Trial of Posture Correction Girdle for Adolescents With Early Scoliosis

NCT ID: NCT03332251

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2025-12-31

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

1. compression and pulling forces through a close fit of the intimate apparel

2. lumbar flexion by using a supporting belt

3. transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system

4. axial rotation or coupled motion by using a system with uneven straps, and

5. an active mechanism that aims to shift the trunk away from areas of pressure.

Conditions

Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Posture Correction Girdle

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

Group Type: EXPERIMENTAL

Posture Correction Girdle

Intervention Type: DEVICE

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.

Control

No treatment will be provided for control participants.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Posture Correction Girdle

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Joanne Yip

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Hong Kong Polytechnic University

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Joanne Yip, PhD

Role: primary

tcjyip@polyu.edu.hk

852-27664848

Kit-Lun Yick, PhD

Role: backup

kit-lun.yick@polyu.edu.hk

852-27666551

Other Identifiers

GRF2017

Identifier Type: -

Identifier Source: org_study_id