The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy

N/ACompletedNCT04012125

Seoul National University Hospital14 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Cerebral Palsy

Interventions

flexible thoracolumbar braceDEVICE

Subjects would wear the flexible thoracolumbar brace over 18 hours a day

Eligibility

Sex: ALLMin age: 3 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul national university bundang hospital

Seongnam-si, Bundang-gu, South Korea

Outcomes

Primary Outcomes

Change of scoliosis

Cobb's angle in the whole spine anteroposterior view of X-ray, before and immediately after, and 6months after wearing FLEXpine brace

Time frame: 6months

Secondary Outcomes

Pain of the back (thorax)

Patients check the scale through the visual analog scale

Time frame: 6 months

change of quality of life (aspect of the parents)

Parent of the patients assessed "caregiver experience with neuromuscular disease" before and 6-month after wearing FLEXpine brace

Time frame: 6 months

Data from ClinicalTrials.gov

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