The Use of Thoraco-lumbo-sacral Orthoses (TLSOs) in the Treatment of Adolescent Idiopathic Scoliosis (AIS)

NCT ID: NCT01370057

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2017-04-30

Brief Summary

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The purpose of this study is to compare the risk of curve progression in Adolescent Idiopathic Scoliosis for subjects treated with bracing as compared to those without bracing.

Detailed Description

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Conditions

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Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment Group

Treatment with bracing

Group Type EXPERIMENTAL

Thoraco-lumbo-sacral Orthosis

Intervention Type DEVICE

Treatment with Thoraco-lumbo-sacral Orthosis for Adolescent Idiopathic Scoliosis

Control Group

Watchful waiting without bracing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Thoraco-lumbo-sacral Orthosis

Treatment with Thoraco-lumbo-sacral Orthosis for Adolescent Idiopathic Scoliosis

Intervention Type DEVICE

Other Intervention Names

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The Thoraco-lumbo-sacral Orthosis is fabricated at Prosthetic & Orthotic Department at our research facility(Prince of Wales Hospital, Hong Kong SAR, China)

Eligibility Criteria

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Inclusion Criteria

* Confirmed Diagnosis of AIS
* Age ≥10, ≤15 years old
* Risser 0, 1 or 2
* Primary Cobb angle between 20 and 40 degrees (inclusive)
* Apex (of at least one of the primary curves) caudal to T7
* Pre-menarchal OR post-menarchal by ≤1 year
* Physical and mental ability to adhere to bracing protocol

Exclusion Criteria

* Diagnosis of other musculoskeletal or developmental illnesses possibly responsible for the curvature
* A history of previous surgical or orthotic treatment
* Inability to read and understand Chinese
Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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CHENG Chun-yiu Jack

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prince of Wales Hospital

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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BRAIST HK PROTOCOL VER1

Identifier Type: -

Identifier Source: org_study_id

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