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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 5
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
- 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). 4. 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. 5. 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. 6. 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) 7. 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Passive back-assist exoskeleton (HAPO Version 4) (Device)
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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)
- Number of Workplace Accidents Related to Resident Handling in Participating Units Before, During, and After the Exoskeleton Intervention(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 (Day 91))
- Human Resources Required for Exoskeleton Implementation per Nursing Home Unit(End of study (Day 91))
- Training Time Dedicated to Exoskeleton Introduction per Nursing Home Unit(End of study (Day 91))