Clinical trial

Improvement of Motor Imaginative Ability Through Functional Electrical Stimulation

Name

IO 2/2023

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).

Trial arms

Trial start

2023-10-01

Estimated PCD

2023-11-30

Trial end

2024-01-05

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

EXPERIMENTAL GROUP

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.

Arms:

EXPERIMENTAL GROUP

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.

Arms:

CONTROL GROUP

Size

Primary endpoint

Nine Hole Peg Test

1 WEEK

Box and Block:

1 WEEK

Jamar hand-held dynamometer

1 WEEK

Movement imagery Questionnaire, revisado (MIQ-RS)

1 WEEK

Chronometry

1 WEEK

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 81, 'type': 'ACTUAL'}}

Updated at

2024-02-28

1 organization

3 products

3 indications

Indication

directly observed

Organization

Universidad de Burgos

Product

Indication

Indication

Product

Product