The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012125
• Other study ID #: B-1805/471-003
• Status: Completed
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: July 2, 2020

Study information

• Verified date: July 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2, 2020
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis
• Scoliosis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university bundang hospital	Seongnam-si	Bundang-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6months
Secondary	Pain of the back (thorax)	Patients check the scale through the visual analog scale	6 months
Secondary	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	6 months