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Digital therapeutics for the treatment of mild adolescent idiopathic scoliosis: a study protocol for a randomized controlled trial

A study of digital therapeutics for mild adolescent idiopathic scoliosis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076105
Enrollment
Unknown
Registered
2023-09-25
Start date
2025-03-17
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Idiopathic Scoliosis

Interventions

Experimental group:Digital therapeutics

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Meets diagnostic criteria for idiopathic scoliosis; 2. Aged 10-17 years; 3. Lordotic Cobb angle 10°~20° in standing full spine X-ray; 4. Skeletal development is immature and the grade of Risser sign is 1 to 4; 5. Ability to operate cell phone programs through learning; 6. Volunteer to participate in the study and sign a written informed consent form agreeing to follow the trial protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Functional scoliosis, including unequal length of both lower limbs, hip contractures, and inflammatory stimulus-induced; 2. Patients with congenital or neurologic scoliosis or scoliosis caused by other diseases; 3. History of other systemic disorders such as neurologic, musculoskeletal, and cardiovascular; 4. Patients with contraindications to exercise who cannot tolerate exercise therapy; 5. History of spinal and lower extremity surgery; 6. Patients with a history of spinal rehabilitation or bracing; 7. Patients with poor treatment adherence, refusal of treatment, or inability to complete continuous treatment as required.

Design outcomes

Primary

MeasureTime frame
The lordotic Cobb angle;

Secondary

MeasureTime frame
Balance Function Index (Fall index);Pulmonary function indicators;Subtotal score of SRS-22;

Countries

China

Contacts

Public ContactQing Du

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

lx92128@163.com+86 21 2507 8601

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 16, 2026