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OpenTrials
Completed

NCT Number: NCT07333157

Effects of Wearable Passive Back Support Suit on Back Pain in Caregivers

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.

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Key information

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male adults aged 19 years or older
  • Patient transport staff at Samsung Medical Center
  • Able to wear a wearable passive back support suit
  • Height: 156cm-188cm
  • Chest circumference: 80cm-120cm
  • Thigh circumference: 36cm-62cm

Exclusion criteria

  • Severe musculoskeletal disorders of the spine
  • Severe musculoskeletal disorders of the lower extremities
  • Contractures limiting the range of motion of the spine and lower extremities
  • Fractures, open wounds, or unhealed ulcers on the spine or lower extremities
  • Difficulty using a lumbar support device due to severe medical conditions, such as cardiovascular or pulmonary diseases
  • History of osteoporotic fractures
  • Neurological disorders affecting gait (e.g., stroke, Parkinson's disease, multiple sclerosis, etc.)
  • Any other cases where the investigator determines that participation in this study is inappropriate

Treatment and study plan

wearable passive back support suit

Device

2-week intervention periods using a wearable passive back support (Angel GEAR soft B10, Angel Robotics, Co., Ltd)

traditional lumbosacral orthosis

Device

2-week intervention periods using a traditional lumbosacral orthosis.

Primary outcomes

  1. Change in the Korean Oswestry Low Back Pain Disability Questionnaire(K-ODI) score

    Time frame: baseline, Week 2(after period 1), week 4(after washout) and week 6 (after period 2)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Acronym: back pain

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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