An interventional study of thoracolumbar brace (Flexpine brace) in Neuromuscular Scoliosis, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-07-22.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention
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.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's enrollment of 12 is below the median of 44 across 344 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
longitudial study of the thoracolumbar brace in the neuromuscular scoliosis for 6 months
Device: thoracolumbar brace (Flexpine brace)
Patient's would wear the FLEXpine brace over 18 hours a day for the 6 month
change of the scoliosis
Cobb's angle in the whole spine anteroposterior view of X-ray before, immediately after, and 6-month after wearing FLEXpine brace
Time frame: 6months
change of pain
pain scale checked through the visual analog scale
Time frame: 6months
change of pulmonary function
assessed by spirometer of forced vical capacity
Time frame: 6 months
change of quality of life
Parents assessed the quality of life through the muscular dystrophy spine qusetionnaire
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital