ScoliosisNCT02271256
Functional Intimate Apparel for Adolescents With Early Scoliosis
A study testing Functional Intimate Apparel in people with Scoliosis, run by The Hong Kong Polytechnic University at 1 site in China.
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°). Read more about this study
- Who is it for?
- Ages 10 to 13 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Scoliosis
- What is being tested?
- Functional Intimate Apparel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Functional Intimate Apparel for Adolescents With Early Scoliosis
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.
Read the detailed 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.
- Conditions
- Scoliosis
- Being tested
- Functional Intimate Apparel
- Keywords
- Functional intimate apparel, Adolescent Idiopathic scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Intimate ApparelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Functional Intimate Apparel |
| Control | No intervention | Monitoring and observation will be provided during the 6-9 months wearing period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instant spinal correction
Measure lateral curvature of vertebra under x-ray. The instant effectiveness of the functional intimate apparel will be evaluated through radiography.
Measured: 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.
Measured: 6 months
Secondary outcomes (6)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 2 hours after wearing the functional intimate apparel and 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study start15 Jul 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne Yip, The Hong Kong Polytechnic University
- Investigators
- Joanne Yip, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271256
- Sponsor's protocol ID
- GRF2015
- Status last verified
- Aug 2022
- First submitted
- 20 Oct 2014
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Functional Intimate Apparel for Adolescents With Early Scoliosis
- ClinicalTrials.gov ID
- NCT02271256
- Acronym / sponsor ID
- GRF2015
- Conditions
- Scoliosis
- Keywords
- Functional intimate apparel, Adolescent Idiopathic scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Functional intimate apparel | Experimental | Device: Functional Intimate ApparelA 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. |
| Control | No intervention | –Monitoring and observation will be provided during the 6-9 months wearing period. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Intimate ApparelThe 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. | Device | Functional intimate apparel |
Primary outcome
Instant spinal correction
Time frame: 2 hours after wearing the functional intimate apparel
Measure lateral curvature of vertebra under x-ray. The instant effectiveness of the functional intimate apparel will be evaluated through radiography.
Six-month spinal control
Time frame: 6 months
Measure the lateral curvature by Scolioscan. The changes of spinal deformity over a period of 6 months will be evaluated through the sonography.
6 secondary outcomes
Contour control
Time frame: 6 months
Back muscle activity
Time frame: 6 months
Interface pressure of the functional intimate apparel
Time frame: 2 hours after wearing the functional intimate apparel and 6 months
Health-related quality of life (EQ-5D-5L)
Time frame: 6 months
Health-related quality of life (SRS-22)
Time frame: 6 months
Patients' perception of self-image (TAPS)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Yip, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Intimate Apparel in people with Scoliosis, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Instant spinal correction (time frame: 2 hours after wearing the functional intimate apparel). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.