Tokyo, March 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055749) titled 'Study on the correlation between foot posture index with pelvic obliquity and coronal balance of spine in individuals with mild adolescent idiopathic scoliosis' on March 12.
Study Type:
Interventional
Study Design:
Basic Design - n-of-1
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - No treatment
Primary Sponsor:
Institute - International University of Health and Welfare
Condition:
Condition - Adolescent idiopathic scoliosis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - 80 untreated patients with mild adolescent idiopathic scoliosis including 40 subjects with thoracic carvature and 40 partupants with lumbar curvature.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Forty patients with single thoracic curvature and 40 patients with single lumbar curvature of mild AIS patients will be recruited, and 20 participants with single thoracic curvature (as group A) and 20 participants with lumbar curvature (as group B) were randomly selected as the experimental group, while the remaining 20 participants with single thoracic curvature (as group A') and 20 participants with lumbar curvature (as group B') served as the corresponding control group.
Eligibility:
Age-lower limit - 10
years-old
=
Gender - Male and Female
Key inclusion criteria - AIS patients with a single thoracic curve or a single lumbar curve between the ages of 10 and 16 years old without treatment and with a Cobb angle greater than 10 degree and less than 20 degree.The subjects understand the experimental content, voluntarily participate in the experiment, and can cooperate to complete the entire experimental process.
Key exclusion criteria - Leg length discrepancy greater than 1cm,Any movement impairment,low back pain, neurologic abnormalities observed on clinical examination,or any previous treatment for scoliosis .Double principal curves or triple principal curves,Cobb angle small than 10 degree or Cobb angle greater than 20 degree, Age does not meet.
Target Size - 80
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2024 Year 06 Month 30 Day
Date of IRB - 2024 Year 11 Month 01 Day
Anticipated trial start date - 2024 Year 07 Month 20 Day
Last follow-up date - 2025 Year 06 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063710
Disclaimer: Curated by HT Syndication.