Digital Physiotherapeutic Scoliosis-Specific Exercises for Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial.

IMPORTANCE

The effectiveness of a training support program of individually tailored physiotherapeutic scoliosis-specific exercises (PSSEs) delivered via a digital care system is unclear.

OBJECTIVE

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.

INTERVENTIONS

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.

MAIN OUTCOMES AND MEASURES

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.

RESULTS

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°).

CONCLUSIONS AND RELEVANCE

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.

TRIAL REGISTRATION

Chinese Clinical Trial Registry Identifier: ChiCTR2300076563.