Functional Intimate Apparel for Adolescents With Early Scoliosis

NCT02271256 | Completed DMC

• 1 other identifier: GRF2015
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescent idiopathic scoliosis (AIS) is a prevalent chronic condition that gradually leads to the three dimensional deformity of the spine. Spinal 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; however, its efficacy is still controversial. Functional intimate apparel 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 functional intimate apparel as a treatment option for adolescents with early scoliosis. This project aims to combine clinical experience with textiles and materials sciences to research and develop a functional intimate apparel 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 a functional intimate apparel to wear for 8 hours a day. Monitoring and observation will be provided during a 6-month wear trial. The effectiveness of the functional intimate apparel will be evaluated by pre- and post- treatment X-ray radiography and sonography.

Conditions

Scoliosis

Keywords

Functional intimate apparel; Adolescent Idiopathic scoliosis

Outcome Measures

Primary Outcomes (2)

• Instant spinal correction

  Measure lateral curvature of vertebra under x-ray. The instant effectiveness of the functional intimate apparel will be evaluated through radiography.

  2 hours after wearing the functional intimate apparel

• Six-month spinal control

  Measure the lateral curvature by Scolioscan. The changes of spinal deformity over a period of 6 months will be evaluated through the sonography.

  6 months

Secondary Outcomes (6)

• Contour control

  6 months

• Back muscle activity

  6 months

• Interface pressure of the functional intimate apparel

  2 hours after wearing the functional intimate apparel and 6 months

• Health-related quality of life (EQ-5D-5L)

  6 months

• Health-related quality of life (SRS-22)

  6 months

Study Arms (2)

Functional intimate apparel

EXPERIMENTAL

A functional intimate apparel will be provided to patient to wear it 8 hours daily. Monitoring and observation will be provided during the 6-9 months wearing period.

Device: Functional Intimate Apparel

Control

NO INTERVENTION

Monitoring and observation will be provided during the 6-9 months wearing period.

Interventions

Functional Intimate Apparel DEVICE

The design of functional intimate apparel 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 with the application of 3-point pressure system, d) axial rotation or coupled motion by using uneven straps, and e) an active mechanism that aims to shift the trunk away from areas of pressure.

Functional intimate apparel

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 10 to 13 years
• Diagnosis of AIS in early stage
• Primary Cobb angle 15-35 degrees
• Pre-menarche or post- menarche 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 functional intimate apparel 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: There are 2 groups of subjects. One group receives the treatment of functional intimate apparel which is called FIA group while one group receives observation only, which is called control group.

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 22, 2014
• Study Start: July 15, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

CN (1)