Back Pain, Exoskeleton Device
Conditions
Brief summary
The physical demands of patient transport, including lifting and transferring patients, are significant contributors to the high risk of musculoskeletal disorders. Previous studies have demonstrated that these workers frequently experience musculoskeletal pain. Although current prevention strategies primarily consist of passive education on posture, there is a clear need for more active, assistive methods. The emergence of wearable passive back support suits as a potential solution is noteworthy; however, robust clinical research on the effectiveness of these devices in real-world care giving environments is currently lacking. The objective of this study is to investigate the effects of a wearable passive back support suit on reducing and preventing the incidence of back pain in patient transporters.
Interventions
DEVICEwearable passive back support suit
2-week intervention periods using a wearable passive back support (Angel GEAR soft B10, Angel Robotics, Co., Ltd)
DEVICEtraditional lumbosacral orthosis
2-week intervention periods using a traditional lumbosacral orthosis.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male adults aged 19 years or older 2. Patient transport staff at Samsung Medical Center 3. Able to wear a wearable passive back support suit * Height: 156cm-188cm * Chest circumference: 80cm-120cm * Thigh circumference: 36cm-62cm
Exclusion criteria
1. Severe musculoskeletal disorders of the spine 2. Severe musculoskeletal disorders of the lower extremities 3. Contractures limiting the range of motion of the spine and lower extremities 4. Fractures, open wounds, or unhealed ulcers on the spine or lower extremities 5. Difficulty using a lumbar support device due to severe medical conditions, such as cardiovascular or pulmonary diseases 6. History of osteoporotic fractures 7. Neurological disorders affecting gait (e.g., stroke, Parkinson's disease, multiple sclerosis, etc.) 8. Any other cases where the investigator determines that participation in this study is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Korean Oswestry Low Back Pain Disability Questionnaire(K-ODI) score | baseline, Week 2(after period 1), week 4(after washout) and week 6 (after period 2) |
Countries
South Korea
Outcome results
None listed