NCT03676712

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2018

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2019

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

September 17, 2018

Last Update Submit

July 20, 2020

Conditions

Scoliosis Idiopathic

Outcome Measures

Primary Outcomes (1)

  • cobb angle

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

    through study completion, an average of 6 months

Study Arms (1)

scoliosis patients

EXPERIMENTAL

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

Device: scoliosis brace

Interventions

scoliosis braceDEVICE

Wear at least 18 hours a day

scoliosis patients

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 19, 2018

Study Start

September 3, 2018

Primary Completion

September 3, 2019

Study Completion

September 3, 2019

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

KR(1)