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Brace Weaning Protocol Comparing Gradual and Immediate Weaning

NCT03329716 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 369

Last updated 2023-08-14

No results posted yet for this study

Summary

This is a non-blinded, randomized controlled trial for testing two brace weaning protocols namely immediate removal of brace or gradual weaning of brace over a course of 6 months for adolescent idiopathic scoliosis (AIS) patients. These patients will have follow-up visits at 6-months, 12-months and 24-months intervals. By comparing between the two groups in terms of change of Cobb angle, truncal balance, health-related quality of life measures at the set time-points, the investigators aim to gain insights of whether different brace-weaning protocol will be more beneficial in patients' clinical and quality of life measure outcomes.

Conditions

  • Adolescent Idiopathic Scoliosis

Interventions

OTHER

Brace weaning

For AIS patients who have been wearing Boston brace and attend clinic consultation where the decision for brace weaning is made, then weaning protocol of either arm will be prescribed

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03329716 on ClinicalTrials.gov