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Customized 3D-printed supramalleolar ankle braces for correction of foot deformities in children and adolescents

Patient Specific Supramalleolar Orthoses on Global Foot Deviations Using 3D Printing - 3D-SMO Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101713
Enrollment
30
Registered
2026-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: Q665- Congenital pes planus Health Condition 2: M214- Flat foot [pes planus] (acquired)

Interventions

Intervention1: Patient-specific 3D-printed supramalleolar orthosis: Patient-specific supramalleolar orthosis fabricated using three-dimensional printing technology based on individual foot morphology

Sponsors

Dr M Srushikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Weight bearing children and adolescents aged two to eighteen years. Diagnosed cases of flexible flatfoot or high arched foot. Children with hypotonia associated with global foot deviations. Presence of triplanar foot instability during weight bearing. Difficulty in standing independently. Presence of mid toe walking pattern. Children with developmental delay affecting gait and balance. Poor coordination or balance during ambulation. Participants whose parents or legal guardians are willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: Children with advanced age or poor general medical condition. Presence of knee flexion contractures. Triceps surae muscle weakness. High muscle tone or spasticity. Severe toe walking pattern. Presence of tight heel cords. Tight peroneal muscles. Fixed foot or ankle deformities requiring surgical correction.

Design outcomes

Primary

MeasureTime frame
Change in global foot alignment and deviation as measured by validated clinical assessment tools.Timepoint: Baseline, 4 weeks, and 8 weeks

Secondary

MeasureTime frame
Improvement in ankle and foot stability during gaitTimepoint: Baseline and after twelve weeks of intervention

Countries

India

Contacts

Public ContactDr Sankaralingam

Saveetha Institute of Medical and Technical Sciences (SIMATS)

sankaralingampandian@gmail.com9381052321

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026