Health-Related BehaviorPELLEPSINCT06995469
Efficacy of a Passive Lower Limb Exoskeleton in Reducing Plantar Pressure and Injuries From Prolonged Standing
An observational study of Health-Related Behavior, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
Trial summary
This quasi-experimental study evaluates the effectiveness of a passive lower-limb exoskeleton (Chairless Chair® 2.0) in redistributing plantar pressure and reducing injuries caused by prolonged standing in workplace settings. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Health-Related Behavior
- What is being tested?
- Chairless Chair® 2.0 Passive Lower-Limb Exoskeleton
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2025to 26 May 2025
- How long will I take part?
- 1 Day
- 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 18 to 60 years
- All sexes
- Adult
Study population: The study population consists of adults aged 18-65 who work in roles requiring ≥4 hours of standing daily, with at least 6 months of continuous experience. Participants were selected through purposive sampling based on specific inclusion/exclusion criteria. Individuals with diagnosed musculoskeletal or circulatory disorders or those already using orthopedic/ergonomic devices were excluded. This group reflects a real-world ergonomic risk population, suitable for assessing the preventive efficacy of a passive lower limb exoskeleton in the workplace.
Who may be able to join
- Adults aged 18 to 60 years
- Currently employed in jobs requiring prolonged standing (≥4 hours/day)
- Minimum 6 months of work experience in such standing-intensive roles
- Physically capable of performing normal job tasks
- Able and willing to provide informed consent
Who cannot join
- Diagnosis of musculoskeletal or circulatory conditions (e.g., plantar fasciitis, varicose veins, chronic venous insufficiency)
- Current use of orthopedic or ergonomic devices, such as foot orthoses
- Uncontrolled medical conditions that may pose a risk (e.g., uncontrolled hypertension)
- Pregnancy
- Inability to understand or comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Passive Lower Limb Exoskeleton on Plantar Pressure Distribution to Reduce on Plantar Pressure Distribution to Reduce Prolonged Standing Injuries: Prolonged Standing Injuries
This quasi-experimental study evaluates the effectiveness of a passive lower-limb exoskeleton (Chairless Chair® 2.0) in redistributing plantar pressure and reducing injuries caused by prolonged standing in workplace settings. Conducted on 25 participants, the research measured plantar pressure, body sway, and postural stability with and without the exoskeleton using a pressure platform. Additionally, user fatigue and satisfaction were assessed through validated questionnaires (Borg CR10, QUEST 2.0). The results aim to determine the device's preventive potential regarding musculoskeletal and circulatory issues, contributing to improved ergonomic health and work performance.
Read the detailed description
Prolonged standing is a common requirement in various professional sectors (e.g., healthcare, industry), and is associated with increased risks of musculoskeletal and circulatory disorders, especially in the lower limbs. Conditions such as plantar fasciitis, chronic venous insufficiency, and pressure ulcers are prevalent. These affect worker health, comfort, and productivity, and impose economic burdens on employers and healthcare systems.
Objective To evaluate the effectiveness of a passive exoskeleton for the lower limbs (Chairless Chair® 2.0) in redistributing plantar pressure and reducing musculoskeletal injuries associated with prolonged standing. The study also investigates the device's influence on postural stability, perceived fatigue, and user comfort.
Methodology Study design: Quasi-experimental with repeated measures (participants act as their own control).
Participants: 25 adult workers (aged 18-60), with ≥6 months of exposure to prolonged standing at work. Exclusion criteria included pre-existing musculoskeletal or circulatory disorders and use of orthopedic devices.
Device: Chairless Chair® 2.0 by Noonee Germany GmbH-a passive, non-powered exoskeleton enabling users to alternate between standing and semi-sitting positions.
Tools and Measurements:
Podoprint S4 pressure platform to measure:
Plantar pressure distribution (forefoot, midfoot, heel)
Body sway and stability (center of pressure displacement)
CR10 Borg scale for fatigue
QUEST 2.0 for usability and satisfaction
Data Analysis:
Quantitative analysis using SPSS and JASP
Paired t-tests or Wilcoxon tests for comparisons
Spearman correlations and Chi-square tests for categorical relationships
Statistical significance set at p < 0.05
Key Variables Dependent: Plantar pressure (kPa), body sway (cm²), postural stability (mm/s), fatigue perception, comfort.
Independent: Use of exoskeleton, age, gender, BMI, type of footwear, reported discomfort.
Ethical and Legal Framework Ethical approval granted by the Comité de Ética de la Universidad Católica de Valencia (CEI).
Compliance with LOPDGDD, GDPR, and Declaration of Helsinki.
Informed consent obtained; anonymity and data protection were strictly maintained.
Expected Outcomes Reduction in peak plantar pressure and postural sway when using the exoskeleton.
Improvement in stability and fatigue levels.
Enhanced user comfort and satisfaction, making the device a feasible ergonomic intervention.
Significance This study seeks to fill a gap in scientific literature regarding the biomechanical benefits of passive lower-limb exoskeletons in real work environments, providing evidence for their role in injury prevention, ergonomic improvement, and worker well-being.
- Conditions
- Health-Related Behavior
- Being tested
- Chairless Chair® 2.0 Passive Lower-Limb Exoskeleton
- Keywords
- Passive exoskeleton, Lower limbs, Prolonged standing, Plantar pressure, Occupational ergonomics
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chairless Chair® 2.0 Passive Lower-Limb ExoskeletonProcedure or surgery
Participants used a passive lower-limb exoskeleton (Chairless Chair® 2.0) during their regular work tasks involving prolonged standing. The device enables a semi-seated posture without the need for external power, aiming to reduce lower limb strain.
The intervention involved each participant performing their typical standing tasks once with the exoskeleton and once without it, in a within-subject repeated-measures design. Each participant served as their own control.
Objective data were collected using a plantar pressure platform (Podoprint S4, Namrol) to measure:
Plantar pressure distribution
Postural stability
Body sway
| Study group | Role | What they receive |
|---|---|---|
| Exoskeleton | This single-group cohort consists of participants assessed under two conditions: (1) performing prolonged standing tasks with the use of a passive lower-limb exoskeleton (Chairless Chair® 2.0) and (2) performing the same tasks without the exoskeleton.
Each participant serves as their own control in a within-subject, repeated-measures design to evaluate changes in plantar pressure distribution, postural stability, perceived fatigue, and device usability. Receives: Procedure: Chairless Chair® 2.0 Passive Lower-Limb Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plantar Pressure Distribution With vs. Without Passive Exoskeleton Use Change in Plantar Pressure Distribution With vs. Without Passive Exoskeleton Use Change in Plantar Pressure Distribution With vs. Without Passive Exoskeleton Use
Mean plantar pressure values (in kilopascals, kPa) will be measured in key foot regions (heel, midfoot, forefoot) using the Podoprint S4 platform. Data will be collected under two conditions: while performing tasks with the Chairless Chair® 2.0 and without it. The comparison will assess the exoskeleton's effectiveness in redistributing plantar loads during prolonged standing.
Measured: Immediately after task performance in each condition (with and without exoskeleton) - approximately same workday or within 1-2 days
Secondary outcomes (3)
Change in Postural Stability With vs. Without Passive Exoskeleton
Postural stability and center of pressure (COP) displacement (in cm² and mm/s) will be measured during static standing using the Podoprint S4 pressure platform. The goal is to evaluate whether the exoskeleton improves balance and reduces body sway during prolonged standing tasks.
Measured: Immediately after task performance in each condition (with and without exoskeleton)
Perceived Fatigue After Work Tasks With vs. Without Exoskeleton
Fatigue in the lower extremities will be assessed using the Borg Scale CR10, a validated ordinal questionnaire ranging from 0 (no exertion) to 10 (maximum exertion). A higher score indicates greater perceived fatigue. Participants will report their perception of exertion immediately after completing the tasks, both with and without the exoskeleton.
Measured: Immediately after task completion in each condition - within same workday
User Comfort and Usability of the Passive Exoskeleton
Participants will complete the QUEST 2.0 (Quebec User Satisfaction Evaluation of Assistive Technology) questionnaire, which includes scores on a scale from 1 (very dissatisfied) to 5 (very satisfied). Higher scores reflect greater satisfaction and positive perception of the comfort, usability and acceptability of the device. The results will allow assessment of the practical acceptability of the exoskeleton in real work environments.
Measured: After using the exoskeleton during a full work session - within 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Mar 2025
- Primary completion26 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health-Related BehaviorStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente Mártir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Ferrer Torregrosa, Fundación Universidad Católica de Valencia San Vicente Mártir
- Investigators
- JAVIER FERRER TORREGROSA, Dr., Principal investigator, UNIVERSIDAD CATOLICA DE VALENCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995469
- Sponsor's protocol ID
- UCV/2024-2025/030
- Acronym
- PELLEPSI
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of this study will be made publicly available through publication in a peer-reviewed scientific journal and presentation at academic conferences. A summary of the findings will also be provided to participants upon request. In addition, anonymized datasets and key outcome summaries may be shared for academic and research purposes.
Publications
Liu L, Wei W, Zheng K, Diao Y, Wang Z, Li G, Zhao G. Design of an Unpowered Ankle-Foot Exoskeleton Used for Walking Assistance. Annu Int Conf IEEE Eng Med Biol Soc. 2021 Nov;2021:4501-4504. doi: 10.1109/EMBC46164.2021.9630707.
PubMed 34892218Steinhilber B, Seibt R, Rieger MA, Luger T. Postural Control When Using an Industrial Lower Limb Exoskeleton: Impact of Reaching for a Working Tool and External Perturbation. Hum Factors. 2022 Jun;64(4):635-648. doi: 10.1177/0018720820957466. Epub 2020 Sep 28.
PubMed 32988243Kong YK, Park CW, Cho MU, Kim SY, Kim MJ, Hyun DJ, Bae K, Choi JK, Ko SM, Choi KH. Guidelines for Working Heights of the Lower-Limb Exoskeleton (CEX) Based on Ergonomic Evaluations. Int J Environ Res Public Health. 2021 May 13;18(10):5199. doi: 10.3390/ijerph18105199.
PubMed 34068352
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Passive Lower Limb Exoskeleton on Plantar Pressure Distribution to Reduce on Plantar Pressure Distribution to Reduce Prolonged Standing Injuries: Prolonged Standing Injuries
- ClinicalTrials.gov ID
- NCT06995469
- Acronym / sponsor ID
- PELLEPSI / UCV/2024-2025/030
- Conditions
- Health-Related Behavior
- Keywords
- Passive exoskeleton, Lower limbs, Prolonged standing, Plantar pressure, Occupational ergonomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente MártirUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 29 May 2025 (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.
This quasi-experimental study evaluates the effectiveness of a passive lower-limb exoskeleton (Chairless Chair® 2.0) in redistributing plantar pressure and reducing injuries caused by prolonged standing in workplace settings. Conducted on 25 participants, the research measured plantar pressure, body sway, and postural stability with and without the exoskeleton using a pressure platform. Additionally, user fatigue and satisfaction were assessed through validated questionnaires (Borg CR10, QUEST 2.0). The results aim to determine the device's preventive potential regarding musculoskeletal and circulatory issues, contributing to improved ergonomic health and work performance.
Detailed description
Prolonged standing is a common requirement in various professional sectors (e.g., healthcare, industry), and is associated with increased risks of musculoskeletal and circulatory disorders, especially in the lower limbs. Conditions such as plantar fasciitis, chronic venous insufficiency, and pressure ulcers are prevalent. These affect worker health, comfort, and productivity, and impose economic burdens on employers and healthcare systems.
Objective To evaluate the effectiveness of a passive exoskeleton for the lower limbs (Chairless Chair® 2.0) in redistributing plantar pressure and reducing musculoskeletal injuries associated with prolonged standing. The study also investigates the device's influence on postural stability, perceived fatigue, and user comfort.
Methodology Study design: Quasi-experimental with repeated measures (participants act as their own control).
Participants: 25 adult workers (aged 18-60), with ≥6 months of exposure to prolonged standing at work. Exclusion criteria included pre-existing musculoskeletal or circulatory disorders and use of orthopedic devices.
Device: Chairless Chair® 2.0 by Noonee Germany GmbH-a passive, non-powered exoskeleton enabling users to alternate between standing and semi-sitting positions.
Tools and Measurements:
Podoprint S4 pressure platform to measure:
Plantar pressure distribution (forefoot, midfoot, heel)
Body sway and stability (center of pressure displacement)
CR10 Borg scale for fatigue
QUEST 2.0 for usability and satisfaction
Data Analysis:
Quantitative analysis using SPSS and JASP
Paired t-tests or Wilcoxon tests for comparisons
Spearman correlations and Chi-square tests for categorical relationships
Statistical significance set at p < 0.05
Key Variables Dependent: Plantar pressure (kPa), body sway (cm²), postural stability (mm/s), fatigue perception, comfort.
Independent: Use of exoskeleton, age, gender, BMI, type of footwear, reported discomfort.
Ethical and Legal Framework Ethical approval granted by the Comité de Ética de la Universidad Católica de Valencia (CEI).
Compliance with LOPDGDD, GDPR, and Declaration of Helsinki.
Informed consent obtained; anonymity and data protection were strictly maintained.
Expected Outcomes Reduction in peak plantar pressure and postural sway when using the exoskeleton.
Improvement in stability and fatigue levels.
Enhanced user comfort and satisfaction, making the device a feasible ergonomic intervention.
Significance This study seeks to fill a gap in scientific literature regarding the biomechanical benefits of passive lower-limb exoskeletons in real work environments, providing evidence for their role in injury prevention, ergonomic improvement, and worker well-being.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton | – | Procedure: Chairless Chair® 2.0 Passive Lower-Limb ExoskeletonThis single-group cohort consists of participants assessed under two conditions: (1) performing prolonged standing tasks with the use of a passive lower-limb exoskeleton (Chairless Chair® 2.0) and (2) performing the same tasks without the exoskeleton. Each participant serves as their own control in a within-subject, repeated-measures design to evaluate changes in plantar pressure distribution, postural stability, perceived fatigue, and device usability. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- The study population consists of adults aged 18-65 who work in roles requiring ≥4 hours of standing daily, with at least 6 months of continuous experience. Participants were selected through purposive sampling based on specific inclusion/exclusion criteria. Individuals with diagnosed musculoskeletal or circulatory disorders or those already using orthopedic/ergonomic devices were excluded. This group reflects a real-world ergonomic risk population, suitable for assessing the preventive efficacy of a passive lower limb exoskeleton in the workplace.
Key inclusion criteria (5 listed)
- Adults aged 18 to 60 years
- Currently employed in jobs requiring prolonged standing (≥4 hours/day)
- Minimum 6 months of work experience in such standing-intensive roles
- Physically capable of performing normal job tasks
- Able and willing to provide informed consent
Key exclusion criteria (5 listed)
- Diagnosis of musculoskeletal or circulatory conditions (e.g., plantar fasciitis, varicose veins, chronic venous insufficiency)
- Current use of orthopedic or ergonomic devices, such as foot orthoses
- Uncontrolled medical conditions that may pose a risk (e.g., uncontrolled hypertension)
- Pregnancy
- Inability to understand or comply with study procedures
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 |
|---|---|---|
| Chairless Chair® 2.0 Passive Lower-Limb ExoskeletonParticipants used a passive lower-limb exoskeleton (Chairless Chair® 2.0) during their regular work tasks involving prolonged standing. The device enables a semi-seated posture without the need for external power, aiming to reduce lower limb strain. The intervention involved each participant performing their typical standing tasks once with the exoskeleton and once without it, in a within-subject repeated-measures design. Each participant served as their own control. Objective data were collected using a plantar pressure platform (Podoprint S4, Namrol) to measure: Plantar pressure distribution Postural stability Body sway | Procedure or surgery | Exoskeleton |
Primary outcome
Change in Plantar Pressure Distribution With vs. Without Passive Exoskeleton Use Change in Plantar Pressure Distribution With vs. Without Passive Exoskeleton Use Change in Plantar Pressure Distribution With vs. Without Passive Exoskeleton Use
Time frame: Immediately after task performance in each condition (with and without exoskeleton) - approximately same workday or within 1-2 days
Mean plantar pressure values (in kilopascals, kPa) will be measured in key foot regions (heel, midfoot, forefoot) using the Podoprint S4 platform. Data will be collected under two conditions: while performing tasks with the Chairless Chair® 2.0 and without it. The comparison will assess the exoskeleton's effectiveness in redistributing plantar loads during prolonged standing.
3 secondary outcomes
Change in Postural Stability With vs. Without Passive Exoskeleton
Time frame: Immediately after task performance in each condition (with and without exoskeleton)
Perceived Fatigue After Work Tasks With vs. Without Exoskeleton
Time frame: Immediately after task completion in each condition - within same workday
User Comfort and Usability of the Passive Exoskeleton
Time frame: After using the exoskeleton during a full work session - within 1 day
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 4 Jun 2025.
- Background: PubMed 34892218Liu L, Wei W, Zheng K, Diao Y, Wang Z, Li G, Zhao G. Design of an Unpowered Ankle-Foot Exoskeleton Used for Walking Assistance. Annu Int Conf IEEE Eng Med Biol Soc. 2021 Nov;2021:4501-4504. doi: 10.1109/EMBC46164.2021.9630707.
- Background: PubMed 32988243Steinhilber B, Seibt R, Rieger MA, Luger T. Postural Control When Using an Industrial Lower Limb Exoskeleton: Impact of Reaching for a Working Tool and External Perturbation. Hum Factors. 2022 Jun;64(4):635-648. doi: 10.1177/0018720820957466. Epub 2020 Sep 28.
- Background: PubMed 34068352Kong YK, Park CW, Cho MU, Kim SY, Kim MJ, Hyun DJ, Bae K, Choi JK, Ko SM, Choi KH. Guidelines for Working Heights of the Lower-Limb Exoskeleton (CEX) Based on Ergonomic Evaluations. Int J Environ Res Public Health. 2021 May 13;18(10):5199. doi: 10.3390/ijerph18105199.
- Individual participant dataSharing planned: Yes. The results of this study will be made publicly available through publication in a peer-reviewed scientific journal and presentation at academic conferences. A summary of the findings will also be provided to participants upon request. In addition, anonymized datasets and key outcome summaries may be shared for academic and research purposes.
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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.
JAVIER FERRER TORREGROSA, Dr. principal investigator
UNIVERSIDAD CATOLICA DE VALENCIA
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 Health-Related Behavior, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
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 5 inclusion and 5 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 4 Jun 2025. 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 Spain. 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?
Change in Plantar Pressure Distribution With vs. Without Passive Exoskeleton Use Change in Plantar Pressure Distribution With vs. Without Passive Exoskeleton Use Change in Plantar Pressure Distribution With vs. Without Passive Exoskeleton Use (time frame: Immediately after task performance in each condition (with and without exoskeleton) - approximately same workday or within 1-2 days). 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 NCT06995469, which also lists 3 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 4 Jun 2025.