Clinical trial NCT06109025: Improvement of Motor Imaginative Ability Through Functional Electrical Stimulation
Official title: Improvement of Motor Imaginative Ability Through Functional Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Electrode Site Reaction
Therapy, Directly Observed
Lead sponsor: Universidad de Burgos
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nine Hole Peg Test
timeFrame: 1 WEEK
measure: Box and Block:
timeFrame: 1 WEEK
measure: Jamar hand-held dynamometer
timeFrame: 1 WEEK
measure: Movement imagery Questionnaire, revisado (MIQ-RS)
timeFrame: 1 WEEK
measure: Chronometry
timeFrame: 1 WEEK
Secondary outcomes:
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Olalla Saiz Vazquez
Study officials:
affiliation: University of Burgos
name: Montserrat Santamaría Vázquez, PhD
role: PRINCIPAL_INVESTIGATOR
References: