ScoliosisNCT02589106
Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
A study testing Anisotropic Textile Braces in people with Scoliosis, run by The Hong Kong Polytechnic University at 2 sites in China.
Trial summary
One of the most common types of 3-dimensional spinal deformities with unknown etiology in youths is adolescent idiopathic scoliosis (AIS). The spinal curvature increases as puberty progresses. Read more about this study
- Who is it for?
- Ages 10 to 14 years, women only
- Conditions the study is for
- Scoliosis
- What is being tested?
- Anisotropic Textile Braces
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2017to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Aged 10 to 14 years
- Diagnosis of AIS
- a Cobb's angle between 20 to 30 degrees
- a Risser grade of the iliac crest of ≤ 2
- 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
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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong, Guangdong, 999077
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Joanne Yip, PhD, 852-27664848, tcjyip@polyu.edu.hk
Kit-Lun Yick, PhD, 852-27666551, kit-lun.yick@polyu.edu.hk
About this study
Official title: Safety and Efficacy of Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
One of the most common types of 3-dimensional spinal deformities with unknown etiology in youths is adolescent idiopathic scoliosis (AIS). The spinal curvature increases as puberty progresses. Generally, rigid orthotic bracewear is prescribed as non-invasive treatment for moderate AIS if treatment begins early and the orthosis is worn with compliance. Obviously, teenage patients are reluctant to accept a rigid orthosis due to aesthetics and the physical constraint. Therefore, semi-rigid and flexible orthoses have been developed, but their efficacy is still controversial and there are other issues, such as high pain scores. There is clearly room for improvement. Therefore, a garment-type of bracewear will be designed and developed to correct spinal deformity, reduce the possibility of spinal curve progression, and satisfy the needs of the patients as well as take their psychological concerns into consideration.
Read the detailed description
The design of the anisotropic textile braces will provide different mechanisms with rigid, semi-rigid and flexible materials:
- axial elongation through a close fit of the brace supported with textile composites on the lateral sides of the trunk,
- 3-point pressure with push and counter-pushes through semi-rigid pads inserted inside the pocket lining,
- pulling or compression to correct kyphosis or lordosis in the sagittal plane with elastic bands,
- derotation between the pelvis and shoulders with uneven straps, and
- an active mechanism with sensors added to the brace to maintain correct posture.
- Conditions
- Scoliosis
- Being tested
- Anisotropic Textile Braces
- Keywords
- Anisotropic Textile Braces
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anisotropic Textile BracesDevice
The period of the wear trial is 12-18 months in time for each subject. Wear instructions (23 hrs per day) and wash instructions will be provided to the subjects before the wear trial. Evaluation tests based on health in consideration of the use of the anisotropic textile brace (heart and pulmonary function testing and sensory level measurements) will be carried out at the beginning of the wear trial. Clinical, radiography, self-report and follow-up after completion of the study
| Study group | Role | What they receive |
|---|---|---|
| Anisotropic Textile Braces | Experimental | The design of the anisotropic textile braces will provide different mechanisms with rigid, semi-rigid and flexible materials: a) axial elongation through a close fit of the brace supported with textile composites on the lateral sides of the trunk, b) 3-point pressure with push and counter-pushes through semi-rigid pads inserted inside the pocket lining, c) pulling or compression to correct kyphosis or lordosis in the sagittal plane with elastic bands, d) derotation between the pelvis and shoulders with uneven straps, and e) an active mechanism with sensors added to the brace to maintain correct posture. Receives: Device: Anisotropic Textile Braces |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of the spinal curve
The spinal curve is said to be under control if the increase in the Cobb's angle is <5°
Measured: 18 months
Secondary outcomes (1)
Posture improvement
Improvement of posture by clinical photographs assessment
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startJan 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589106
- Sponsor's protocol ID
- GRF2016
- Status last verified
- Mar 2025
- First submitted
- 27 Oct 2015
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT02589106
- Acronym / sponsor ID
- GRF2016
- Conditions
- Scoliosis
- Keywords
- Anisotropic Textile Braces
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Oct 2015 (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.
One of the most common types of 3-dimensional spinal deformities with unknown etiology in youths is adolescent idiopathic scoliosis (AIS). The spinal curvature increases as puberty progresses. Generally, rigid orthotic bracewear is prescribed as non-invasive treatment for moderate AIS if treatment begins early and the orthosis is worn with compliance. Obviously, teenage patients are reluctant to accept a rigid orthosis due to aesthetics and the physical constraint. Therefore, semi-rigid and flexible orthoses have been developed, but their efficacy is still controversial and there are other issues, such as high pain scores. There is clearly room for improvement. Therefore, a garment-type of bracewear will be designed and developed to correct spinal deformity, reduce the possibility of spinal curve progression, and satisfy the needs of the patients as well as take their psychological concerns into consideration.
Detailed description
The design of the anisotropic textile braces will provide different mechanisms with rigid, semi-rigid and flexible materials:
- axial elongation through a close fit of the brace supported with textile composites on the lateral sides of the trunk,
- 3-point pressure with push and counter-pushes through semi-rigid pads inserted inside the pocket lining,
- pulling or compression to correct kyphosis or lordosis in the sagittal plane with elastic bands,
- derotation between the pelvis and shoulders with uneven straps, and
- an active mechanism with sensors added to the brace to maintain correct posture.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anisotropic Textile Braces | Experimental | Device: Anisotropic Textile BracesThe design of the anisotropic textile braces will provide different mechanisms with rigid, semi-rigid and flexible materials: a) axial elongation through a close fit of the brace supported with textile composites on the lateral sides of the trunk, b) 3-point pressure with push and counter-pushes through semi-rigid pads inserted inside the pocket lining, c) pulling or compression to correct kyphosis or lordosis in the sagittal plane with elastic bands, d) derotation between the pelvis and shoulders with uneven straps, and e) an active mechanism with sensors added to the brace to maintain correct posture. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged 10 to 14 years
- Diagnosis of AIS
- a Cobb's angle between 20 to 30 degrees
- a Risser grade of the iliac crest of ≤ 2
- Pre-menarche or post- menarche by no more than 1 year
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 |
|---|---|---|
| Anisotropic Textile BracesThe period of the wear trial is 12-18 months in time for each subject. Wear instructions (23 hrs per day) and wash instructions will be provided to the subjects before the wear trial. Evaluation tests based on health in consideration of the use of the anisotropic textile brace (heart and pulmonary function testing and sensory level measurements) will be carried out at the beginning of the wear trial. Clinical, radiography, self-report and follow-up after completion of the study | Device | Anisotropic Textile Braces |
Primary outcome
Progression of the spinal curve
Time frame: 18 months
The spinal curve is said to be under control if the increase in the Cobb's angle is <5°
1 secondary outcome
Posture improvement
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anisotropic Textile Braces in people with Scoliosis, run by The Hong Kong Polytechnic University at 2 sites 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 7 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: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanne Yip, PhD (852-27664848, tcjyip@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of the spinal curve (time frame: 18 months). 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 13 Mar 2025.