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Completed
NCT07757737
Impact of Exoskeleton Use on Perceived Effort and Pain During Resident Handling in Nursing Home Care Staff
Conditions: Musculoskeletal Diseases, Occupational Diseases, Low Back Pain, Occupational Health
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 35
Sponsor: LNA SANTE
Location: Villa Océane Belz
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.
Eligibility Criteria
Inclusion Criteria:
* Currently employed at the study site for at least 1 month, with a completed probationary period
* Working in an open care unit (unité ouverte) of a LNA Santé nursing home (EHPAD), either day or night shifts
* Regularly performing care tasks for residents in lying position (decubitus), including bed baths and diaper changes
* Able to read and write French
* Having provided written informed consent to participate in the study
Exclusion Criteria:
* Pre-existing diagnosed back condition or rheumatological disease (such as rheumatoid arthritis or polymyalgia rheumatica) or shoulder condition (shoulder prosthesis or rotator cuff tear) that would prevent safe exoskeleton use
* Any other health condition preventing exoskeleton wear
* Employment contract shorter than the study duration
* Unable to give written informed consent
* Person protected under French law (pregnant, breastfeeding or recently delivered woman; minor; person under legal protection; person deprived of liberty - as per Articles L1121-5 to L1121-8 of the French Public Health Code)
* Not affiliated with a French social security scheme
Source: ClinicalTrials.gov (NCT07757737). StuddyBuddy aggregates publicly available trial information.