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Impact of Exoskeleton Use on Perceived Effort and Pain During Resident Handling in Nursing Home Care Staff

NCT07757737 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2026-08-11

No results posted yet for this study

Summary

The EXO 2 study assessed whether daily use of an exoskeleton - a wearable mechanical support device - could reduce physical effort and pain in nursing home care staff who regularly perform resident handling tasks such as bed baths and diaper changes.

Care staff in nursing homes (EHPADs) are among the most affected workers by musculoskeletal disorders (MSDs), which are the leading cause of occupational illness and sick leave in the French healthcare sector. Handling of residents in lying positions (decubitus), such as turning, washing, or changing residents in bed, is one of the most physically demanding tasks and a major source of lower and upper back strain.

The HAPO Version 4 exoskeleton is a wearable device worn around the torso that provides mechanical support to the upper body and back during forward-bending tasks. This study is part of a research program that progressively evaluated and improved the HAPO exoskeleton through four earlier phases with LNA Santé care staff.

The main questions this study aimed to answer were:

Does wearing the HAPO exoskeleton daily reduce the perceived effort (physical fatigue) felt in the upper body during resident handling? Does the exoskeleton reduce upper body pain (neck, shoulders, arms, back, hips) over time? How well do care staff integrate the exoskeleton into their daily work routine? Does exoskeleton use reduce workplace accidents and sick leave related to handling?

What participants did:

First 2 weeks (baseline): worked normally without the exoskeleton, completing a daily logbook to record pain and workload Following 11 weeks (intervention): wore the exoskeleton daily during all bed baths and resident changes in decubitus, continuing the daily logbook Completed weekly assessments of perceived effort and satisfaction with the device Were assessed at the end of the study (Day 91) with a final evaluation

The study took place across 5 LNA Santé nursing homes in France and included 35 volunteer care staff members.

Conditions

  • Musculoskeletal Diseases
  • Occupational Diseases
  • Low Back Pain
  • Occupational Health

Interventions

DEVICE

Passive back-assist exoskeleton (HAPO Version 4)

The HAPO Version 4 is a passive (non-motorized), CE-marked, wearable exoskeleton worn around the torso, designed to provide mechanical support to the dorsal and lumbar spine during forward-bending tasks. It is individually fitted to each participant's morphology. Care staff wore the device daily during all bed baths and diaper changes performed with residents in decubitus position, throughout their working shifts (day and night), from Day 15 to Day 91 (11 weeks). Usage was voluntary on a daily basis. Exoskeleton use did not replace existing patient-handling equipment. The device was supplied and maintained by Ergo Santé (France

Sponsors & Collaborators

  • LNA SANTE

    lead OTHER

Principal Investigators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-23
Primary Completion
2025-07-01
Completion
2025-07-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757737 on ClinicalTrials.gov