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

NCT ID: NCT03676712

Last Updated: 2020-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2019-09-03

Brief Summary

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

Detailed Description

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Conditions

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Scoliosis Idiopathic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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scoliosis patients

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

Group Type EXPERIMENTAL

scoliosis brace

Intervention Type DEVICE

Wear at least 18 hours a day

Interventions

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scoliosis brace

Wear at least 18 hours a day

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ju Seok Ryu

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-1805/471-002

Identifier Type: -

Identifier Source: org_study_id

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