Functional Intimate Apparel for Adolescents With Early Scoliosis

Scoliosis Clinical Trial

Official title:

Safety and Efficacy of Functional Intimate Apparel for Adolescents With Early Scoliosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271256
• Other study ID #: GRF2015
• Status: Completed
• Phase: N/A
• Start date: July 15, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 13 Years

Eligibility

Inclusion Criteria:

• 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

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

Related Conditions & MeSH terms

• Scoliosis

Intervention

Device:
• Functional Intimate Apparel
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.

Locations

Country	Name	City	State
China	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Contour control	Measure the contour asymmetry by 3D body scanner. The changes of contour asymmetry over a period of 6 months will be evaluated by the 3D scanning images.	6 months
Secondary	Back muscle activity	Measure the back muscle activity signals by the surface electromyography (sEMG) of back muscle. The changes of sEMG of back muscle over a period of 6 months will be evaluated.	6 months
Secondary	Interface pressure of the functional intimate apparel	Measure the garment interface pressure by the Pliance pressure sensor. The bio-mechanics of the functional intimate apparel are assessed by the changes of pressure distribution.	2 hours after wearing the functional intimate apparel and 6 months
Secondary	Health-related quality of life (EQ-5D-5L)	Measure the quality of life by the validated questionnaire, Euroqol (EQ-5D-5L) .The descriptive system comprises 5 dimensions in 5 questions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 0-no problems, 1-slight problems, 2-moderate problems, 3-severe problems and 4-extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number by summed that describes the patient's health state.Total score are ranged from 0 to 20. The higher values represent a worse outcome.	6 months
Secondary	Health-related quality of life (SRS-22)	Measure the quality of life by the validated questionnaire, SRS-22. The questionnaire consists of 22 questions and each question has 5 levels. The SRS-22r measures quality of life across 5 domains - Function (5 questions), Pain (5 questions) Self-Image (5 questions), Mental Health (5 questions), Satisfaction/Dissatisfaction (2 questions). The maximum score in each domain is 5 and minimum score is 1, with higher scores representing greater patient quality of life. The scores of each questions are summed to compute a total score. Total score are ranged from 22 to 110.The higher values represent a better outcome.	6 months
Secondary	Patients' perception of self-image (TAPS)	Measure the subjective impression of trunk deformity by the calidated questionnaire, Trunk Appearance Perception Scale (TAPS). The TAPS includes 3 sets of figures that depict the trunk from 3 viewpoints: looking toward the back, looking toward the head with the patient bending over and looking toward the front. Drawings are scored from 1 (greatest deformity) to 5 (smallest deformity), and a mean score is obtained. The mean score are ranged from 1 to 5. The higher mean scores represent a better outcome.	6 months