Improvement of Motor Imaginative Ability Through Functional Electrical Stimulation

Universidad de Burgos

Status and phase: Completed; Early Phase 1

Conditions: Therapy, Directly Observed; Electrode Site Reaction

Treatments: Combination Product: FESIA GRASP; Combination Product: VIRTUAL REHAB; Combination Product: GLOBUS ELITE

Study type: Interventional

Funder types: Other

Identifiers

NCT06109025

IO 2/2023

Details and patient eligibility

About

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).

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 2 patient groups

EXPERIMENTAL GROUP

Experimental group

Description:

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

Treatment:

Combination Product: VIRTUAL REHAB

Combination Product: FESIA GRASP

CONTROL GROUP

Active Comparator group

Description:

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

Treatment:

Combination Product: GLOBUS ELITE