Improvement of Motor Imagination and Manual Ability Through Virtual Reality and Selective and Nonselective Functional Electrical Stimulation: Protocol for a Randomized Controlled Trial.

Background: Motor imagery (MI) is a cognitive process that has been shown to be useful in the rehabilitation process after brain injury. Moreover, functional electrical stimulation (FES) and virtual reality (VR) have also been shown to be effective interventions in many parameters, and there is some evidence of their contribution to the improvement of MI capacity.

Objective: This study aimed to compare the improvements in MI parameters, grip strength, and manual dexterity obtained using VR, FES, and selective FES based on multifield electrodes in healthy people.

Methods: This clinical randomized controlled trial (RCT)with 4 branches will involve 80 healthy university students, with blinded third-party assessment. Participants will be divided into 4 groups: control (no intervention), selective FES (Fesia Grasp), traditional FES (Globus Elite), and Virtual Rehab Hands (Leap Motion sensor). Each group will receive 5 daily sessions, and assessments will be conducted at baseline, postintervention, and follow-up. The Movement Imagery Questionnaire-Revised (MIQ-RS) and chronometry will be used to assess MI, strength will be measured with a digital dynamometer, and manual dexterity will be evaluated with the Nine Hole Peg Test (NHPT) and the Box and Block Test (BBT). Statistical analyses will include 2-way repeated-measures ANOVA with post hoc Bonferroni correction to compare group differences over time, with nonparametric tests (eg, Kruskal-Wallis) being used if normality or variance assumptions are violated. The study will be organized into 3 phases: preparation, data collection, and analysis. The preparation phase will involve finalizing project protocols and obtaining ethical approvals. The data collection phase will consist of recruiting participants, randomizing them into 4 intervention groups, and conducting baseline assessments, followed by intervention sessions. Finally, the analysis phase will focus on evaluating the data collected from all groups and compiling the results for presentation.

Results: The study received approval in July 2023, with recruitment and data collection starting in September 2023. The recruitment phase was expected to conclude by July 2024, and the entire study, including the 2-week follow-up, was set to finish in September 2024. As of July 2024, we had enrolled 100% of the sample (N=80 students). We plan to publish the study findings by the end of 2024.

Conclusions: Improvements in MI and upper limb functionality are expected, particularly in the selective FES group. This RCT will identify which intervention is most effective in enhancing these skills, with potential benefits for patients with neurological motor disorders.

Trial registration: ClinicalTrials.gov NCT06109025; https://clinicaltrials.gov/study/NCT06109025.

International registered report identifier (irrid): DERR1-10.2196/63329.