, clinical study.
A sample of university students will be divided into 4 groups, where one of them will act as a control group (no intervention), and the other three will undergo hand training with two different types of functional electrical stimulation devices and a final group will receive hand training with video games.
Read more
Inter-group analyses will be performed before the start of the training (pre-intervention), after the end of the programme (post-intervention), and three weeks after the end of the programme (follow-up assessment). Intra-group analyses will also be carried out to check whether the training has led to an improvement in the quality of motor imagination, as well as an improvement in manual dexterity in each of the groups.
In order to carry out the project, a collaboration agreement will be signed with the company FESIA
TECHNOLOGY S.L, which will provide a FESIA GRASP device for the study, as well as the consumables (electrodes).
Read the detailed description
The study aims to answer the research question:
P: healthy adults I: FES and, FES multi-field. C: video games O: Motor imagination, strength, manual dexterity.
The aim is to compare different tools in a population sector to see if there is an improvement in motor skills through the use of these devices.
General objective: To test the effects of functional electrical stimulation and virtual reality with respect to motor imagination, strength and manual dexterity.
Secondary objectives:
To find out whether functional electrical stimulation improves motor imagination, both kinaesthetic and visual, as well as manual dexterity and strength.
To find out if an intervention based on the use of virtual reality improves motor imagination, both kinaesthetic and visual, as well as manual dexterity.
To test whether there are differences between functional electrical stimulation, multi-field functional electrical stimulation and virtual reality in terms of visual motor imagination, kinaesthetic imagination and manual dexterity.
- Being tested
- FESIA GRASP, VIRTUAL REHAB, GLOBUS ELITE
- Medical subject headings
- Directly Observed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FESIA GRASPCombination product
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.
VIRTUAL REHABCombination product
VirtualRehab is a therapeutic physical rehabilitation tool that uses virtual reality to provide therapy for patients with neurological or musculoskeletal disorders; providing a wide range of activities designed to improve mobility, coordination and strength.
GLOBUS ELITECombination product
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 sample will be composed mainly, but not exclusively, of adults of legal age, belonging to the group of university students. Receives: Combination Product: FESIA GRASP; Combination Product: VIRTUAL REHAB |
| CONTROL GROUP | Active comparator | The sample will be composed mainly, but not exclusively, of adults of legal age, belonging to the group of university students. Receives: Combination Product: 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: 1 WEEK
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: 1 WEEK
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: 1 WEEK
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".
The administration manual specifies that the visual and kinaesthetic items will not be administered consecutively, but are randomly altered to avoid bias.
The minimum values are 14, and the maximum values are 98 (minimum 7 and maximum 49 for the subscales).
Measured: 1 WEEK
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: 1 WEEK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Oct 2023
- Primary completion30 Nov 2023
- Study completion5 Jan 2024
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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Montserrat Santamaría Vázquez, PhD, Principal investigator, University of Burgos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109025
- Sponsor's protocol ID
- IO 2/2023
- Status last verified
- Feb 2024
- First submitted
- 16 Oct 2023
- Last updated
- 28 Feb 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
Santamaria-Vazquez M, Ortiz-Huerta JH, Martin-Odriozola A, Saiz-Vazquez O. Improvement of Motor Imagination and Manual Ability Through Virtual Reality and Selective and Nonselective Functional Electrical Stimulation: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 22;13:e63329. doi: 10.2196/63329.
PubMed 39576986
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Motor Imaginative Ability Through Functional Electrical Stimulation
- ClinicalTrials.gov ID
- NCT06109025
- Acronym / sponsor ID
- IO 2/2023
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 31 Oct 2023 (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.
This is a experimental, randomised, parallel-group, clinical study.
A sample of university students will be divided into 4 groups, where one of them will act as a control group (no intervention), and the other three will undergo hand training with two different types of functional electrical stimulation devices and a final group will receive hand training with video games.
Inter-group analyses will be performed before the start of the training (pre-intervention), after the end of the programme (post-intervention), and three weeks after the end of the programme (follow-up assessment). Intra-group analyses will also be carried out to check whether the training has led to an improvement in the quality of motor imagination, as well as an improvement in manual dexterity in each of the groups.
In order to carry out the project, a collaboration agreement will be signed with the company FESIA
TECHNOLOGY S.L, which will provide a FESIA GRASP device for the study, as well as the consumables (electrodes).
Detailed description
The study aims to answer the research question:
P: healthy adults I: FES and, FES multi-field. C: video games O: Motor imagination, strength, manual dexterity.
The aim is to compare different tools in a population sector to see if there is an improvement in motor skills through the use of these devices.
General objective: To test the effects of functional electrical stimulation and virtual reality with respect to motor imagination, strength and manual dexterity.
Secondary objectives:
To find out whether functional electrical stimulation improves motor imagination, both kinaesthetic and visual, as well as manual dexterity and strength.
To find out if an intervention based on the use of virtual reality improves motor imagination, both kinaesthetic and visual, as well as manual dexterity.
To test whether there are differences between functional electrical stimulation, multi-field functional electrical stimulation and virtual reality in terms of visual motor imagination, kinaesthetic imagination and manual dexterity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | Combination Product: FESIA GRASP, Combination Product: VIRTUAL REHABThe sample will be composed mainly, but not exclusively, of adults of legal age, belonging to the group of university students. |
| CONTROL GROUP | Active comparator | Combination Product: GLOBUS ELITEThe sample will be composed mainly, but not exclusively, of adults of legal age, belonging to the group of university students. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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. | Combination product | EXPERIMENTAL GROUP |
| VIRTUAL REHABVirtualRehab is a therapeutic physical rehabilitation tool that uses virtual reality to provide therapy for patients with neurological or musculoskeletal disorders; providing a wide range of activities designed to improve mobility, coordination and strength. | Combination product | 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. | Combination product | CONTROL GROUP |
Primary outcome
Nine Hole Peg Test
Time frame: 1 WEEK
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: 1 WEEK
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: 1 WEEK
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: 1 WEEK
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". The administration manual specifies that the visual and kinaesthetic items will not be administered consecutively, but are randomly altered to avoid bias. The minimum values are 14, and the maximum values are 98 (minimum 7 and maximum 49 for the subscales).
Chronometry
Time frame: 1 WEEK
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 39576986Santamaria-Vazquez M, Ortiz-Huerta JH, Martin-Odriozola A, Saiz-Vazquez O. Improvement of Motor Imagination and Manual Ability Through Virtual Reality and Selective and Nonselective Functional Electrical Stimulation: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 22;13:e63329. doi: 10.2196/63329.
- 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.
Montserrat Santamaría Vázquez, PhD principal investigator
University of Burgos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing FESIA GRASP, VIRTUAL REHAB and GLOBUS ELITE in people with Electrode Site Reaction and Therapy, Directly Observed, run by Universidad de Burgos at 1 site in Spain.
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: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine Hole Peg Test (time frame: 1 WEEK). 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 NCT06109025, 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 28 Feb 2024.