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TerminatedNCT03676712Updated Jul 22, 2020

The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial

An interventional study of scoliosis brace in Scoliosis Idiopathic, sponsored by Seoul National University Hospital. Terminated at 1 site in Korea, Republic of. Open to participants aged 8 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-22.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Health services research

Why this study was terminated
Recruitment of subjects was not successful.
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
8 Years to 18 Years
Sex
All
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Study summary

The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial

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Conditions studied

  • Scoliosis Idiopathic

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In context

Scoliosis

593 studies on the registry are indexed under Scoliosis; 138 are open to participants now.

This study's enrollment of 17 is below the median of 44 across 344 interventional studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • who have idiopathic scoliosis, showing at Cobb's angle over 20 degrees,less than 45 on X-ray

Exclusion criteria

Exclusion Criteria:

  • Patients who underwent spinal surgery
  • Patients with spinal scoliosis due to cerebral palsy, muscle paralysis, polio, congenital spinal abnormalities
  • Patients observed with Cobb's angle less than 20 degrees, over 45 degrees
  • Patients complaining of acute low back pain
  • Patients with cognitive impairment, severe mental illness, and inability to communicate
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    scoliosis patients

    scoliosis patients who have cobb angle over 20 degree wear scoliosis brace for six months

    Device: scoliosis brace

Interventions

  • Devicescoliosis brace

    Wear at least 18 hours a day

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What researchers measure

Primary outcomes

  1. cobb angle

    measure lateral curve of vertebra on spine x-ray AP view

    Time frame: through study completion, an average of 6 months

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Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam, Gyeonggi-do 13620, Korea, Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03676712
Lead sponsor
Seoul National University Hospital
Responsible party
Ju Seok Ryu (associate professor, Seoul National University Hospital) — Principal investigator
First posted
Sep 19, 2018
Start date
Sep 3, 2018
Primary completion
Sep 3, 2019
Completion
Sep 3, 2019
Last update
Jul 22, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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