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Recruiting NCT05466383

Screening and Intervention for AIS in Haikou, Hainan Province, China

No phase Interventional AIS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise, Brace.
Who it may be relevant to
Registry conditions: AIS. Basic parameters: 9 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Screening and Intervention for Adolescent Idiopathic Scoliosis in Haikou, Hainan Province, China

Overview

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.

Interventions

  • Behavioral Exercise
    Exercise rehabilitation with Schroth method
  • Device Brace
    Wear an orthopedic brace

Primary outcome measures

  • Out-of-control rate of treatment [Time frame: 36 months]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 9 years ≤ age ≤ 16 years
  • Diagnosis of AIS
  • 10°≤Cobb's angle<45°
  • Signed informed consent form

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Haikou orthopedic and diabetes hospital, Haikou orthopedic and diabetes hospital of Shangh — Haikou

Identifiers

NCT: NCT05466383 · GTYN2022001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗