Efficacy of Artificial Intelligence-Based Digital Therapeutics Versus Traditional Schroth Exercises for Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Absolute Change in Major Curve Cobb Angle
研究概览
简要总结
This randomized controlled trial (RCT) evaluates the efficacy of a novel Artificial Intelligence (AI)-based digital therapeutic system compared to traditional outpatient Schroth exercises for the treatment of Adolescent Idiopathic Scoliosis (AIS). The intervention utilizes a smartphone application with computer vision technology to perform remote, personalized posture analysis and generate adaptive exercise prescriptions. The study aims to determine if this "Human-in-the-Loop" AI model demonstrates superior clinical outcomes in controlling spinal curve progression and improving treatment adherence compared to standard conservative care over a 6-month period.
详细描述
Background: Adolescent Idiopathic Scoliosis (AIS) requires long-term conservative management to prevent curve progression. While Physiotherapeutic Scoliosis Specific Exercises (PSSE), such as the Schroth method, are the gold standard, their efficacy is often limited by accessibility barriers and suboptimal adherence.
Study Design: This is a parallel-group, single-blind randomized controlled trial. A total of 300 eligible adolescents (aged 10-18, Cobb angle 10-30°, Risser sign 0-2) will be randomized in a 1:1 ratio into an Intervention Group or a Control Group.
Interventions:
Intervention Group (AI-DTx): Participants utilize a smartphone application to capture standardized photos every two weeks. An AI algorithm (based on MediaPipe) extracts skeletal landmarks to classify curve patterns and assign personalized exercise modules. The system features a "Check-and-Adjust" matrix to adapt exercise intensity based on metric changes. A Clinical Research Assistant (Human-in-the-Loop) verifies all prescriptions for safety before release.
Control Group (Standard Care): Participants receive standard outpatient Schroth therapy, involving daily home exercises and monthly supervised clinic visits, following SOSORT guidelines.
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)
盲法说明
Due to the visible nature of the exercise intervention, it is not possible to blind participants or care providers. To minimize detection bias, the primary outcome (Cobb angle) will be assessed by independent radiologists who are strictly blinded to group allocation and the timing of the radiographs.
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Adolescent Idiopathic Scoliosis (AIS).
- •Age between 10 and 18 years (inclusive).
- •Cobb angle of the major curve between 10° and 30°.
- •Risser sign 0-2 (indicating skeletal immaturity).
- •Ability to operate a smartphone and follow instructions for the digital therapeutic application.
- •Patient and legal guardian provide written informed consent.
排除标准
- •Non-idiopathic scoliosis (e.g., congenital, neuromuscular, or syndromic etiology).
- •History of prior spinal surgery or currently scheduled for surgery.
- •Contraindications to exercise therapy (e.g., cardiac or respiratory insufficiency).
- •Severe cognitive or psychiatric disorders that prevent compliance with the protocol.
- •Currently receiving other scoliosis-specific treatments (e.g., bracing) outside of the study protocol (unless stratified).
研究组 & 干预措施
Standard Outpatient Schroth Therapy
Participants receive standard conservative care based on Schroth Best Practice guidelines. This involves an initial 60-minute comprehensive evaluation, followed by a personalized home exercise program (30 minutes daily). Participants attend monthly supervised sessions at the outpatient clinic for manual prescription adjustments by a certified therapist .
干预措施: Standard Outpatient Schroth Therapy (Behavioral)
AI-Based Digital Therapeutics (AI-DTx)
Participants utilize a smartphone application to capture standardized photos every two weeks. An AI algorithm (MediaPipe-based) processes these images to classify curve patterns and assign personalized exercise modules. The system uses a "Human-in-the-Loop" workflow where a Clinical Research Assistant verifies the AI-generated prescription before release. Dosing intensity is adaptively adjusted based on metric changes.
干预措施: AI-Based Digital Therapeutic System (Device)
结局指标
主要结局
Absolute Change in Major Curve Cobb Angle
时间窗: Baseline, 3 months, and 6 months
Measured on standardized standing posteroanterior full-spine radiographs. The Cobb angle is the angle formed between the upper endplate of the most tilted upper vertebra and the lower endplate of the most tilted lower vertebra. Measurements are performed in degrees by independent radiologists who are blinded to group allocation. A negative value indicates a reduction (improvement) in the spinal curve.
Absolute Change in Major Curve Cobb Angle
时间窗: 0,3,5,6month
Measured on standardized standing posteroanterior full-spine radiographs. The Cobb angle is the angle formed between the upper endplate of the most tilted upper vertebra and the lower endplate of the most tilted lower vertebra. Measurements are performed in degrees by independent radiologists who are blinded to group allocation. A negative value indicates a reduction (improvement) in the spinal curve.
次要结局
- Treatment Adherence Rate(Baseline, 3 months, and 6 months)
- Change in Angle of Trunk Rotation (ATR)(Baseline, 3 months, and 6 months)
- Change in Quality of Life (SRS-22r Score)(Baseline, 3 months, and 6 months)
- Change in Trunk Appearance Perception (TAPS)(Baseline, 3 months, and 6 months)
- Treatment Adherence Rate(0,3,5,6 months)
- Change in Angle of Trunk Rotation (ATR)(0,3,5,6 months)
- Change in Quality of Life (SRS-22r Score)(0,3,5,6 months)
研究者
Ma Ruisi
Lecturer
Jinan University Guangzhou