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

NCT01776736 | Completed DMC

• 1 other identifier: ITF-237-11
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Scoliosis; Posture correction

Outcome Measures

Primary Outcomes (1)

• Progression of the spinal curve

  No progression of the spinal curve (no increase of Cobb angle) by radiographic measures.

  From baseline to 6 months

Secondary Outcomes (2)

• Progression of the spinal curve

  From baseline to 6 months

• Posture improvement

  From baseline to 6 months

Study Arms (1)

Posture Correction Girdle

EXPERIMENTAL

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

Device: Posture Correction Girdle

Interventions

Posture Correction Girdle DEVICE

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

Posture Correction Girdle

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, China

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Joanne Yip, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

• Kit-Lun Yick, Ph.D

  The Hong Kong Polytechnic University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 28, 2013
• Study Start: July 1, 2012
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2021
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

CN (1)