CompletedEarly Phase 1

Improvement of Motor Imaginative Ability Through Functional Electrical Stimulation

Spain81 participantsStarted 2023-10-01

Plain-language 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).

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Nine Hole Peg Test

Timeframe: 1 WEEK

Box and Block:

Timeframe: 1 WEEK

Jamar hand-held dynamometer

Timeframe: 1 WEEK

Movement imagery Questionnaire, revisado (MIQ-RS)

Timeframe: 1 WEEK

Chronometry

Timeframe: 1 WEEK

Trial details

NCT IDNCT06109025

SponsorUniversidad de Burgos

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-30

View on ClinicalTrials.gov More Electrode Site Reaction trials

Plain-language summary

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.