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

NCT07757737 | Completed

• 1 other identifier: Exo 2
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Exoskeleton; Musculoskeletal disorders; Occupational health; Nursing home; Care staff; Patient handling; Work-related pain; Assistive technology; Prevention

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Upper Body Perceived Exertion During Resident Handling as Assessed by the Borg CR10 Scale at Day 28, Day 35, Day 63, and Day 91

  The Borg CR10 (Category Ratio 10) is a validated ratio scale measuring subjective perceived exertion during physical tasks. In this study, it is applied to upper body effort (neck, shoulders, upper arms, back, hips/waist) experienced during resident handling in decubitus position. Completed weekly by participants. Score ranges from 0 (nothing at all) to 10 (maximal exertion); higher score = greater perceived effort. Baseline is the mean of scores at Day 7 and Day 14 (pre-exoskeleton phase). Change from baseline = weekly score minus mean baseline score.

  Baseline (Day 7 and Day 14, without exoskeleton) and weekly from Day 15 to Day 91; key analysis time points: Day 28, Day 35, Day 63, and Day 91

Secondary Outcomes (9)

• Change from Baseline in Daily Upper Body Pain Intensity as Assessed by the Visual Analog Scale (VAS) at Day 21, Day 28, Day 70, and Day 91

  Daily from Day 0 to Day 91; key analysis time points: Day 21, Day 28, Day 70, and Day 91

• Rate of Exoskeleton Use (Full, Partial, or Refused) During the Intervention Period

  Daily from Day 15 to Day 91

• Change in Participant Satisfaction with the HAPO V4 Exoskeleton Over the Intervention Period

  Weekly from Day 15 to Day 91

• Evolution of Weekly Number of Resident Handling Tasks in Decubitus During the Study Period

  Weekly from Day 7 to Day 91

• Change in Restricted Absenteeism Rate in Participating Units Before, During, and After the Exoskeleton Intervention

  Retrospective data from Month -12 to Month -1 and prospective data from Month 1 to Month 6, collected at end of study

Study Arms (1)

Care Staff Exoskeleton Cohort

Volunteer nursing home care staff (nursing assistants, registered nurses, personal care assistants) from 5 LNA Santé EHPADs, who regularly perform resident handling tasks in decubitus position (bed baths, diaper changes), enrolled during a 2-week baseline phase without exoskeleton followed by 11 weeks of daily HAPO V4 exoskeleton use. The cohort includes both asymptomatic staff (primary prevention) and staff with prior upper body pain history (secondary prevention)

Device: Passive back-assist exoskeleton (HAPO Version 4)

Interventions

Passive back-assist exoskeleton (HAPO Version 4) DEVICE

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

Also known as: HAPO CS V4; HAPO exoskeleton; harness exoskeleton

Care Staff Exoskeleton Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteer care staff (nursing assistants, registered nurses, personal care assistants, psychomotor therapists) from five LNA Santé nursing homes in France who regularly perform resident handling tasks in decubitus position.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LNA SANTE: lead

Study Sites (5)

Villa Océane

Belz, 56550, France

Location

Résidence Marconi

Chatou, 78400, France

Location

Les Jardins d'Olonne

Les Sables-d'Olonne, 85100, France

Location

Résidence Creisker

Pornichet, 44380, France

Location

Les Jardins de Leysotte

Villenave-d'Ornon, 33140, France

Location

MeSH Terms

Conditions

Musculoskeletal Diseases; Occupational Diseases; Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Romain OLIVIER

  ergo.creisker@lna-sante.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 11, 2026
• Study Start: January 23, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)