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A Single-Center Prospective Exploratory Clinical Trial Evaluating the Safety and Efficacy of the AiOrtho Digital Therapeutic Device for Improving Head Tilt Angle and Cervical Range of Motion in Pediatric Patients with Congenital Muscular Torticollis

A Single-Center Prospective Exploratory Clinical Trial Evaluating the Safety and Efficacy of the AiOrtho Digital Therapeutic Device for Improving Head Tilt Angle and Cervical Range of Motion in Pediatric Patients with Congenital Muscular Torticollis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011694
Enrollment
70
Registered
2026-03-09
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

None listed

Interventions

Medical Device : 1. Experimental Group (n=35): Conventional Physical Therapy + AiOrtho Digital Therapeutic Device - Intervention: AiOrtho (AI-based digital therapeutic device, software as a medical de

Sponsors

The Catholic University of Korea, Incheon St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Infants diagnosed with congenital muscular torticollis 2. Age under 12 months 3. Sternocleidomastoid muscle abnormality confirmed by ultrasonography 4. No accompanying neuromuscular disorders 5. No skeletal abnormalities such as osseous torticollis or hemivertebra on cervical X-ray

Exclusion criteria

Exclusion criteria: 1. Presence of ophthalmic disorders 2. Hearing impairment or use of hearing aids 3. Presence of paroxysmal disorders such as photosensitivity

Design outcomes

Primary

MeasureTime frame
Head Tilt Angle—

Secondary

MeasureTime frame
Passive and Active Cervical Range of Motion (PROM/AROM)—

Countries

Korea, Republic of

Contacts

Public ContactDae-Hyun Jang

The Catholic University of Korea, Incheon St. Mary's Hospital

dhjangmd@naver.com+82-32-280-6601

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Mar 20, 2026