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Safety and Efficacy of Posture Correction Girdle for Adolescent With Early Scoliosis

Study of Posture Correction Girdle of Adolescents With Early Scoliosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01776736
Enrollment
50
Registered
2013-01-28
Start date
2012-07-01
Completion date
2021-12-31
Last updated
2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Scoliosis, Posture correction

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.

Interventions

Posture Correction Girdle applied for 8 hours per day. Clinical, radiographic, and self-report follow-up within the girdling period (6 months).

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
10 Years to 13 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Progression of the spinal curveFrom baseline to 6 monthsNo progression of the spinal curve (no increase of Cobb angle) by radiographic measures.

Secondary

MeasureTime frameDescription
Progression of the spinal curveFrom baseline to 6 monthsThe progression of the spinal curve within control (increase of Cobb angle \< 5 degrees)
Posture improvementFrom baseline to 6 monthsImprovement of posture by clinical photographs assessment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026