NCT07767955

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2026

Completed
Last Updated

August 17, 2026

Status Verified

August 1, 2026

Enrollment Period

1.1 years

First QC Date

August 11, 2026

Last Update Submit

August 11, 2026

Conditions

Keywords

ExoskeletonRehabilitationMedicine; PhysiatryParaplegiasUser satisfaction

Outcome Measures

Primary Outcomes (1)

  • User satisfaction

    A System Usability Scale questionnaire was applied in order to asses a quantitative score for each device

    When the participant completed 6 months of experience with the device

Interventions

Grounded exoskeleton

Also known as: LokomatPro FreeD module

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • Not being a rehabilitation specialist, having less than six months of experience with the device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05.403-010, Brazil

Location

Related Publications (17)

  • R Core Team (2025). _R: A Language and Environment for Statistical Computing_. R Foundation for Statistical Computing, Vienna, Austria. <https://www.R-project.org/>

    BACKGROUND
  • Bangor A, Kortum P, Miller J. Determining what individual SUS scores mean: adding an adjective rating scale. J Usability Stud. 2009;4:114-23.

    BACKGROUND
  • Brooke J. SUS: a quick and dirty usability scale. Usability Eval Ind. 1996;189:4-7.

    BACKGROUND
  • 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: 30569950BACKGROUND
  • 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: 32528238BACKGROUND
  • 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: 38241771BACKGROUND
  • 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: 34349101BACKGROUND
  • Lee HY, Park JH, Kim TW. Comparisons between Locomat and Walkbot robotic gait training regarding balance and lower extremity function among non-ambulatory chronic acquired brain injury survivors. Medicine (Baltimore). 2021 May 7;100(18):e25125. doi: 10.1097/MD.0000000000025125.

    PMID: 33950915BACKGROUND
  • 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: 35493806BACKGROUND
  • 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: 32649239BACKGROUND
  • 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: 22850839BACKGROUND
  • 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: 27278136BACKGROUND
  • 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: 26340538BACKGROUND
  • 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: 32912215BACKGROUND
  • 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: 40075092BACKGROUND
  • 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: 32395347BACKGROUND
  • 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: 19608100BACKGROUND

MeSH Terms

Conditions

ParaplegiaQuadriplegia

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 11, 2026

First Posted

August 17, 2026

Study Start

October 1, 2024

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

August 17, 2026

Record last verified: 2026-08

Locations