Adolescent Idiopathic ScoliosisNCT01776736
Safety and Efficacy of Posture Correction Girdle for Adolescent With Early Scoliosis
A study testing Posture Correction Girdle in people with Adolescent Idiopathic Scoliosis, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
For AIS, the caring of patients with spinal deformities has a long and varied history. Severe spinal deformities can greatly reduce pulmonary and cardiac functions, which may lead to death from cardiopulmonary failure. Read more about this study
- Who is it for?
- Ages 10 to 13 years, women only
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Posture Correction Girdle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2012to 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
- No healthy volunteers
- Child
Who may be able to join
- Aged 10 to 13 years
- Diagnosis of AIS in early stage
- Primary Cobb angle equals to or less than 20 degrees
- Pre-menarchal or post-menarchal 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 posture correction girdle 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: Study of Posture Correction Girdle of Adolescents With Early Scoliosis
For AIS, the caring of patients with spinal deformities has a long and varied history. Severe spinal deformities can greatly reduce pulmonary and cardiac functions, which may lead to death from cardiopulmonary failure. Therefore, surgery is generally suggested when the curvature of the spine is greater than 45-50 degrees. The adverse psychological impact of orthoses treatment on patients and its poor compliance has been a well-recognised problem. Some orthotic research studies indicate that early intervention of spinal deformities is particularly desirable. Taking into consideration current clinical practices, if the curve is less than 20 degrees, even if the child is at a high risk of progressive spinal deformity during the age of 10-16 at puberty, treatment is nothing more than just observation.
This project aims to combine clinical experience with textile and materials sciences to research and develop a posture correction girdle 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 tailor-made posture correction girdles to wear it 8 hours daily. Monitoring and observation will be provided during the six months girdling period. Data will be collected before and after the girdling by X-ray radiograph for analysis, in order to comparison the spine curvature condition. Locomotion of the subject with and without wearing the posture correction girdle will also be reference.
Read the detailed description
For AIS, the caring of patients with spinal deformities has a long and varied history. Severe spinal deformities can greatly reduce pulmonary and cardiac functions, which may lead to death from cardiopulmonary failure. Therefore, surgery is generally suggested when the curvature of the spine is greater than 45-50 degrees. The adverse psychological impact of orthoses treatment on patients and its poor compliance has been a well-recognised problem. Some orthotic research studies indicate that early intervention of spinal deformities is particularly desirable. Taking into consideration current clinical practices, if the curve is less than 20 degrees, even if the child is at a high risk of progressive spinal deformity during the age of 10-16 at puberty, treatment is nothing more than just observation.
This project aims to combine clinical experience with textile and materials sciences to research and develop a posture correction girdle for adolescents with early scoliosis. As a result, this will reduce the future likelihood of brace wear or surgery.
The eligible subjects will be given tailor-made posture correction girdles. Monitoring and observation will be provided during the girdling period. Data will be collected before and after the girdling by X-ray radiograph for analysis, in order to comparison the spine curvature condition. Locomotion of the subject with and without wearing the posture correction girdle will also be reference.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Posture Correction Girdle
- Keywords
- Scoliosis, Posture correction
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posture Correction GirdleDevice
Posture Correction Girdle applied for 8 hours per day. Clinical, radiographic, and self-report follow-up within the girdling period (6 months).
| Study group | Role | What they receive |
|---|---|---|
| Posture Correction Girdle | Experimental | Posture Correction Girdle applied for 8 hours per day. Clinical, radiographic, and self-report follow-up within the girdling period (6 months). Receives: Device: Posture Correction Girdle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of the spinal curve
No progression of the spinal curve (no increase of Cobb angle) by radiographic measures.
Measured: From baseline to 6 months
Secondary outcomes (2)
Progression of the spinal curve
The progression of the spinal curve within control (increase of Cobb angle < 5 degrees)
Measured: From baseline to 6 months
Posture improvement
Improvement of posture by clinical photographs assessment
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study start1 Jul 2012
- Primary completion30 Dec 2020
- 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 Adolescent Idiopathic 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
- 50 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 UniversityKit-Lun Yick, Ph.D, Study chair, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776736
- Sponsor's protocol ID
- ITF-237-11
- Status last verified
- Aug 2022
- First submitted
- 24 Jan 2013
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
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
- Study of Posture Correction Girdle of Adolescents With Early Scoliosis
- ClinicalTrials.gov ID
- NCT01776736
- Acronym / sponsor ID
- ITF-237-11
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Scoliosis, Posture correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Jan 2013 (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.
For AIS, the caring of patients with spinal deformities has a long and varied history. Severe spinal deformities can greatly reduce pulmonary and cardiac functions, which may lead to death from cardiopulmonary failure. Therefore, surgery is generally suggested when the curvature of the spine is greater than 45-50 degrees. The adverse psychological impact of orthoses treatment on patients and its poor compliance has been a well-recognised problem. Some orthotic research studies indicate that early intervention of spinal deformities is particularly desirable. Taking into consideration current clinical practices, if the curve is less than 20 degrees, even if the child is at a high risk of progressive spinal deformity during the age of 10-16 at puberty, treatment is nothing more than just observation.
This project aims to combine clinical experience with textile and materials sciences to research and develop a posture correction girdle 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 tailor-made posture correction girdles to wear it 8 hours daily. Monitoring and observation will be provided during the six months girdling period. Data will be collected before and after the girdling by X-ray radiograph for analysis, in order to comparison the spine curvature condition. Locomotion of the subject with and without wearing the posture correction girdle will also be reference.
Detailed description
For AIS, the caring of patients with spinal deformities has a long and varied history. Severe spinal deformities can greatly reduce pulmonary and cardiac functions, which may lead to death from cardiopulmonary failure. Therefore, surgery is generally suggested when the curvature of the spine is greater than 45-50 degrees. The adverse psychological impact of orthoses treatment on patients and its poor compliance has been a well-recognised problem. Some orthotic research studies indicate that early intervention of spinal deformities is particularly desirable. Taking into consideration current clinical practices, if the curve is less than 20 degrees, even if the child is at a high risk of progressive spinal deformity during the age of 10-16 at puberty, treatment is nothing more than just observation.
This project aims to combine clinical experience with textile and materials sciences to research and develop a posture correction girdle for adolescents with early scoliosis. As a result, this will reduce the future likelihood of brace wear or surgery.
The eligible subjects will be given tailor-made posture correction girdles. Monitoring and observation will be provided during the girdling period. Data will be collected before and after the girdling by X-ray radiograph for analysis, in order to comparison the spine curvature condition. Locomotion of the subject with and without wearing the posture correction girdle will also be reference.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posture Correction Girdle | Experimental | Device: Posture Correction GirdlePosture Correction Girdle applied for 8 hours per day. Clinical, radiographic, and self-report follow-up within the girdling period (6 months). |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Aged 10 to 13 years
- Diagnosis of AIS in early stage
- Primary Cobb angle equals to or less than 20 degrees
- Pre-menarchal or post-menarchal 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 |
|---|---|---|
| Posture Correction GirdlePosture Correction Girdle applied for 8 hours per day. Clinical, radiographic, and self-report follow-up within the girdling period (6 months). | Device | Posture Correction Girdle |
Primary outcome
Progression of the spinal curve
Time frame: From baseline to 6 months
No progression of the spinal curve (no increase of Cobb angle) by radiographic measures.
2 secondary outcomes
Progression of the spinal curve
Time frame: From baseline to 6 months
Posture improvement
Time frame: From baseline to 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
Kit-Lun Yick, Ph.D study chair
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 Posture Correction Girdle in people with Adolescent Idiopathic 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?
Progression of the spinal curve (time frame: From baseline to 6 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 16 Aug 2022.