Clinical trial NCT01776736: Safety and Efficacy of Posture Correction Girdle for Adolescent With Early Scoliosis
Official title: Study of Posture Correction Girdle of Adolescents With Early Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Scoliosis
Posture correction
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: For AIS, the caring of patients with spinal deformities has a long and varied history. Severe spinal deformities can greatly reduce pulmonary and cardiac functions, which may lead to death from cardiopulmonary failure. Therefore, surgery is generally suggested when the curvature of the spine is greater than 45-50 degrees. The adverse psychological impact of orthoses treatment on patients and its poor compliance has been a well-recognised problem. Some orthotic research studies indicate that early intervention of spinal deformities is particularly desirable. Taking into consideration current clinical practices, if the curve is less than 20 degrees, even if the child is at a high risk of progressive spinal deformity during the age of 10-16 at puberty, treatment is nothing more than just observation.

This project aims to combine clinical experience with textile and materials sciences to research and develop a posture correction girdle for adolescents with early scoliosis. As a result, this will reduce the future likelihood of brace wear or surgery.

In this study, the eligible subjects will be given tailor-made posture correction girdles to wear it 8 hours daily. Monitoring and observation will be provided during the six months girdling period. Data will be collected before and after the girdling by X-ray radiograph for analysis, in order to comparison the spine curvature condition. Locomotion of the subject with and without wearing the posture correction girdle will also be reference.

Detailed description: For AIS, the caring of patients with spinal deformities has a long and varied history. Severe spinal deformities can greatly reduce pulmonary and cardiac functions, which may lead to death from cardiopulmonary failure. Therefore, surgery is generally suggested when the curvature of the spine is greater than 45-50 degrees. The adverse psychological impact of orthoses treatment on patients and its poor compliance has been a well-recognised problem. Some orthotic research studies indicate that early intervention of spinal deformities is particularly desirable. Taking into consideration current clinical practices, if the curve is less than 20 degrees, even if the child is at a high risk of progressive spinal deformity during the age of 10-16 at puberty, treatment is nothing more than just observation.

This project aims to combine clinical experience with textile and materials sciences to research and develop a posture correction girdle for adolescents with early scoliosis. As a result, this will reduce the future likelihood of brace wear or surgery.

The eligible subjects will be given tailor-made posture correction girdles. Monitoring and observation will be provided during the girdling period. Data will be collected before and after the girdling by X-ray radiograph for analysis, in order to comparison the spine curvature condition. Locomotion of the subject with and without wearing the posture correction girdle will also be reference.

Eligibility criteria: Inclusion Criteria:

* Aged 10 to 13 years
* Diagnosis of AIS in early stage
* Primary Cobb angle equals to or less than 20 degrees
* Pre-menarchal or post-menarchal by no more than 1 year
* Ability to read and understand English or Chinese
* At high risk for curve progression
* Skeletally immature (Risser grade 0, 1, or 2)
* Physical and mental ability to adhere to posture correction girdle protocol

Exclusion Criteria:

* Contraindications for x-ray exposure
* Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
* History of previous surgical or orthotic treatment for AIS
* Contraindications for pulmonary and / or exercise tests
* Psychiatric disorders
* Recent trauma
* Recent traumatic (emotional) event

Primary outcomes:
measure: Progression of the spinal curve
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Progression of the spinal curve
timeFrame: From baseline to 6 months
measure: Posture improvement
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Joanne Yip, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hong Kong Polytechnic University
name: Kit-Lun Yick, Ph.D
role: STUDY_CHAIR
References: