NCT00989495已完成不适用
Single-blind Comprehensive Cohort Study Incorporating a Randomized Controlled Design on Bracing in AIS: A Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken.
研究概览
简要总结
The purpose of this study is to gain initial experience and information for proper planning and conduct of a confirmatory study (a multi-centre single-blind comprehensive cohort study of bracing).
详细描述
The study has been completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AIS
- •Age ≥10 years
- •Risser sign 0-2
- •Cobb's angle 20 deg to <25 deg with documented deterioration of at least 5 deg within the past 4 months (with a maximum of 10 days deviation), or 25 deg to <30 deg
排除标准
- •History of treatment of AIS
- •>= 1 year postmenarchal (for girls only)
- •Physical or mental disability to adhere to bracing
- •Diagnosis of musculoskeletal or development illness that might be responsible for the spinal curvature
- •Structural thoracic scoliosis with apex above T7 (Note these patients are not suitable for under-arm brace)
- •Difficulty to read, understand, and complete the study questionnaires
- •Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
研究组 & 干预措施
Brace - Randomized
Experimental
Participants were randomized to be braced
干预措施: Brace (Device)
Observation - Randomized
No Intervention
Participants were randomized to be observed only
Brace - preference based
Experimental
Participants chose to be braced
干预措施: Brace (Device)
Observation - preference-based
No Intervention
Participants chose to be observed only
结局指标
主要结局
Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken.
时间窗: Baseline and every four months
次要结局
- SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II.(Baseline and every four months)
研究者
Dr Daniel Yee Tak FONG
Associate Professor
The University of Hong Kong
研究点 (1)
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