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Completed

NCT Number: NCT04012112

The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis

In the initial evaluation, the degree of spine is measured quantitatively using Cobb's angle and Muscular Dystrophy Spine Questionnaire (MDSQ). The patients who had Cobbs angle of 20-45 'by spinal plain radiography were evaluated for the effects of flexpine brace wearing and rehabilitation for 6 months. After 12 months, whole spine X-ray was taken for the followed up the patient's status.

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Key information

Conditions

Neuromuscular Scoliosis Bone Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul national university bundang hospital

Seongnam-si, Bundang, 13364, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 20-45' degrees of cobb's angle in the neuromuscular disease

Exclusion criteria

  • patient's who had spinal surgery
  • less than 20 degree or more than 45 degree of cobb's angle
  • acute lumbar pain

Treatment and study plan

thoracolumbar brace (Flexpine brace)

Device

Patient's would wear the FLEXpine brace over 18 hours a day for the 6 month

Primary outcomes

  1. change of the scoliosis

    Time frame: 6months

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

Secondary outcomes

  1. change of pain

    Time frame: 6months

    pain scale checked through the visual analog scale

  2. change of pulmonary function

    Time frame: 6 months

    assessed by spirometer of forced vical capacity

  3. change of quality of life

    Time frame: 6 months

    Parents assessed the quality of life through the muscular dystrophy spine qusetionnaire

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis : A Longitudinal Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 9, 2019
Registry last updated
Jul 22, 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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