NCT06109025

Improvement of Motor Imaginative Ability Through Functional Electrical Stimulation

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Universidad de Burgos · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Electrode Site Reaction
• Therapy, Directly Observed

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.
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.
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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2023-11-30
• Completion: 2024-01-05
• First posted: 2023-10-31
• Last updated: 2024-02-28

Locations

1 site across 1 country: Spain