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Effectiveness of a Digital-Based Gradual Exercise Training Program for Preventing Relapse in Congenital Clubfoot: A Protocol for a Randomized Controlled Clinical Trial

Effectiveness of a Home-Based Personalized Exercise Program for Preventing Relapse in Congenital Clubfoot: a randomized controlled trial study protocol

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087557
Enrollment
Unknown
Registered
2024-07-30
Start date
2024-07-30
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Congenital clubfoot

Interventions

Experimental group:Functional and personalized exercise training program plus the Ponseti method
Control group:Ponseti method.

Sponsors

Xinhua Hospital Afiliated to Shanghai Jiaotong University School Of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.1 Years to 5 Years

Inclusion criteria

Inclusion criteria: (1) The diagnosis of congenital clubfoot with a horseshoe-shaped deformity is characterized by the inward rotation of the forefoot, as well as the presentation of forefoot adduction, hindfoot inversion, plantar flexion, and high arch (2) Participants were born at full term (=37 weeks gestation) and had not received any previous interventions for congenital clubfoot. The treatment was initiated when the age was = 12 months. (3) The deformity has been corrected using the Ponseti method, and no previous rehabilitation treatments have been received; (4) Voluntarily participate in the study and sign an informed consent form, agreeing to follow the requirements of the study protocol.

Exclusion criteria

Exclusion criteria: (1) Postural or fetal clubfoot(Dimeglio score=5/20) (2) Clubfoot that associated with conditions that may lead to delayed motor development, such as neurological disorders (e.g., cerebral palsy) and musculoskeletal disorders (e.g., developmental dysplasia of the hip); (3) Patients with teratologic and paralytic clubfoot deformities, those who underwent surgical management for residual or recurrent deformities, and those who changed their treatment protocol (e.g., starting with the Ponseti protocol and switching to other programs) were included.

Design outcomes

Primary

MeasureTime frame
Relapse rate;

Secondary

MeasureTime frame
Pirani score;Dimeglio score;Ankle joint range of motion measurements;Anthropometric measurements;The short form 36 health survey questionnaire;Zarit Caregiver Burden Scale questionnaires; Evertor muscle clinical activity;

Countries

china

Contacts

Public ContactQimeng Fan

Xinhua Hospital Afiliated to Shanghai Jiaotong University School Of Medicine

qimeng0603@163.com+86 153 0163 1516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026