Yuan Wangshu, Shi Weihong, Chen Lixia, Liu Di, Lin Ye, Li Qing, Lu Jiandong, Zhang Houqiang, Feng Qiyang, Zhang Huiling
Department of Rehabilitation Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Jiakang Zhongzhi Technology Company, Beijing, China.
JAMA Netw Open. 2025 Feb 3;8(2):e2459929. doi: 10.1001/jamanetworkopen.2024.59929.
The effectiveness of a training support program of individually tailored physiotherapeutic scoliosis-specific exercises (PSSEs) delivered via a digital care system is unclear.
To determine the effectiveness of a digital care program in which patients receive PSSE supervision and guidance via the Healbone Intelligent Rehabilitation System and educational videos compared with a conventional intervention involving 3 treatment sessions conducted by qualified physiotherapists at outpatient clinics or specialized orthopedic institutions and unsupervised home-based PSSE training.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial recruited patients aged 9 to 17 years from Peking Union Medical College Hospital in Beijing, China, who had adolescent idiopathic scoliosis with a primary curve Cobb angle of 10° or greater and skeletal immaturity (as determined via the Risser grading system). The trial was conducted from June 1, 2023, to August 10, 2024.
Patients were randomly assigned to a digital care (DC) group, in which each patient received fully remote and home-based PSSE training supported by a digital care system, or a usual care group, in which each patient completed 3 treatment sessions conducted by qualified physiotherapists at outpatient clinics or specialized orthopedic institutions and home-based PSSE training without supervision.
The primary outcome was a change in the Cobb angle of the major curve between baseline and month 6 of the intervention. Primary and secondary outcomes were evaluated using an independent samples t test. The proportion of patients who exhibited disease progression or improvement in the Cobb angle between the 2 groups was compared using a χ2 test.
Of 591 patients assessed for eligibility, 436 did not meet the eligibility criteria, 12 declined to participate, and 15 withdrew before randomization. The remaining 128 patients were randomized to 2 parallel groups, with 64 patients in each group (mean [SD] age, 11.1 (2.2) years; 97 female [75.8%]), all of whom completed the baseline assessment and 6-month follow-up. The mean difference in the improvement of the Cobb angle between the DC group and the usual care group after a 6-month intervention was -4.23° (95% CI, -6.08° to -2.39°) in the intention-to-treat analysis and -4.01° (95% CI, -5.68° to -2.35°) in the per-protocol analysis. The posttreatment Cobb angle was adjusted by using analysis of covariance, and the mean of the difference in the adjusted posttreatment Cobb angle between 2 groups was -4.24° (95% CI, -6.09° to -2.38°).
In this randomized clinical trial, the effectiveness of individually tailored PSSE training support delivered via a digital care system was superior to that of a conventional PSSE training model in improving the Cobb angle. This mode of exercise may be an effective and convenient alternative for individuals with adolescent idiopathic scoliosis.
Chinese Clinical Trial Registry Identifier: ChiCTR2300076563.
通过数字护理系统提供的针对个体定制的物理治疗脊柱侧弯特定运动（PSSEs）培训支持项目的有效性尚不清楚。
确定一种数字护理项目的有效性，在该项目中，患者通过Healbone智能康复系统和教育视频接受PSSE监督和指导，并与一种传统干预措施进行比较，传统干预措施包括由合格的物理治疗师在门诊诊所或专业骨科机构进行3次治疗疗程以及无监督的家庭PSSE训练。
设计、设置和参与者：这项随机临床试验从中国北京的北京协和医院招募了9至17岁的患者，这些患者患有青少年特发性脊柱侧弯，主弯Cobb角为10°或更大且骨骼未成熟（通过Risser分级系统确定）。试验于2023年6月1日至2024年8月10日进行。
患者被随机分配到数字护理（DC）组，其中每位患者接受由数字护理系统支持的完全远程和家庭式PSSE训练，或常规护理组，其中每位患者在门诊诊所或专业骨科机构由合格的物理治疗师完成3次治疗疗程以及无监督的家庭PSSE训练。
主要结局是干预基线和第6个月之间主弯Cobb角的变化。主要和次要结局使用独立样本t检验进行评估。使用χ2检验比较两组之间Cobb角出现疾病进展或改善的患者比例。
在591名评估是否符合资格的患者中，436名不符合资格标准，12名拒绝参与，15名在随机分组前退出。其余128名患者被随机分为2个平行组，每组64名患者（平均[标准差]年龄，11.1（2.2）岁；97名女性[75.8%]），所有患者均完成了基线评估和6个月随访。在意向性分析中，DC组和常规护理组在6个月干预后Cobb角改善的平均差异为-4.23°（95%置信区间，-6.08°至-2.39°），在符合方案分析中为-4.01°（95%置信区间，-5.68°至-2.35°）。通过协方差分析对治疗后Cobb角进行调整，两组之间调整后治疗后Cobb角差异的平均值为-4.24°（95%置信区间，-6.09°至-2.38°）。
在这项随机临床试验中，通过数字护理系统提供的针对个体定制的PSSE训练支持在改善Cobb角方面的有效性优于传统的PSSE训练模式。这种运动方式可能是青少年特发性脊柱侧弯患者一种有效且便捷的替代方案。
中国临床试验注册标识符：ChiCTR2300076563。
