Improvement of Motor Imaginative Ability Through Functional Electrical Stimulation
NCT ID: NCT06109025
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
81 participants
INTERVENTIONAL
2023-10-01
2024-01-05
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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EXPERIMENTAL GROUP
The sample will be composed mainly, but not exclusively, of adults of legal age, belonging to the group of university students.
FESIA GRASP
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 REHAB
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.
CONTROL GROUP
The sample will be composed mainly, but not exclusively, of adults of legal age, belonging to the group of university students.
GLOBUS ELITE
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.
Interventions
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FESIA GRASP
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 REHAB
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 ELITE
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Use of a pacemaker.
* Pregnancy.
* Cutaneous neuropathies.
* Presence of other neuromuscular pathologies.
18 Years
35 Years
ALL
Yes
Sponsors
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Universidad de Burgos
OTHER
Responsible Party
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Principal Investigators
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Montserrat Santamaría Vázquez, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Burgos
Locations
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Olalla Saiz Vazquez
Burgos, , Spain
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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IO 2/2023
Identifier Type: -
Identifier Source: org_study_id
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