Improvement of Motor Imaginative Ability Through Functional Electrical Stimulation

NCT ID: NCT06109025

Last Updated: 2024-02-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-01-05

Brief Summary

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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

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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.

Conditions

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Electrode Site Reaction Therapy, Directly Observed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

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.

Group Type EXPERIMENTAL

FESIA GRASP

Intervention Type COMBINATION_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 REHAB

Intervention Type COMBINATION_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.

CONTROL GROUP

The sample will be composed mainly, but not exclusively, of adults of legal age, belonging to the group of university students.

Group Type ACTIVE_COMPARATOR

GLOBUS ELITE

Intervention Type COMBINATION_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.

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.

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Burgos

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Spain

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.

Reference Type DERIVED
PMID: 39576986 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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IO 2/2023

Identifier Type: -

Identifier Source: org_study_id

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