NCT06109025

Improvement of Motor Imaginative Ability Through Functional Electrical Stimulation

Completed EARLY_PHASE1 Last updated 28 February 2024

What this trial tests

EARLY_PHASE1 trial testing FESIA GRASP in Electrode Site Reaction in 81 participants. Completed in 5 January 2024.

Timeline

1 October 2023

Primary endpoint
30 November 2023

5 January 2024

Quick facts

Lead sponsor	Universidad de Burgos
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	basic science
Enrollment	81
Start date	1 October 2023
Primary completion	30 November 2023
Estimated completion	5 January 2024
Sites	1 location across Spain

Drugs / interventions tested

• FESIA GRASP
• VIRTUAL REHAB
• GLOBUS ELITE

Conditions studied

• Electrode Site Reaction — all drugs for Electrode Site Reaction →
• Therapy, Directly Observed — all drugs for Therapy, Directly Observed →

Sponsor

Universidad de Burgos

Who can join

Adults 18 to 35, any sex, with Electrode Site Reaction or Therapy, Directly Observed. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Improvement of Motor Imagination and Manual Ability Through Virtual Reality and Selective and Nonselective Functional Electrical Stimulation: Protocol for a Randomized Controlled Trial.
   Santamaría-Vázquez M, Ortiz-Huerta JH, Martín-Odriozola A, Saiz-Vazquez O. · · 2024 · PMID 39576986 · DOI 10.2196/63329