Improvement of Motor Imaginative Ability Through Functional Electrical Stimulation

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).

Study Overview

• Status: Completed
• Conditions: Electrode Site Reaction; Therapy, Directly Observed
• Intervention / Treatment: Combination product: FESIA GRASP; Combination product: VIRTUAL REHAB; Combination product: GLOBUS ELITE

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Olalla Saiz Vazquez; Phone Number: 625685700; Email: osaiz@ubu.es

Study Locations

• Spain
  • Burgos, Spain, 09003
    • Olalla Saiz Vazquez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXPERIMENTAL GROUP; The sample will be composed mainly, but not exclusively, of adults of legal age, belonging to the group of university students.	Combination product: 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.; Combination product: 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.
Active Comparator: CONTROL GROUP; The sample will be composed mainly, but not exclusively, of adults of legal age, belonging to the group of university students.	Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nine Hole Peg Test	The Nine Hole Peg Test (NHPT) (Mathiowetz et al, 1985), consists of a manual test, in which the subject must place 9 pegs in their corresponding 9 holes, and remove them again, the variable measured being the time it takes to carry out the whole process.	1 WEEK
Box and Block:	The Box and Block scale is a tool with standardised dimensions and materials. It specifies that the subject should sit in front of a rectangular box with his or her hands next to it. The box is constructed of wood with a base 53.7 cm wide and 25.4 cm long; it is divided into two square compartments of 25.4 cm each side separated by a 15.2 cm high divider; both compartments are padded in order to reduce noise during testing. The test contains 150 cube-shaped wooden blocks of 2.5 cm on each side. The number of blocks the subject has carried from one compartment to the other with each hand in one minute of time is to be recorded. Higher scores indicate better manipulative skills.	1 WEEK
Jamar hand-held dynamometer	The Jamar hand dynamometer is used to measure grip strength in the hand, allowing the force exerted by the individual to be converted into a numerical reading. The subject is asked to grip the device and is instructed to perform the maximum sustained contraction. The force is recorded in kilograms.	1 WEEK
Movement imagery Questionnaire, revisado (MIQ-RS)	The MIQ-RS questionnaire (Gregg et al, 2010) consists of 2 subscales, one visual and one kinaesthetic, of 7 items each, each item being scored on a 7-point Likert scale (the higher the score, the easier it is to imagine). For all items, the user is asked to perform a certain motor act (only once), to return to the starting position, and then to imagine it. When scoring the visual scale, the participant is asked to generate an image "as if they could see themselves" doing the gesture, while the kinaesthetic scale asks them to "recall the sensation of the movement". The administration manual specifies that the visual and kinaesthetic items will not be administered consecutively, but are randomly altered to avoid bias. The minimum values are 14, and the maximum values are 98 (minimum 7 and maximum 49 for the subscales).	1 WEEK
Chronometry	Chronometry is defined as the temporal congruence between an executed motor act and the same imagined act. In this case, the NHPT itself is proposed as the motor act executed. So, once administered to obtain the test variable (time taken to perform), the participant will be asked to imagine the performance of the test, and both measures will be timed.	1 WEEK

Collaborators and Investigators

• Sponsor: Universidad de Burgos
• Investigators: Principal Investigator: Montserrat Santamaría Vázquez, PhD, University of Burgos

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): January 5, 2024

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IO 2/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All participants will receive an informed consent form explaining the study to be carried out and the data to be used.
• IPD Sharing Time Frame: Data will be available throughout the intervention with participants for 3 months.
• IPD Sharing Access Criteria: Being a study participant: each participant will be provided with a password to access their informed consent and the research protocol.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No