Efficacy of a Passive Lower Limb Exoskeleton in Reducing Plantar Pressure and Injuries From Prolonged Standing

NCT06995469 | Completed

• 1 other identifier: UCV/2024-2025/030
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Health-Related Behavior

Keywords

Passive exoskeleton; Lower limbs; Prolonged standing; Plantar pressure; Occupational ergonomics

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Immediately after task performance in each condition (with and without exoskeleton)

• Perceived Fatigue After Work Tasks With vs. Without Exoskeleton

  Immediately after task completion in each condition - within same workday

• User Comfort and Usability of the Passive Exoskeleton

  After using the exoskeleton during a full work session - within 1 day

Study Arms (1)

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.

Procedure: Chairless Chair® 2.0 Passive Lower-Limb Exoskeleton

Interventions

Chairless Chair® 2.0 Passive Lower-Limb Exoskeleton PROCEDURE

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

Exoskeleton

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (1)

Clinicas UCV

Valencia, València, 46001, Spain

Location

Related Publications (3)

• 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: 34892218 BACKGROUND

• 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: 32988243 BACKGROUND

• 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.

  PMID: 34068352 BACKGROUND

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• JAVIER FERRER TORREGROSA, Dr.

  UNIVERSIDAD CATOLICA DE VALENCIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HEAD OF PODIATRY DEPARTMENT

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 29, 2025
• Study Start: March 1, 2025
• Primary Completion: May 26, 2025
• Study Completion: May 26, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: All published results and associated materials will be accessible indefinitely through institutional repositories or journal archives
• Access Criteria: Open access

Locations

ES (1)