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Trial of Posture Correction Girdle for Adolescents With Early Scoliosis

Primary Purpose

Scoliosis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Posture Correction Girdle
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring Posture Correction Girdle

Eligibility Criteria

10 Years - 13 Years (Child)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of AIS
  • Cobb's angle 10˚-20˚
  • Risser grade ≤ 2
  • No prior treatment
  • Pre-menarche or post- menarche by no more than 1 year
  • Ability to read and understand English or Chinese
  • Physical and mental ability to adhere to anisotropic textile braces protocol

Exclusion Criteria:

  • 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

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Posture Correction Girdle

Control

Arm Description

The design of posture correction girdle will incorporate different mechanisms, such as a) compression and pulling forces through a close fit of the intimate apparel, b) lumbar flexion by using a supporting belt, c) transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system, d) axial rotation or coupled motion by using a system with uneven straps, and e) an active mechanism that aims to shift the trunk away from areas of pressure

No treatment will be provided for control participants.

Outcomes

Primary Outcome Measures

Effectiveness of posture correction girdle
The spinal curve progression is said to be under control if the increase in the Cobb's angle is <5°

Secondary Outcome Measures

Posture improvement
Improvement of posture by clinical photographs assessment

Full Information

First Posted
November 2, 2017
Last Updated
September 22, 2023
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT03332251
Brief Title
Trial of Posture Correction Girdle for Adolescents With Early Scoliosis
Official Title
Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Adolescent idiopathic scoliosis (AIS) is a prevalent chronic condition that gradually leads to the three dimensional deformity of the spine. Spine curvature increases in youths as puberty progresses. Generally, only observation is suggested for adolescents with early scoliosis (Cobb's angle ≤ 20°). Rigid brace treatment is too draconian for them due to the high corrective force which nearly constrains all movements. Flexible brace treatment is an alternative option; however, its efficacy is still controversial. Posture correction girdle with a specialized design for teenagers with scoliosis is limited and most part of them can only provide some improvement for bad postures, such as hunchback. A scientific approach should be used to design and develop posture correction girdle as a treatment option for adolescents with early scoliosis.
Detailed Description
The design of posture correction girdle will incorporate different mechanisms, such as compression and pulling forces through a close fit of the intimate apparel lumbar flexion by using a supporting belt transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system axial rotation or coupled motion by using a system with uneven straps, and an active mechanism that aims to shift the trunk away from areas of pressure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
Posture Correction Girdle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Posture Correction Girdle
Arm Type
Experimental
Arm Description
The design of posture correction girdle will incorporate different mechanisms, such as a) compression and pulling forces through a close fit of the intimate apparel, b) lumbar flexion by using a supporting belt, c) transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system, d) axial rotation or coupled motion by using a system with uneven straps, and e) an active mechanism that aims to shift the trunk away from areas of pressure
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment will be provided for control participants.
Intervention Type
Device
Intervention Name(s)
Posture Correction Girdle
Intervention Description
Participants will be invited to undergo a fitting session of posture correction girdle. After the fitting, participants will join a 6-month wear trial of the posture correction girdle. Participants are required to wear the girdle for 8 hours a day and the compliance will be recorded by a logbook daily. Participants will be invited to undergo assessments before the wear trial, after the trial of 3 months, and after the trial of 6 months. The measure outcomes of the assessment include 1) ultrasound scanning image, 2) 3D body scan, 3) electromyography signal, 4) garment pressure, and 5) questionnaire.
Primary Outcome Measure Information:
Title
Effectiveness of posture correction girdle
Description
The spinal curve progression is said to be under control if the increase in the Cobb's angle is <5°
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Posture improvement
Description
Improvement of posture by clinical photographs assessment
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of AIS Cobb's angle 10˚-20˚ Risser grade ≤ 2 No prior treatment Pre-menarche or post- menarche by no more than 1 year Ability to read and understand English or Chinese Physical and mental ability to adhere to anisotropic textile braces protocol Exclusion Criteria: 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
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
China

12. IPD Sharing Statement

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Trial of Posture Correction Girdle for Adolescents With Early Scoliosis

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