Screening and Intervention for AIS in Haikou, Hainan Province, China
1 other identifier
interventional
5,000
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2022
CompletedFirst Posted
Study publicly available on registry
July 20, 2022
CompletedStudy Start
First participant enrolled
October 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
August 4, 2023
August 1, 2023
4.2 years
July 18, 2022
August 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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).
36 months
Secondary Outcomes (14)
Change in SRS-22 score from baseline over time
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
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
at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after treatment
Change in gait from baseline over time
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
36 months
- +9 more secondary outcomes
Other Outcomes (14)
Correlation between the age and the out-of-control rate of treatment
36 months
Correlation between the BMI at baseline and the out-of-control rate of treatment
36 months
Correlation between the type of AIS and the out-of-control rate of treatment
36 months
- +11 more other outcomes
Study Arms (6)
recommend exercise - perference exercise
ACTIVE COMPARATORrecommend exercise - perference brace
ACTIVE COMPARATORrecommend exercise - perference observation
NO INTERVENTIONrecommend brace - perference brace
ACTIVE COMPARATORrecommend brace - perference exercise
ACTIVE COMPARATORrecommend brace - perference observation
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- years ≤ age ≤ 16 years
- Diagnosis of AIS
- °≤Cobb's angle\<45°
- Signed informed consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chaoyin Jianglead
Study Sites (1)
Haikou orthopedic and diabetes hospital, Haikou orthopedic and diabetes hospital of Shanghai Sixth People's Hospital
Haikou, Hainan, 570300, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 18, 2022
First Posted
July 20, 2022
Study Start
October 24, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
August 4, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share