- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03329716
Brace Weaning Protocol Comparing Gradual and Immediate Weaning
A Randomized Controlled Trial Comparing Gradual and Immediate Brace Weaning Protocol
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aims of this study are: 1) To compare the degree of Cobb angle and truncal balance maintenance between immediate removal and gradual brace weaning protocols for AIS patients who have completed brace treatment; 2) To determine factors for poor maintenance of Cobb angle and truncal balance after brace weaning; 3) To determine if the current standardized criteria for initiating brace weaning is appropriate.
The investigators' hypothesis is that an AIS patient requires gradual brace weaning to allow better adaptation to an unloaded environment without the brace thereby resulting with a better truncal balance. It is also hypothesized that the immediate removal of brace for a AIS patient is as effective in terminating bracing treatment when compared to gradual brace weaning over a 6-month period.
The investigators will recruit AIS patients managed at the Duchess of Kent Children's Hospital (DKCH) in Hong Kong. As there is no definition for "brace weaning", we adopt the protocol that our center has been using. Hence the investigators will be comparing two protocols: 1) brace wearing time shortened to night wearing for 6 more months before stopping bracing altogether or 2) immediate brace weaning on the day of patient recruitment. All patients will be recruited on the day of clinic consultation where the decision for brace weaning is made. Those with underarm (Boston) bracing are included in the study. All subjects are followed-up longitudinally up to 2 years after brace weaning has been issued. Hence this includes three clinic visits with one at 6 months to complete the gradual brace weaning protocol, and at 1 and 2 years to observe for any delayed changes to the overall curvature and balance including loss of truncal balance and Cobb angle deterioration. This does not deviate significantly from our usual care as all AIS subjects are usually followed-up at 6-monthly intervals and thus this duration of follow-up is strictly adherent to and standardized.
Eligible patients who have consented to take part will be randomly allocated to one of the two protocols, and group designation will be decided by a computer-generated randomized table. Restricted randomization through blocking will be used according to the equal proportion rule (1:1). The random allocation sequence will be managed independently, and the random coding is concealed to all research staff until all data analyses have been completed. The clinicians and research assistants will not be blinded to treatment allocation, as the participants are required to implement bracing protocols and schedule longitudinal follow-up.
Apart from the Cobb angle measurement, all subjects undergo weight, height and arm span measurements, health-related quality of life (HRQOL) and utility measurements, and whole spine standing posteroanterior (PA) and lateral radiographs at each clinic visit as per routine clinic protocol. The refined Scoliosis Research Society 22-item (SRS-22r) questionnaire and the EuroQoL 5-Dimension 5-Level (EQ5D) questionnaire will thus be provided at every visit.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Please Select An Option Below
-
Hong Kong, Please Select An Option Below, Hong Kong
- Jason Pui Yin Cheung
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- All patients that are not AIS, using Milwaukee bracing, unable to comply with study follow-up, protocol issued and refused consent for study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Immediate Brace Weaning
Immediate weaning of brace
|
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
|
Other: Gradual Brace Weaning
Nocturnal brace wearing for 6 months prior to stopping brace
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Cobb Angle
Time Frame: Baseline, then 6-months, 12-months and 24-months follow-ups
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Truncal balance changes
Time Frame: Baseline, then 6-months, 12-months and 24-months follow-ups
|
Changes over time between the two groups/arms of brace-weaning protocol
|
Baseline, then 6-months, 12-months and 24-months follow-ups
|
Health-related Quality of Life measure
Time Frame: Baseline, then 6-months,12-months and 24 months follow-ups
|
The refined Chinese version of the Scoliosis Research Society-22 (SRS-22r) questionnaire
|
Baseline, then 6-months,12-months and 24 months follow-ups
|
Health-related Quality of Life measure
Time Frame: Baseline, then 6-months,12-months and 24 months follow-ups
|
The EuroQol-5 dimension (EQ-5D) utility score
|
Baseline, then 6-months,12-months and 24 months follow-ups
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Braceweaning001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adolescent Idiopathic Scoliosis
-
Cairo UniversityRecruitingScoliosis Idiopathic | Adolescent Idiopathic ScoliosisEgypt
-
Medtronic Spinal and BiologicsMedical College of Wisconsin; Syntactx; Exponent, Inc.; Medical Metrics Diagnostics...Active, not recruitingAdolescent Idiopathic Scoliosis | Juvenile Idiopathic ScoliosisUnited States, Canada, United Kingdom
-
Dr. Casey Stondell, MDPacira Pharmaceuticals, IncRecruitingAdolescent Idiopathic Scoliosis | Juvenile Idiopathic ScoliosisUnited States
-
Spino Modulation Inc.TerminatedAdolescent Idiopathic Scoliosis | Juvenile Idiopathic ScoliosisCanada
-
The University of Hong KongActive, not recruitingScoliosis | Adolescent Idiopathic Scoliosis | Idiopathic ScoliosisHong Kong
-
Uskudar UniversityRecruitingAdolescent Idiopathic ScoliosisTurkey
-
The Hong Kong Polytechnic UniversityThe University of Hong KongRecruiting
-
Stanford UniversityRecruiting
-
Turku University HospitalHelsinki University Central Hospital; Kuopio University HospitalNot yet recruitingAdolescent Idiopathic ScoliosisFinland
-
Lille Catholic UniversitySSR pédiatrique Marc SauteletRecruitingAdolescent Idiopathic ScoliosisFrance
Clinical Trials on Brace weaning
-
University of Missouri-ColumbiaTerminated
-
Felix JF HerthDLR German Aerospace Center; University Hospital Heidelberg; Federal Joint Committee and other collaboratorsRecruitingWeaning | Invasive VentilationGermany
-
BDH-Klinik Hessisch OldendorfCompletedRespiratory Insufficiency | Neurologic DisorderGermany
-
Federal University of UberlandiaCompletedWeaning Failure | Complication of Respirator [Ventilator]Brazil
-
University Hospital TuebingenNot yet recruitingAcute Respiratory Distress Syndrome
-
Seoul National University HospitalCompleted
-
St. Justine's HospitalActive, not recruitingScoliosis | Idiopathic ScoliosisCanada
-
University of California, Los AngelesRecruitingSpinal Fusion | Chronic Lower Back PainUnited States
-
Barbara ŁysońCompleted
-
Seoul National University HospitalCompletedNeuromuscular ScoliosisKorea, Republic of