The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Device: flexible thoracolumbar brace

• Registration Number: NCT04012125
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-03
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-09
• Status Verified: 2020-07
• Primary Completion: 2020-07-02
• Study Completion: 2020-07-02
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prospective, single-arm trial	flexible thoracolumbar brace	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul national university bundang hospital; 🇰🇷 Seongnam-si, Bundang-gu, Korea, Republic of