Musculoskeletal DiseasesExo 2NCT07757737
Impact of Exoskeleton Use on Perceived Effort and Pain During Resident Handling in Nursing Home Care Staff
An observational study of Musculoskeletal Diseases and Occupational Diseases, run by LNA SANTE at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases, Occupational Diseases, Low Back Pain
- What is being tested?
- Passive back-assist exoskeleton (HAPO Version 4)
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 5 sitesFrance
- Study dates
- 23 Jan 2025to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Villa Océane
Belz, 56550
Résidence Marconi
Chatou, 78400
Les Jardins d'Olonne
Les Sables-d'Olonne, 85100
Résidence Creisker
Pornichet, 44380
Les Jardins de Leysotte
Villenave-d'Ornon, 33140
About this study
Official title: Impact of Daily Exoskeleton Use (HAPO Version 4) on Perceived Exertion and Musculoskeletal Health in Nursing Home Care Staff Performing Resident Handling in Decubitus: A Prospective Multicenter Observational Study (EXO 2)
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.
Read more
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.
Read the detailed description
- Background and Rationale Musculoskeletal disorders (MSDs) are the leading cause of occupational illness in France, accounting for 88% of recognized occupational diseases in 2019 (French Social Security data). In the healthcare sector, MSDs affect the trunk (particularly the lumbar and dorsal spine) and upper limbs of nursing staff disproportionately. Within nursing homes (EHPADs), 94% of recognized occupational diseases are MSD-related. Among LNA Santé's internal data (2023), 27.8% of all workplace accidents (WPAs) are linked to resident handling; 54% of WPAs affect care staff, primarily nursing assistants (aides-soignants, 31%), registered nurses (18%), and personal care assistants (auxiliaires de vie, 12%). The most physically demanding tasks identified include bed baths and diaper changes performed with residents in decubitus (lying) position.
- Rationale for the Intervention The HAPO exoskeleton is a passive back-assist wearable device developed by Ergo Santé (France) designed to support the upper body during forward-bending tasks. Prior phases of the LNA Santé exoskeleton research program (EXO 1, Versions 1-4) demonstrated increasing levels of satisfaction and acceptance, culminating in a 100% satisfaction rate at Version 4 among LNA Santé care staff. These early-phase studies identified initial discomfort related to device sizing and fit for female morphology, which was progressively addressed. Following these positive findings, EXO 2 was designed to assess, over a longer period and in a larger and more diverse cohort, the real-world impact of HAPO V4 on occupational fatigue, pain, and working conditions, including exploration of primary prevention (asymptomatic staff) and secondary prevention (staff with prior upper body pain history).
- Study Design EXO 2 is a prospective, multicenter, single-group, longitudinal observational study with a within-participant before-after design. No control group was included. All eligible volunteer care staff from five LNA Santé nursing home sites were enrolled. Each participant underwent a 2-week baseline observation period (without exoskeleton) followed by an 11-week exoskeleton use period. Data were collected at weekly intervals using standardized tools. Regulatory classification: This study is classified as Research Not Involving the Human Person (RNIPH) under Article L1121-1 of the French Public Health Code, in the field of human and social sciences applied to occupational health. Data collection and processing comply with CNIL Reference Methodology MR-004, ensuring pseudonymization and confidentiality without requiring review by a Committee for the Protection of Persons (CPP).
- Intervention Description HAPO Exoskeleton Version 4 (Passive Back-Assist Wearable Device) The HAPO V4 exoskeleton is a passive (non-motorized), CE-marked wearable device worn around the torso. It is designed to provide mechanical support to the dorsal and lumbar spine and upper body during forward-bending tasks, reducing muscular effort during resident handling in decubitus position (bed baths, diaper changes). The device is adjusted individually to each participant's morphology before the intervention phase. Care staff wear the exoskeleton daily during all bed baths and resident changes in lying position throughout their working shifts (day and night), for 11 consecutive weeks (Day 15 to Day 91). The exoskeleton does not replace existing patient-handling equipment (hoists, slide sheets, etc.) but supplements them. Usage is voluntary on a daily basis; reasons for non-use are recorded.
- Standard of Care / Work Context All participants continued their usual care routines. Standard patient-handling equipment available in each unit (rails, hoists, patient lifters - lève-malade and verticalisateur) was documented. Ongoing risk prevention training (PRAP - Prevention of Risks Related to Physical Activity) was provided to all site coordinators. No other ergonomic intervention was introduced during the study period.
- Visit Schedule and Procedures Visit Timing Assessments Pre-inclusion (VS) Day -7 Study presentation meeting at each site; information letter; 7-day reflection period Inclusion (V0) Day 0 Written consent; demographics, clinical data, occupational data; prior upper body pain history (past 12 months); individual exoskeleton fitting preparation Baseline V1, V2 Day 7 and Day 14 Borg scale (upper body effort); number of handling tasks; daily pain logbook (VAS) - no exoskeleton Intervention V3-V12 Day 15 to Day 84 (every 7 days) Borg scale (weekly); VAS pain (daily logbook); exoskeleton use rate and reasons for non-use (daily logbook); satisfaction (weekly); number of handling tasks (weekly) End-of-study (Vf) Day 91 Borg scale; VAS pain; exoskeleton use; satisfaction; number of handling tasks; participant verbatim Absenteeism \& WPA follow-up 3 periods vs Months 1-3 M-12 to M-10; M-3 to M-1; M4 to M6 (unit-level data)
- Assessment Tools Borg Scale (CR10 version - Perceived Exertion) The Borg CR10 is a validated ratio scale measuring subjective perceived exertion intensity. In this study, it is applied specifically to upper body effort (neck, shoulders, upper arms, back, hips/waist) experienced during resident handling tasks. Completed weekly by participants. Score ranges from 0 (nothing at all) to 10 (maximal exertion); higher score = greater perceived effort. Assessed at baseline (Day 7 and Day 14) and weekly from Day 15 to Day 91. Visual Analog Scale for Pain (VAS / EVA - Upper Body) A 10 cm visual analog scale measuring daily upper body pain intensity (neck, shoulders, upper arms, back, hips/waist). Completed daily in the participant logbook. Score ranges from 0 (no pain) to 10 (worst imaginable pain); higher score = greater pain intensity. Assessed daily from Day 0 to Day 91. Exoskeleton Satisfaction Scale A single-item numeric rating scale measuring participant satisfaction with the HAPO V4 device. Completed weekly. Score ranges from 0 (completely dissatisfied) to 10 (completely satisfied); higher score = greater satisfaction. Assessed weekly from Day 15 to Day 91. Exoskeleton Use Rate (Logbook) Daily recording in the participant logbook of whether the exoskeleton was worn (full use / partial use / not worn) during all resident handling tasks in decubitus. Reasons for non-use are also recorded. Analyzed as proportion of days with full, partial, or no use over the intervention period. Number of Resident Handling Tasks (Logbook) Weekly count of the number of bed baths and diaper changes performed by the participant during the follow-up period, used as a proxy for workload. Assessed weekly from Day 7 to Day 91. Absenteeism Rate and Workplace Accidents Unit-level data on restricted sick leave rates and number of work accidents related to resident handling, collected for three comparable periods: pre-study (M-12 to M-10), immediately before (M-3 to M-1), during (M1 to M3), and after the study. Collected from HR records. Financial and Operational Investment Data At end of study: cost per unit (rental or purchase), human resources required for implementation, training time dedicated to exoskeleton introduction. Collected from each site coordinator.
- Statistical Analysis Plan Statistical analyses were performed by a contracted biostatistician using R (v4.3.2 or later). No formal sample size calculation was performed given the exploratory nature and the constraint of volunteer availability (estimated 5-8 participants per site, 5 sites = 30-40 participants). Descriptive statistics: Continuous variables described as mean ± SD or median [IQR] (normality tested by Shapiro-Wilk); qualitative variables as frequencies and percentages. Rates are accompanied by 95% CIs (Clopper-Pearson method). Primary and secondary inferential analyses (Borg scale and VAS): At key visits, compared to baseline (V1/V2) using paired parametric (paired t-test) or non-parametric (Wilcoxon signed-rank) tests depending on normality of differences. Longitudinal mixed linear models (with participant as random effect) used to evaluate the temporal effect. Satisfaction data and handling counts analyzed by the same approach, with McNemar tests and Poisson regressions if distributions are discrete. Exoskeleton use (refused/partial/total) analyzed by McNemar test and binomial regression (refusal as event). Multivariate risk factor analyses and correlations across continuous outcomes at different visits are also planned. All tests bilateral, alpha = 5%; all confidence intervals 95%.
- Benefit-Risk Assessment Expected benefits: Reduction in perceived upper body exertion during resident handling tasks; reduction in upper body pain intensity; improvement in working conditions and quality of work life; reduction in workplace accidents and sick leave rates related to resident handling over time. Identified risks: Physical discomfort during the device adaptation period (estimated first 1-2 months of use); potential redistribution of physical load to previously unloaded muscle groups, which may cause new strain patterns; possible onset of new pain in alternative body regions during the adaptation phase. Participants are informed that withdrawal is voluntary and can occur at any time, without consequence, if discomfort or adverse effects are considered excessive.
- Regulatory and Ethical Framework This study is classified as RNIPH under French law (Article L1121-1 of the French Public Health Code) as a study in human and social sciences applied to occupational health, conducted on a voluntary basis without CPP review. Data collection and processing comply with CNIL Reference Methodology MR-004. Written informed consent was obtained from all participants. Data are pseudonymized; the correspondence list is held exclusively by the site coordinator at each participating establishment. The sponsor (LNA Santé) is the data controller. Results are compiled into an internal report and intended for publication in a peer-reviewed scientific journal. Study documents are archived for 2 years after study closure.
- Being tested
- Passive back-assist exoskeleton (HAPO Version 4)
- Keywords
- Exoskeleton, Musculoskeletal disorders, Occupational health, Nursing home, Care staff, Patient handling, Work-related pain, Assistive technology, Prevention
- Medical subject headings
- Musculoskeletal Diseases, Occupational Diseases, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive back-assist exoskeleton (HAPO Version 4)Device
Also called HAPO CS V4; HAPO exoskeleton; harness exoskeleton
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Passive back-assist exoskeleton (HAPO Version 4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
A 10 cm Visual Analog Scale measuring daily upper body pain intensity (neck, shoulders, upper arms, back, hips/waist), recorded in the participant's daily logbook. Score ranges from 0 (no pain) to 10 (worst imaginable pain); higher score = greater pain. Baseline is the daily VAS mean during the pre-exoskeleton phase (Day 0 to Day 14). Change from baseline = mean score during intervention minus mean baseline score.
Measured: 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 recording in the participant logbook of exoskeleton use during resident handling tasks: full use (worn throughout all handling tasks), partial use (worn for some tasks), or not worn (with documented reason). Analyzed as proportion of days with each category of use per participant over the 11-week intervention period. Assessed to evaluate real-world adoption and adherence.
Measured: Daily from Day 15 to Day 91
Change in Participant Satisfaction with the HAPO V4 Exoskeleton Over the Intervention Period
A single-item numeric rating scale measuring participant satisfaction with the HAPO V4 device, scored weekly by each participant. Score ranges from 0 (completely dissatisfied) to 10 (completely satisfied); higher score = greater satisfaction. Change is assessed from first week of use (Day 15) to end of study (Day 91).
Measured: Weekly from Day 15 to Day 91
Evolution of Weekly Number of Resident Handling Tasks in Decubitus During the Study Period
Weekly self-reported count of bed baths and diaper changes performed by each participant during their working shift, recorded in the daily logbook. Used as a proxy for occupational workload. Collected to assess whether changes in Borg and VAS scores might be explained by changes in workload rather than the exoskeleton effect.
Measured: Weekly from Day 7 to Day 91
Change in Restricted Absenteeism Rate in Participating Units Before, During, and After the Exoskeleton Intervention
Unit-level restricted sick leave rates collected from HR records across three comparable periods of three months each: Month -12 to Month -10 (reference period, one year prior to study), Month -3 to Month -1 (immediately before study), and Month 4 to Month 6 (post-intervention period). Compared against Month 1 to Month 3 (during study). Note: individual-level attribution is not possible; unit-level trend analysis only. Interpreted with caution given small sample size.
Measured: Retrospective data from Month -12 to Month -1 and prospective data from Month 1 to Month 6, collected at end of study
Number of Workplace Accidents Related to Resident Handling in Participating Units Before, During, and After the Exoskeleton Intervention
Unit-level count of workplace accidents related to resident handling collected from HR/occupational health records across four comparable periods of three months each: Month -12 to Month -10 (reference period, one year prior to study), Month -3 to Month -1 (immediately before study), Month 1 to Month 3 (during study), and Month 4 to Month 6 (post-intervention period). Interpreted with caution given the short observation period and small sample size.
Measured: Retrospective data from Month -12 to Month -10 and Month -3 to Month -1; prospective data from Month 1 to Month 3 and Month 4 to Month 6, collected at end of study (Day 91)
Cost of Exoskeleton Implementation per Nursing Home Unit
End-of-study collection of the total cost of exoskeleton implementation per participating nursing home unit, including device acquisition or rental cost (in euros). Collected from site coordinators at end of the study period.
Measured: End of study (Day 91)
Human Resources Required for Exoskeleton Implementation per Nursing Home Unit
End-of-study collection of the number of person-hours required for exoskeleton implementation and ongoing support per participating unit, including coordination and follow-up time provided by the risk prevention coordinator and occupational therapist. Collected from site coordinators at end of the study period.
Measured: End of study (Day 91)
Training Time Dedicated to Exoskeleton Introduction per Nursing Home Unit
End-of-study collection of the total number of hours of training dedicated to introducing the HAPO V4 exoskeleton to care staff per participating unit, as provided by the risk prevention coordinator and occupational therapist. Collected from site coordinators at end of the study period.
Measured: End of study (Day 91)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start23 Jan 2025
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- LNA SANTE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain OLIVIER, Principal investigator, ergo.creisker@lna-sante.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757737
- Sponsor's protocol ID
- Exo 2
- Acronym
- Exo 2
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. Results of this study will be disseminated through publication in a peer-reviewed scientific journal. Data are governed by the French CNIL Reference Methodology MR-004, which precludes sharing of pseudonymized individual-level data outside the study framework. The small sample size (35 participants across 5 sites) also presents a re-identification risk that precludes IPD sharing. Aggregated, anonymized results and the study protocol will be available upon publication.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Daily Exoskeleton Use (HAPO Version 4) on Perceived Exertion and Musculoskeletal Health in Nursing Home Care Staff Performing Resident Handling in Decubitus: A Prospective Multicenter Observational Study (EXO 2)
- ClinicalTrials.gov ID
- NCT07757737
- Acronym / sponsor ID
- Exo 2 / Exo 2
- Keywords
- Exoskeleton, Musculoskeletal disorders, Occupational health, Nursing home, Care staff, Patient handling, Work-related pain, Assistive technology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- LNA SANTEUniversity, hospital or other
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Background and Rationale Musculoskeletal disorders (MSDs) are the leading cause of occupational illness in France, accounting for 88% of recognized occupational diseases in 2019 (French Social Security data). In the healthcare sector, MSDs affect the trunk (particularly the lumbar and dorsal spine) and upper limbs of nursing staff disproportionately. Within nursing homes (EHPADs), 94% of recognized occupational diseases are MSD-related. Among LNA Santé's internal data (2023), 27.8% of all workplace accidents (WPAs) are linked to resident handling; 54% of WPAs affect care staff, primarily nursing assistants (aides-soignants, 31%), registered nurses (18%), and personal care assistants (auxiliaires de vie, 12%). The most physically demanding tasks identified include bed baths and diaper changes performed with residents in decubitus (lying) position.
- Rationale for the Intervention The HAPO exoskeleton is a passive back-assist wearable device developed by Ergo Santé (France) designed to support the upper body during forward-bending tasks. Prior phases of the LNA Santé exoskeleton research program (EXO 1, Versions 1-4) demonstrated increasing levels of satisfaction and acceptance, culminating in a 100% satisfaction rate at Version 4 among LNA Santé care staff. These early-phase studies identified initial discomfort related to device sizing and fit for female morphology, which was progressively addressed. Following these positive findings, EXO 2 was designed to assess, over a longer period and in a larger and more diverse cohort, the real-world impact of HAPO V4 on occupational fatigue, pain, and working conditions, including exploration of primary prevention (asymptomatic staff) and secondary prevention (staff with prior upper body pain history).
- Study Design EXO 2 is a prospective, multicenter, single-group, longitudinal observational study with a within-participant before-after design. No control group was included. All eligible volunteer care staff from five LNA Santé nursing home sites were enrolled. Each participant underwent a 2-week baseline observation period (without exoskeleton) followed by an 11-week exoskeleton use period. Data were collected at weekly intervals using standardized tools. Regulatory classification: This study is classified as Research Not Involving the Human Person (RNIPH) under Article L1121-1 of the French Public Health Code, in the field of human and social sciences applied to occupational health. Data collection and processing comply with CNIL Reference Methodology MR-004, ensuring pseudonymization and confidentiality without requiring review by a Committee for the Protection of Persons (CPP).
- Intervention Description HAPO Exoskeleton Version 4 (Passive Back-Assist Wearable Device) The HAPO V4 exoskeleton is a passive (non-motorized), CE-marked wearable device worn around the torso. It is designed to provide mechanical support to the dorsal and lumbar spine and upper body during forward-bending tasks, reducing muscular effort during resident handling in decubitus position (bed baths, diaper changes). The device is adjusted individually to each participant's morphology before the intervention phase. Care staff wear the exoskeleton daily during all bed baths and resident changes in lying position throughout their working shifts (day and night), for 11 consecutive weeks (Day 15 to Day 91). The exoskeleton does not replace existing patient-handling equipment (hoists, slide sheets, etc.) but supplements them. Usage is voluntary on a daily basis; reasons for non-use are recorded.
- Standard of Care / Work Context All participants continued their usual care routines. Standard patient-handling equipment available in each unit (rails, hoists, patient lifters - lève-malade and verticalisateur) was documented. Ongoing risk prevention training (PRAP - Prevention of Risks Related to Physical Activity) was provided to all site coordinators. No other ergonomic intervention was introduced during the study period.
- Visit Schedule and Procedures Visit Timing Assessments Pre-inclusion (VS) Day -7 Study presentation meeting at each site; information letter; 7-day reflection period Inclusion (V0) Day 0 Written consent; demographics, clinical data, occupational data; prior upper body pain history (past 12 months); individual exoskeleton fitting preparation Baseline V1, V2 Day 7 and Day 14 Borg scale (upper body effort); number of handling tasks; daily pain logbook (VAS) - no exoskeleton Intervention V3-V12 Day 15 to Day 84 (every 7 days) Borg scale (weekly); VAS pain (daily logbook); exoskeleton use rate and reasons for non-use (daily logbook); satisfaction (weekly); number of handling tasks (weekly) End-of-study (Vf) Day 91 Borg scale; VAS pain; exoskeleton use; satisfaction; number of handling tasks; participant verbatim Absenteeism \& WPA follow-up 3 periods vs Months 1-3 M-12 to M-10; M-3 to M-1; M4 to M6 (unit-level data)
- Assessment Tools Borg Scale (CR10 version - Perceived Exertion) The Borg CR10 is a validated ratio scale measuring subjective perceived exertion intensity. In this study, it is applied specifically to upper body effort (neck, shoulders, upper arms, back, hips/waist) experienced during resident handling tasks. Completed weekly by participants. Score ranges from 0 (nothing at all) to 10 (maximal exertion); higher score = greater perceived effort. Assessed at baseline (Day 7 and Day 14) and weekly from Day 15 to Day 91. Visual Analog Scale for Pain (VAS / EVA - Upper Body) A 10 cm visual analog scale measuring daily upper body pain intensity (neck, shoulders, upper arms, back, hips/waist). Completed daily in the participant logbook. Score ranges from 0 (no pain) to 10 (worst imaginable pain); higher score = greater pain intensity. Assessed daily from Day 0 to Day 91. Exoskeleton Satisfaction Scale A single-item numeric rating scale measuring participant satisfaction with the HAPO V4 device. Completed weekly. Score ranges from 0 (completely dissatisfied) to 10 (completely satisfied); higher score = greater satisfaction. Assessed weekly from Day 15 to Day 91. Exoskeleton Use Rate (Logbook) Daily recording in the participant logbook of whether the exoskeleton was worn (full use / partial use / not worn) during all resident handling tasks in decubitus. Reasons for non-use are also recorded. Analyzed as proportion of days with full, partial, or no use over the intervention period. Number of Resident Handling Tasks (Logbook) Weekly count of the number of bed baths and diaper changes performed by the participant during the follow-up period, used as a proxy for workload. Assessed weekly from Day 7 to Day 91. Absenteeism Rate and Workplace Accidents Unit-level data on restricted sick leave rates and number of work accidents related to resident handling, collected for three comparable periods: pre-study (M-12 to M-10), immediately before (M-3 to M-1), during (M1 to M3), and after the study. Collected from HR records. Financial and Operational Investment Data At end of study: cost per unit (rental or purchase), human resources required for implementation, training time dedicated to exoskeleton introduction. Collected from each site coordinator.
- Statistical Analysis Plan Statistical analyses were performed by a contracted biostatistician using R (v4.3.2 or later). No formal sample size calculation was performed given the exploratory nature and the constraint of volunteer availability (estimated 5-8 participants per site, 5 sites = 30-40 participants). Descriptive statistics: Continuous variables described as mean ± SD or median [IQR] (normality tested by Shapiro-Wilk); qualitative variables as frequencies and percentages. Rates are accompanied by 95% CIs (Clopper-Pearson method). Primary and secondary inferential analyses (Borg scale and VAS): At key visits, compared to baseline (V1/V2) using paired parametric (paired t-test) or non-parametric (Wilcoxon signed-rank) tests depending on normality of differences. Longitudinal mixed linear models (with participant as random effect) used to evaluate the temporal effect. Satisfaction data and handling counts analyzed by the same approach, with McNemar tests and Poisson regressions if distributions are discrete. Exoskeleton use (refused/partial/total) analyzed by McNemar test and binomial regression (refusal as event). Multivariate risk factor analyses and correlations across continuous outcomes at different visits are also planned. All tests bilateral, alpha = 5%; all confidence intervals 95%.
- Benefit-Risk Assessment Expected benefits: Reduction in perceived upper body exertion during resident handling tasks; reduction in upper body pain intensity; improvement in working conditions and quality of work life; reduction in workplace accidents and sick leave rates related to resident handling over time. Identified risks: Physical discomfort during the device adaptation period (estimated first 1-2 months of use); potential redistribution of physical load to previously unloaded muscle groups, which may cause new strain patterns; possible onset of new pain in alternative body regions during the adaptation phase. Participants are informed that withdrawal is voluntary and can occur at any time, without consequence, if discomfort or adverse effects are considered excessive.
- Regulatory and Ethical Framework This study is classified as RNIPH under French law (Article L1121-1 of the French Public Health Code) as a study in human and social sciences applied to occupational health, conducted on a voluntary basis without CPP review. Data collection and processing comply with CNIL Reference Methodology MR-004. Written informed consent was obtained from all participants. Data are pseudonymized; the correspondence list is held exclusively by the site coordinator at each participating establishment. The sponsor (LNA Santé) is the data controller. Results are compiled into an internal report and intended for publication in a peer-reviewed scientific journal. Study documents are archived for 2 years after study closure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Care Staff Exoskeleton Cohort | – | Device: Passive back-assist exoskeleton (HAPO Version 4)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive back-assist exoskeleton (HAPO Version 4)Also: HAPO CS V4; HAPO exoskeleton; harness exoskeletonThe 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 | Device | Care Staff Exoskeleton Cohort |
Primary outcome
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
Time frame: 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
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.
9 secondary outcomes
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
Time frame: 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
Time frame: Daily from Day 15 to Day 91
Change in Participant Satisfaction with the HAPO V4 Exoskeleton Over the Intervention Period
Time frame: Weekly from Day 15 to Day 91
Evolution of Weekly Number of Resident Handling Tasks in Decubitus During the Study Period
Time frame: Weekly from Day 7 to Day 91
Change in Restricted Absenteeism Rate in Participating Units Before, During, and After the Exoskeleton Intervention
Time frame: Retrospective data from Month -12 to Month -1 and prospective data from Month 1 to Month 6, collected at end of study
Number of Workplace Accidents Related to Resident Handling in Participating Units Before, During, and After the Exoskeleton Intervention
Time frame: Retrospective data from Month -12 to Month -10 and Month -3 to Month -1; prospective data from Month 1 to Month 3 and Month 4 to Month 6, collected at end of study (Day 91)
Cost of Exoskeleton Implementation per Nursing Home Unit
Time frame: End of study (Day 91)
Human Resources Required for Exoskeleton Implementation per Nursing Home Unit
Time frame: End of study (Day 91)
Training Time Dedicated to Exoskeleton Introduction per Nursing Home Unit
Time frame: End of study (Day 91)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. Results of this study will be disseminated through publication in a peer-reviewed scientific journal. Data are governed by the French CNIL Reference Methodology MR-004, which precludes sharing of pseudonymized individual-level data outside the study framework. The small sample size (35 participants across 5 sites) also presents a re-identification risk that precludes IPD sharing. Aggregated, anonymized results and the study protocol will be available upon publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain OLIVIER principal investigator
ergo.creisker@lna-sante.com
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Diseases and Occupational Diseases, run by LNA SANTE at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.