The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy

July 20, 2020 updated by: Ju Seok Ryu, Seoul National University Hospital

The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial

The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Bundang-gu
      • Seongnam-si, Bundang-gu, Korea, Republic of, 13354
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • GMFCS level III, IV, V of the Cerebral palsy
  • 20-45 degree of Cobb's angle

Exclusion Criteria:

  • less than 20 degree or more than 45 degree of Cobb's angle
  • Neuromuscular disease including congenital myopathy, spinal muscular atrophy, muscular dystrophy and poliomyelitis
  • Acute lumbar pain
  • Fixed scoliosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prospective, single-arm trial
Device: flexible thoracolumbar brace
Subjects would wear the flexible thoracolumbar brace over 18 hours a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of scoliosis
Time Frame: 6months
Cobb's angle in the whole spine anteroposterior view of X-ray, before and immediately after, and 6months after wearing FLEXpine brace
6months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain of the back (thorax)
Time Frame: 6 months
Patients check the scale through the visual analog scale
6 months
change of quality of life (aspect of the parents)
Time Frame: 6 months
Parent of the patients assessed "caregiver experience with neuromuscular disease" before and 6-month after wearing FLEXpine brace
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: JUSEOK RYU, PhD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2018

Primary Completion (Actual)

July 2, 2020

Study Completion (Actual)

July 2, 2020

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1805/471-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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