Abstract
Study design
Proof of concept.
Objectives
Standard Functional Electrical Stimulation (FES) systems can enhance motor learning in people with tetraplegia and are widely delivered by self-adhesive electrodes. Their limitations are dexterity, specific knowledge to place the electrodes on muscles, need to fix electrodes when they lose the gel layer, and time. We designed a new FES system, using an existing protocol of drinking-like movements, to the upper limb of a person with tetraplegia C5 that fits in any anthropometry and can be easily produced. Furthermore, we tested the system to assess its effectiveness and users’ perception during FES rehabilitation.
Setting
São Carlos, SP, Brazil.
Methods
A shell was designed with parametric design and fast-fabrication methods, and a stimulation unit and a smartphone application were developed. Questionnaires assessed the perceptions of a patient and a physiotherapist, about the usability of the new system in relation to standard FES. Kinematic data of drinking-like movements were collected from the patient wearing both systems and compared with data from an aged-matched control subject.
Results
The results are a personalized shell and an intuitive FES system, overcoming the limitations of standard FES. The new system suggested better wrist-flexion control shown by the mean angles (−18.93°), then the other system (−59.35°), and compared with the control (−10.97°).
Conclusions
Fast-fabrication with parametric design offers a promising alternative for personalizing FES systems, with potential for home use. Further studies are required including randomized clinical trials.

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Acknowledgements
The authors would like to acknowledge the Renato Archer Information Technology Center in particular Jorge Vicente Lopes da Silva, Pedro Yoshito Noritomi and Leonardo Mendes Ribeiro Machado for their assistance with 3D technologies, and Janiele Rossi and Geruza Perlato Bella for assistance in physiotherapy, and Dr. Mauro Masili, from University of São Paulo, for his valuable discussions and critical reading of the article.
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FAPESP (2017/06147-4 and 2016/50253-0), Capes (88882.379203/2019-01), and CNPq.
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All authors conceived and designed the study that led to the submission of this paper, acquired data, and played an important role in the interpretation of the results. All authors wrote, reviewed the manuscript, and approved the final version, and also agreed to be responsible for all its aspects for ensuring issues on the accuracy or completeness of any part would be properly investigated and resolved.
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Ventura, A., Bataglia, J.M.P., Ginja, G. et al. Design and fast-fabrication of a system for functional electrical stimulation in upper limb of people with tetraplegia. Spinal Cord Ser Cases 8, 54 (2022). https://doi.org/10.1038/s41394-022-00519-5
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DOI: https://doi.org/10.1038/s41394-022-00519-5