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

NCT07333157 | Completed

• 1 other identifier: 2025-01-010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain; Exoskeleton Device

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

wearable passive back support suit

EXPERIMENTAL

Device: wearable passive back support suit

traditional lumbosacral orthosis

ACTIVE COMPARATOR

Device: traditional lumbosacral orthosis

Interventions

wearable passive back support suit DEVICE

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

wearable passive back support suit

traditional lumbosacral orthosis DEVICE

2-week intervention periods using a traditional lumbosacral orthosis.

traditional lumbosacral orthosis

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: March 21, 2025
• Primary Completion: July 24, 2025
• Study Completion: July 24, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

KR (1)