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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by The Hong Kong Polytechnic University
Sponsor:
Information provided by (Responsible Party):
Joanne Yip, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01776736
First received: January 24, 2013
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Adolescent Idiopathic Scoliosis
Device: Posture Correction Girdle
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Posture Correction Girdle of Adolescents With Early Scoliosis

Resource links provided by NLM:


Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Progression of the spinal curve [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
    No progression of the spinal curve (no increase of Cobb angle) by radiographic measures.


Secondary Outcome Measures:
  • Progression of the spinal curve [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
    The progression of the spinal curve within control (increase of Cobb angle < 5 degrees)

  • Posture improvement [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
    Improvement of posture by clinical photographs assessment


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Posture Correction Girdle
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
Posture Correction Girdle applied for 8 hours per day. Clinical, radiographic, and self-report follow-up within the girdling period (6 months).

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

Ages Eligible for Study:   10 Years to 13 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776736

Contacts
Contact: Joanne Yip, Phd 852-27665111 ext 4848 joanne.yip@polyu.edu.hk

Locations
China
The Hong Kong Polytechnic University Recruiting
Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Principal Investigator: Joanne Yip, PhD The Hong Kong Polytechnic University
Study Chair: Kit-Lun Yick, Ph.D The Hong Kong Polytechnic University
  More Information

No publications provided

Responsible Party: Joanne Yip, Lecturer, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01776736     History of Changes
Other Study ID Numbers: ITF-237-11
Study First Received: January 24, 2013
Last Updated: January 28, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The Hong Kong Polytechnic University:
Scoliosis
Posture correction

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 19, 2014