Effects of Wearable Passive Back Support Suit on Back Pain in Caregivers (back pain)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, South Korea
- Samsung Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: wearable passive back support suit
|
2-week intervention periods using a wearable passive back support (Angel GEAR soft B10, Angel Robotics, Co., Ltd)
|
|
Active Comparator: traditional lumbosacral orthosis
|
2-week intervention periods using a traditional lumbosacral orthosis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
baseline, Week 2(after period 1), week 4(after washout) and week 6 (after period 2)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-01-010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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