Trial of Posture Correction Girdle for Adolescents With Early Scoliosis

• Sponsor: The Hong Kong Polytechnic University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT03332251
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 82
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Scoliosis	Device: Posture Correction Girdle	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
• Actual Study Start Date: Mar 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Device: 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.
No Intervention: Control No treatment will be provided for control participants.

Outcome Measures

Primary Outcome Measures

1. Effectiveness of posture correction girdle [6 months]

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

Secondary Outcome Measures

1. Posture improvement [6 months]

   Improvement of posture by clinical photographs assessment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 13 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Hong Kong Polytechnic University	Hong Kong		China

Sponsors and Collaborators

• The Hong Kong Polytechnic University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joanne Yip, Assistant Professor, The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT03332251
• Other Study ID Numbers: GRF2017
• First Posted: Nov 6, 2017
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joanne Yip, Assistant Professor, The Hong Kong Polytechnic University: Posture Correction Girdle
• Additional relevant MeSH terms: Scoliosis

Study Results

No Results Posted as of Aug 16, 2022