AISNCT05466383
Screening and Intervention for AIS in Haikou, Hainan Province, China
A study testing Exercise and Brace in people with AIS, run by Chaoyin Jiang at 1 site in China.
Trial summary
This is a single-center, prospective, non-randomized, open-label, interventional, real-world study. The mild/moderate AIS patients will be recruited through screening of 250,000 primary and secondary school students in Haikou, Hainan Province. Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- AIS
- What is being tested?
- Exercise and Brace
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2022to 31 Dec 2026
- 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 9 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 9 years ≤ age ≤ 16 years
- Diagnosis of AIS
- 10°≤Cobb's angle<45°
- Signed informed consent form
Who cannot join
- With other developmental disorders, musculoskeletal disorders, nerve disorders, infection disorders, mental disorders, and other disorders
- Obvious deformity of lower limbs and(or) feet
- Previous or ongoing treatment of AIS
- Difficulty to read, understanding, and complete the study questionnaires
- Any criteria, which, in the opinion of the investigator, suggest that the subject would not be compliant with this study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Haikou orthopedic and diabetes hospital, Haikou orthopedic and diabetes hospital of Shanghai Sixth People's Hospital
Haikou, Hainan, 570300
Chaoyin Jiang, MD
Chaoyin Jiang, MD
About this study
Official title: Screening and Intervention for Adolescent Idiopathic Scoliosis in Haikou, Hainan Province, China
This is a single-center, prospective, non-randomized, open-label, interventional, real-world study. The mild/moderate AIS patients will be recruited through screening of 250,000 primary and secondary school students in Haikou, Hainan Province. The patients will be treated with different non-surgical interventions (exercise intervention or brace intervention) according to the physician's recommendations and the patient's intention. Patients will be followed up for 36 months to evaluate the effectiveness and safety of non-surgical interventions in the real world.
- Conditions
- AIS
- Being tested
- Exercise, Brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise rehabilitation with Schroth method
BraceDevice
Wear an orthopedic brace
| Study group | Role | What they receive |
|---|---|---|
| recommend exercise - perference exercise | Active comparator | Not described Receives: Behavioral: Exercise |
| recommend exercise - perference brace | Active comparator | Not described Receives: Device: Brace |
| recommend exercise - perference observation | No intervention | Not described |
| recommend brace - perference brace | Active comparator | Not described Receives: Device: Brace |
| recommend brace - perference exercise | Active comparator | Not described Receives: Behavioral: Exercise |
| recommend brace - perference observation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Out-of-control rate of treatment
Among the patients with skeletal immaturity (Risser's sign 0, 1, 2), out-of-control rate of treatment at the follow-up to 36 months or at skeletal maturity during the trial (i.e., 4° for female Risser's sign or 5° for male Risser's sign). Out-of-control rate of treatment is defined as either: Cobb angle progression >5°, or Cobb angle ≥45°, or the physician recommends or already has enhanced the intervention regimen (i.e., no intervention change to exercise intervention, no intervention change to brace intervention, or exercise intervention change to brace intervention).
Measured: 36 months
Secondary outcomes (14)
Change in SRS-22 score from baseline over time
Change in quality of life (SRS-22 score) from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment
Measured: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in vital capacity from baseline over time
Change in vital capacity from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment.
Measured: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in plantar pressure from baseline over time
Change in plantar pressure from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months after treatment compared with those before treatment.
Measured: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in gait from baseline over time
Change in gait from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment
Measured: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Correlation between the treatment compliance and the out-of-control rate of treatment
Correlation between the treatment compliance (average daily duration of treatment for scoliosis) and the out-of-control rate of treatment
Measured: 36 months
Correlation between the skeletal maturity at baseline and the out-of-control rate of treatment
Correlation between the skeletal maturity (Risser's sign) at baseline and the out-of-control rate of treatment
Measured: 36 months
Correlation between the Cobb's angle at baseline and the out-of-control rate of treatment
Correlation between the Cobb's angle at baseline and the out-of-control rate of treatment
Measured: 36 months
Correlation between the immediate correction and the out-of-control rate of treatment
Correlation between the immediate correction [(the baseline of Cobb angle - Cobb angle immediately after wearing the brace)/the baseline of Cobb angle] and the out-of-control rate of treatment
Measured: 36 months
The incidence of adverse events
The incidence of adverse events for the intervention
Measured: 36 months
The change in Cobb angle from baseline over time
The change in Cobb angle from baseline at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment compared with those before treatment
Measured: 36 months
Correlation between the treatment compliance and the change in 36-month Cobb angle from baseline
Correlation between the treatment compliance (average daily duration of treatment for scoliosis) and the change in 36-month Cobb angle from baseline
Measured: 36 months
Correlation between the skeletal maturity at baseline and the change in 36-month Cobb angle from baseline
Correlation between the skeletal maturity (Risser's sign) at baseline and the change in 36-month Cobb angle from baseline
Measured: 36 months
Correlation between the immediate correction and the change in 36-month Cobb angle from baseline
Correlation between the immediate correction [(the baseline of Cobb angle - Cobb angle immediately after wearing the brace)/the baseline of Cobb angle] and the change in 36-month Cobb angle from baseline
Measured: 36 months
Correlation between the Cobb's angle at baseline and the change in 36-month Cobb angle from baseline
Correlation between the Cobb's angle at baseline and the change in 36-month Cobb angle from baseline
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start24 Oct 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AISStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chaoyin Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chaoyin Jiang, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466383
- Sponsor's protocol ID
- GTYN2022001
- Status last verified
- Aug 2023
- First submitted
- 18 Jul 2022
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Intervention for Adolescent Idiopathic Scoliosis in Haikou, Hainan Province, China
- ClinicalTrials.gov ID
- NCT05466383
- Acronym / sponsor ID
- GTYN2022001
- Conditions
- AIS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Chaoyin JiangUniversity, hospital or other
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jul 2022 (actual)
- 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.
This is a single-center, prospective, non-randomized, open-label, interventional, real-world study. The mild/moderate AIS patients will be recruited through screening of 250,000 primary and secondary school students in Haikou, Hainan Province. The patients will be treated with different non-surgical interventions (exercise intervention or brace intervention) according to the physician's recommendations and the patient's intention. Patients will be followed up for 36 months to evaluate the effectiveness and safety of non-surgical interventions in the real world.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| recommend exercise - perference exercise | Active comparator | Behavioral: Exercise |
| recommend exercise - perference brace | Active comparator | Device: Brace |
| recommend exercise - perference observation | No intervention | – |
| recommend brace - perference brace | Active comparator | Device: Brace |
| recommend brace - perference exercise | Active comparator | Behavioral: Exercise |
| recommend brace - perference observation | No intervention | – |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 9 years ≤ age ≤ 16 years
- Diagnosis of AIS
- 10°≤Cobb's angle<45°
- Signed informed consent form
Key exclusion criteria (5 listed)
- With other developmental disorders, musculoskeletal disorders, nerve disorders, infection disorders, mental disorders, and other disorders
- Obvious deformity of lower limbs and(or) feet
- Previous or ongoing treatment of AIS
- Difficulty to read, understanding, and complete the study questionnaires
- Any criteria, which, in the opinion of the investigator, suggest that the subject would not be compliant with this study protocol
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 |
|---|---|---|
| ExerciseExercise rehabilitation with Schroth method | Behavioural | recommend brace - perference exercise, recommend exercise - perference exercise |
| BraceWear an orthopedic brace | Device | recommend brace - perference brace, recommend exercise - perference brace |
Primary outcome
Out-of-control rate of treatment
Time frame: 36 months
Among the patients with skeletal immaturity (Risser's sign 0, 1, 2), out-of-control rate of treatment at the follow-up to 36 months or at skeletal maturity during the trial (i.e., 4° for female Risser's sign or 5° for male Risser's sign). Out-of-control rate of treatment is defined as either: Cobb angle progression >5°, or Cobb angle ≥45°, or the physician recommends or already has enhanced the intervention regimen (i.e., no intervention change to exercise intervention, no intervention change to brace intervention, or exercise intervention change to brace intervention).
14 secondary outcomes
Change in SRS-22 score from baseline over time
Time frame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in vital capacity from baseline over time
Time frame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in plantar pressure from baseline over time
Time frame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in gait from baseline over time
Time frame: at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Correlation between the treatment compliance and the out-of-control rate of treatment
Time frame: 36 months
Correlation between the skeletal maturity at baseline and the out-of-control rate of treatment
Time frame: 36 months
Correlation between the Cobb's angle at baseline and the out-of-control rate of treatment
Time frame: 36 months
Correlation between the immediate correction and the out-of-control rate of treatment
Time frame: 36 months
The incidence of adverse events
Time frame: 36 months
The change in Cobb angle from baseline over time
Time frame: 36 months
Correlation between the treatment compliance and the change in 36-month Cobb angle from baseline
Time frame: 36 months
Correlation between the skeletal maturity at baseline and the change in 36-month Cobb angle from baseline
Time frame: 36 months
Correlation between the immediate correction and the change in 36-month Cobb angle from baseline
Time frame: 36 months
Correlation between the Cobb's angle at baseline and the change in 36-month Cobb angle from baseline
Time frame: 36 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 4 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for AIS
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 2/3
A Phase II/III Clinical Study of SIM0811 in the Treatment of Acute Ischemic Stroke
Acute Ischemic Stroke AIS
RecruitingPhase 2
Study of Oral MRT-2359 With Apalutamide in Prostate Cancer
Castration-Resistant Prostate Cancer (CRPC), Castration-Resistant Prostate Cancer
RecruitingPhase 3
Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer
Prostate Cancer, mHSPC
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Brace in people with AIS, run by Chaoyin Jiang 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 4 inclusion and 5 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 4 Aug 2023. 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?
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 Chaoyin Jiang, MD (+8689868603821, Jiangdoctor1979@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Out-of-control rate of treatment (time frame: 36 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 4 Aug 2023.