Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT06995469
Status:
COMPLETED
Last Update Posted:
2025-06-04
First Post:
2025-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of a Passive Lower Limb Exoskeleton in Reducing Plantar Pressure and Injuries From Prolonged Standing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2025-05-06', 'studyFirstSubmitQcDate': '2025-05-26', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'Immediately after task performance in each condition (with and without exoskeleton) - approximately same workday or within 1-2 days', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Change in Postural Stability With vs. Without Passive Exoskeleton', 'timeFrame': 'Immediately after task performance in each condition (with and without exoskeleton)', 'description': '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.'}, {'measure': 'Perceived Fatigue After Work Tasks With vs. Without Exoskeleton', 'timeFrame': 'Immediately after task completion in each condition - within same workday', 'description': '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.'}, {'measure': 'User Comfort and Usability of the Passive Exoskeleton', 'timeFrame': 'After using the exoskeleton during a full work session - within 1 day', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Passive exoskeleton', 'Lower limbs', 'Prolonged standing', 'Plantar pressure', 'Occupational ergonomics'], 'conditions': ['Health-Related Behavior']}, 'referencesModule': {'references': [{'pmid': '34892218', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32988243', 'type': 'BACKGROUND', 'citation': 'Steinhilber 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.'}, {'pmid': '34068352', 'type': 'BACKGROUND', 'citation': 'Kong 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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nObjective 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.\n\nMethodology Study design: Quasi-experimental with repeated measures (participants act as their own control).\n\nParticipants: 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.\n\nDevice: Chairless Chair® 2.0 by Noonee Germany GmbH-a passive, non-powered exoskeleton enabling users to alternate between standing and semi-sitting positions.\n\nTools and Measurements:\n\nPodoprint S4 pressure platform to measure:\n\nPlantar pressure distribution (forefoot, midfoot, heel)\n\nBody sway and stability (center of pressure displacement)\n\nCR10 Borg scale for fatigue\n\nQUEST 2.0 for usability and satisfaction\n\nData Analysis:\n\nQuantitative analysis using SPSS and JASP\n\nPaired t-tests or Wilcoxon tests for comparisons\n\nSpearman correlations and Chi-square tests for categorical relationships\n\nStatistical significance set at p \\< 0.05\n\nKey Variables Dependent: Plantar pressure (kPa), body sway (cm²), postural stability (mm/s), fatigue perception, comfort.\n\nIndependent: Use of exoskeleton, age, gender, BMI, type of footwear, reported discomfort.\n\nEthical and Legal Framework Ethical approval granted by the Comité de Ética de la Universidad Católica de Valencia (CEI).\n\nCompliance with LOPDGDD, GDPR, and Declaration of Helsinki.\n\nInformed consent obtained; anonymity and data protection were strictly maintained.\n\nExpected Outcomes Reduction in peak plantar pressure and postural sway when using the exoskeleton.\n\nImprovement in stability and fatigue levels.\n\nEnhanced user comfort and satisfaction, making the device a feasible ergonomic intervention.\n\nSignificance 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults aged 18 to 60 years\n\nCurrently employed in jobs requiring prolonged standing (≥4 hours/day)\n\nMinimum 6 months of work experience in such standing-intensive roles\n\nPhysically capable of performing normal job tasks\n\nAble and willing to provide informed consent\n\nExclusion Criteria:\n\nDiagnosis of musculoskeletal or circulatory conditions (e.g., plantar fasciitis, varicose veins, chronic venous insufficiency)\n\nCurrent use of orthopedic or ergonomic devices, such as foot orthoses\n\nUncontrolled medical conditions that may pose a risk (e.g., uncontrolled hypertension)\n\nPregnancy\n\nInability to understand or comply with study procedures'}, 'identificationModule': {'nctId': 'NCT06995469', 'acronym': 'PELLEPSI', 'briefTitle': 'Efficacy of a Passive Lower Limb Exoskeleton in Reducing Plantar Pressure and Injuries From Prolonged Standing', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Universidad Católica de Valencia San Vicente Mártir'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'UCV/2024-2025/030'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exoskeleton', 'description': '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.\n\nEach 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.', 'interventionNames': ['Procedure: Chairless Chair® 2.0 Passive Lower-Limb Exoskeleton']}], 'interventions': [{'name': 'Chairless Chair® 2.0 Passive Lower-Limb Exoskeleton', 'type': 'PROCEDURE', 'description': '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.\n\nThe 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.\n\nObjective data were collected using a plantar pressure platform (Podoprint S4, Namrol) to measure:\n\nPlantar pressure distribution\n\nPostural stability\n\nBody sway', 'armGroupLabels': ['Exoskeleton']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46001', 'city': 'Valencia', 'state': 'València', 'country': 'Spain', 'facility': 'Clinicas UCV', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'JAVIER FERRER TORREGROSA, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNIVERSIDAD CATOLICA DE VALENCIA'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'All published results and associated materials will be accessible indefinitely through institutional repositories or journal archives', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Universidad Católica de Valencia San Vicente Mártir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'HEAD OF PODIATRY DEPARTMENT', 'investigatorFullName': 'Javier Ferrer Torregrosa', 'investigatorAffiliation': 'Fundación Universidad Católica de Valencia San Vicente Mártir'}}}}