The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy

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: Cerebral Palsy
• Intervention / Treatment: Device: flexible thoracolumbar brace

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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)	Patients check the scale through the visual analog scale	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	6 months

Collaborators and Investigators

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

Study record dates

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: Scoliosis; Cerebral palsy; Brace
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Cerebral Palsy; Scoliosis; Paralysis
• 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