Paraplegia and TetraplegiaNCT07767955
Healthcare Professionals' Satisfaction With Various Exoskeleton Models
An observational study of Paraplegia and Tetraplegia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Paraplegia and Tetraplegia
- What is being tested?
- Exoskeleton
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2024to 1 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Not being a rehabilitation specialist, having less than six months of experience with the device
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05.403-010
About this study
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.
- Conditions
- Paraplegia and Tetraplegia
- Being tested
- Exoskeleton
- Keywords
- Exoskeleton, Rehabilitation, Medicine; Physiatry, Paraplegias, User satisfaction
- Medical subject headings
- Paraplegia, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExoskeletonDevice
Also called LokomatPro FreeD module
Grounded exoskeleton
ExoskeletonDevice
Also called Atalante X
Autonomous wearable exoskeleton
ExoskeletonDevice
Wearable device that requires clutches
What is being measured
The primary outcome is the main question the study is designed to answer.
User satisfaction
A System Usability Scale questionnaire was applied in order to asses a quantitative score for each device
Measured: When the participant completed 6 months of experience with the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Oct 2024
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Paraplegia and TetraplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, André Tadeu Sugawara, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767955
- Sponsor's protocol ID
- 69679423.3.0000.0068
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
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/>
Bangor A, Kortum P, Miller J. Determining what individual SUS scores mean: adding an adjective rating scale. J Usability Stud. 2009;4:114-23.
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.
PubMed 30569950Shapkova 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.
PubMed 32528238Elmas 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.
PubMed 38241771Kerdraon 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.
PubMed 34349101Lee 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.
PubMed 33950915Zhang 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.
PubMed 35493806Mortenson 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.
PubMed 32649239Mertz 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.
PubMed 22850839Louie 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.
PubMed 27278136Lajeunesse 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.
PubMed 26340538Vaughan-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.
PubMed 32912215Vieira 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.
PubMed 40075092
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthcare Professionals' Satisfaction With Various Exoskeleton Models
- ClinicalTrials.gov ID
- NCT07767955
- Acronym / sponsor ID
- 69679423.3.0000.0068
- Conditions
- Paraplegia and Tetraplegia
- Keywords
- Exoskeleton, Rehabilitation, Medicine; Physiatry, Paraplegias, User satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Not being a rehabilitation specialist, having less than six months of experience with the device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExoskeletonAlso: LokomatPro FreeD moduleGrounded exoskeleton | Device | – |
| ExoskeletonAlso: Atalante XAutonomous wearable exoskeleton | Device | – |
| ExoskeletonWearable device that requires clutches | Device | – |
Primary outcome
User satisfaction
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- BackgroundR Core Team (2025). _R: A Language and Environment for Statistical Computing_. R Foundation for Statistical Computing, Vienna, Austria. <https://www.R-project.org/>
- BackgroundBangor A, Kortum P, Miller J. Determining what individual SUS scores mean: adding an adjective rating scale. J Usability Stud. 2009;4:114-23.
- BackgroundBrooke J. SUS: a quick and dirty usability scale. Usability Eval Ind. 1996;189:4-7.
- Background: PubMed 30569950Padrini-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.
- Background: PubMed 32528238Shapkova 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.
- Background: PubMed 38241771Elmas 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.
- Background: PubMed 34349101Kerdraon 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.
- Background: PubMed 33950915Lee 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.
- Background: PubMed 35493806Zhang 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.
- Background: PubMed 32649239Mortenson 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.
- Background: PubMed 22850839Mertz 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.
- Background: PubMed 27278136Louie 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.
Related trials for Paraplegia and Tetraplegia
Recruiting
A Neuroprosthesis for Seated Posture and Balance
Spinal Cord Injury, Paralysis
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Not yet recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain
RecruitingPhase 1/2
Psilocybin to Treat Depression in Spinal Cord Injury
Spinal Cord Injury, Depression - Major Depressive Disorder
Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paraplegia and Tetraplegia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User satisfaction (time frame: When the participant completed 6 months of experience with the device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07767955, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.