| Registry | NCT07767955 |
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| Status | Completed |
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| Study type | Observational |
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| Enrollment | 14 (Actual) |
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| Sponsor | University of Sao Paulo General Hospital (Other); collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico |
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| Conditions | Paraplegia and Tetraplegia |
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| Interventions | Exoskeleton (Device) |
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| Dates | start 2024-10-01, primary completion 2025-11-01, completion 2025-11-01, first posted 2026-08-17, last updated 2026-08-17 |
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| Locations | 1 site in Brazil |
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Related Papers Related Patents Related Grants Related Experts
All trials for Paraplegia and Tetraplegia All trials of Exoskeleton
-Summary
The recent increase in the use of exoskeletons in rehabilitation therapies is bringing important changes to the healthcare professional's work routine. However, despite the importance of user feedback on the development of these novelties, research on this topic remains scarce. The purpose of this study was to compare the satisfaction of healthcare professionals (physiotherapists and physical education instructors) with different exoskeletons. This exploratory case series evaluated healthcare professionals' perspectives and compared the usability of 3 different exoskeleton devices used for gait trainning. A group of 14 rehabilitation specialists with at least six months of experience in exoskeleton operation were interviewed to evaluate qualitative aspects and answered a System Usability Scale (SUS) questionnaire.
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+Arms and interventions
- Exoskeleton (Device), also known as LokomatPro FreeD module: Grounded exoskeleton
- Exoskeleton (Device), also known as Atalante X: Autonomous wearable exoskeleton
- Exoskeleton (Device): Wearable device that requires clutches
+Outcome measures
Primary outcomes
- User satisfaction [When the participant completed 6 months of experience with the device]: A System Usability Scale questionnaire was applied in order to asses a quantitative score for each device
+Eligibility
Sex: All
Inclusion Criteria:
* Healthcare professionals (HCP) specialized in rehabilitation, with a minimum of six months of experience in exoskeleton operation for the treatment of adult patients with different levels of lower limb impairments.
Exclusion Criteria:
* Not being a rehabilitation specialist, having less than six months of experience with the device
+Locations (1)
| Facility | City | Country | Status |
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| Hospital das Clínicas da Faculdade de Medicina da USP | São Paulo, São Paulo | Brazil | |
+Publications
- R Core Team (2025). _R: A Language and Environment for Statistical Computing_. R Foundation for Statistical Computing, Vienna, Austria. <https://www.R-project.org/>
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- Brooke J. SUS: a quick and dirty usability scale. Usability Eval Ind. 1996;189:4-7.
- Padrini-Andrade L, Balda RCX, Areco KCN, Bandiera-Paiva P, Nunes MDV, Marba STM, Carvalho WB, Rugolo LMSS, Almeida JHC, Procianoy RS, Duarte JLMB, Rego MAS, Ferreira DMLM, Alves Filho N, Guinsburg R, Diniz EMA, Santos JPFD, Testoni D, Silva NMME, Gonzales MRC, Silva RVCD, Meneses J, Goncalves-Ferri WA, Perussi-E-Silva R, Bomfim O. EVALUATION OF USABILITY OF A NEONATAL HEALTH INFORMATION SYSTEM ACCORDING TO THE USER'S PERCEPTION. Rev Paul Pediatr. 2019 Jan-Mar;37(1):90-96. doi: 10.1590/1984-0462/;2019;37;1;00019. Epub 2018 Dec 13. PMID 30569950
- Shapkova EY, Pismennaya EV, Emelyannikov DV, Ivanenko Y. Exoskeleton Walk Training in Paralyzed Individuals Benefits From Transcutaneous Lumbar Cord Tonic Electrical Stimulation. Front Neurosci. 2020 May 25;14:416. doi: 10.3389/fnins.2020.00416. eCollection 2020. PMID 32528238
- Elmas Bodur B, Erdoganoglu Y, Asena Sel S. Effects of robotic-assisted gait training on physical capacity, and quality of life among chronic stroke patients: A randomized controlled study. J Clin Neurosci. 2024 Feb;120:129-137. doi: 10.1016/j.jocn.2024.01.010. Epub 2024 Jan 18. PMID 38241771
- Kerdraon J, Previnaire JG, Tucker M, Coignard P, Allegre W, Knappen E, Ames A. Evaluation of safety and performance of the self balancing walking system Atalante in patients with complete motor spinal cord injury. Spinal Cord Ser Cases. 2021 Aug 4;7(1):71. doi: 10.1038/s41394-021-00432-3. PMID 34349101
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- Zhang L, Lin F, Sun L, Chen C. Comparison of Efficacy of Lokomat and Wearable Exoskeleton-Assisted Gait Training in People With Spinal Cord Injury: A Systematic Review and Network Meta-Analysis. Front Neurol. 2022 Apr 13;13:772660. doi: 10.3389/fneur.2022.772660. eCollection 2022. PMID 35493806
- Mortenson WB, Pysklywec A, Chau L, Prescott M, Townson A. Therapists' experience of training and implementing an exoskeleton in a rehabilitation centre. Disabil Rehabil. 2022 Apr;44(7):1060-1066. doi: 10.1080/09638288.2020.1789765. Epub 2020 Jul 10. PMID 32649239
- Mertz L. The next generation of exoskeletons: lighter, cheaper devices are in the works. IEEE Pulse. 2012 Jul;3(4):56-61. doi: 10.1109/MPUL.2012.2196836. PMID 22850839
- Louie DR, Eng JJ. Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. J Neuroeng Rehabil. 2016 Jun 8;13(1):53. doi: 10.1186/s12984-016-0162-5. PMID 27278136
- Lajeunesse V, Vincent C, Routhier F, Careau E, Michaud F. Exoskeletons' design and usefulness evidence according to a systematic review of lower limb exoskeletons used for functional mobility by people with spinal cord injury. Disabil Rehabil Assist Technol. 2016 Oct;11(7):535-47. doi: 10.3109/17483107.2015.1080766. Epub 2015 Sep 4. PMID 26340538
- Vaughan-Graham J, Brooks D, Rose L, Nejat G, Pons J, Patterson K. Exoskeleton use in post-stroke gait rehabilitation: a qualitative study of the perspectives of persons post-stroke and physiotherapists. J Neuroeng Rehabil. 2020 Sep 10;17(1):123. doi: 10.1186/s12984-020-00750-x. PMID 32912215
- Vieira de Melo RF, Utiyama DMO, Goncalves da Mota C, Ribeiro MF, Carvalho PF, de Castro Leite E, Cichon F, Sugawara AT, Battistella LR. Recovery of appetite after using a direct weight-bearing exoskeleton for walking: a case report. Spinal Cord Ser Cases. 2025 Mar 12;11(1):5. doi: 10.1038/s41394-025-00700-6. PMID 40075092
- Read E, Woolsey C, McGibbon CA, O'Connell C. Physiotherapists' Experiences Using the Ekso Bionic Exoskeleton with Patients in a Neurological Rehabilitation Hospital: A Qualitative Study. Rehabil Res Pract. 2020 Jan 8;2020:2939573. doi: 10.1155/2020/2939573. eCollection 2020. PMID 32395347
- Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009 Aug;8(8):741-54. doi: 10.1016/S1474-4422(09)70150-4. PMID 19608100