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Completed

NCT Number: NCT04012125

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

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Key information

Conditions

Cerebral Palsy Bone Diseases Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Musculoskeletal Diseases Nervous System Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul national university bundang hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flexible thoracolumbar brace

Device

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

Primary outcomes

  1. Change of scoliosis

    Time frame: 6months

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

Secondary outcomes

  1. Pain of the back (thorax)

    Time frame: 6 months

    Patients check the scale through the visual analog scale

  2. change of quality of life (aspect of the parents)

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 9, 2019
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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