NCT04012125

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2020

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

June 5, 2019

Last Update Submit

July 20, 2020

Conditions

Cerebral Palsy

Keywords

Cerebral palsyBraceScoliosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pain of the back (thorax)

    6 months

  • change of quality of life (aspect of the parents)

    6 months

Study Arms (1)

Prospective, single-arm trial

EXPERIMENTAL
Device: flexible thoracolumbar brace

Interventions

flexible thoracolumbar braceDEVICE

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

Prospective, single-arm trial

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university bundang hospital

Seongnam-si, Bundang-gu, 13354, South Korea

Location

MeSH Terms

Conditions

Cerebral PalsyScoliosis

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • JUSEOK RYU, PhD

    Seoul National University Bundang Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 5, 2019

First Posted

July 9, 2019

Study Start

September 3, 2018

Primary Completion

July 2, 2020

Study Completion

July 2, 2020

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)