Brace Weaning Protocol Comparing Gradual and Immediate Weaning

NCT03329716 | Completed

• 1 other identifier: Braceweaning001
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

brace weaning

Outcome Measures

Primary Outcomes (1)

• Change of Cobb Angle

  Cobb angle changes between baseline (when decision to initiate brace weaning is made) and subsequent follow-ups.

  Baseline, then 6-months, 12-months and 24-months follow-ups

Secondary Outcomes (3)

• Truncal balance changes

  Baseline, then 6-months, 12-months and 24-months follow-ups

• Health-related Quality of Life measure

  Baseline, then 6-months,12-months and 24 months follow-ups

• Health-related Quality of Life measure

  Baseline, then 6-months,12-months and 24 months follow-ups

Study Arms (2)

Immediate Brace Weaning

OTHER

Immediate weaning of brace

Other: Brace weaning

Gradual Brace Weaning

OTHER

Nocturnal brace wearing for 6 months prior to stopping brace

Other: Brace weaning

Interventions

Brace weaning OTHER

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

Gradual Brace Weaning; Immediate Brace Weaning

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• AIS patients who have been wearing underarm (Boston) bracing, and who have reached skeletal maturity based on the Scoliosis Research Society (SRS) standardized criteria: Risser stage ≥4, \>2 years post-menarche, and no growth between 2 visits. The subjects should be managed at the Duchess of Kent Children's Hospital (DKCH) in Hong Kong.

You may not qualify if:

• All patients that are not AIS, using Milwaukee bracing, unable to comply with study follow-up, protocol issued and refused consent for study

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Jason Pui Yin Cheung

Hong Kong, Please Select An Option Below, Hong Kong

Location

Related Publications (1)

• Cheung PWH, Chan OKO, Wu H, Lai MKL, Wong LPK, Tang S, Cheung JPY. Immediate vs Gradual Brace Weaning Protocols in Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial. JAMA Pediatr. 2024 Jul 1;178(7):657-668. doi: 10.1001/jamapediatrics.2024.1484.

  PMID: 38829664 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A non-blinded, randomized controlled trial for testing two brace weaning protocols, being immediate removal of brace or gradual weaning of brace, over a course of 6 months.

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: November 6, 2017
• Study Start: May 1, 2017
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 14, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)