Elastographic Assessment of Gastrocnemius Muscle Structure in Children With Idiopathic Toe Walking

NCT07163520 | Completed

• 1 other identifier: ITW-SWE
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Idiopathic toe walking (ITW) is a gait pattern characterized by the absence of heel strike during the stance phase and incomplete foot contact with the ground. After excluding neurological, neuromuscular, and orthopedic causes such as cerebral palsy, neuropathies, myopathies, and spinal dysraphism, the diagnosis of ITW can be established. Although alterations in muscle histology and architecture have been reported in children with ITW, radiological evaluation of the musculoskeletal system remains limited. Shear Wave Elastography (SWE) is a non-invasive, objective, and cost-effective imaging technique that quantitatively assesses tissue stiffness by measuring shear wave velocity and elasticity. The present study aims to evaluate gastrocnemius muscle and Achilles tendon elasticity in children with ITW compared with age-matched healthy controls. By combining SWE measurements with clinical assessments-including ankle dorsiflexion range of motion, Toe Walking Severity Scale, Foot Posture Index, and a functionality questionnaire-we aim to better characterize the musculoskeletal alterations associated with ITW.

Conditions

Idiopathic Toe-walking

Keywords

idiopathic toe-walking; shear wave elastography; gastrocnemius; achilles

Outcome Measures

Primary Outcomes (1)

• Elastography measurements (kPa) of the gastrocnemius muscle and Achilles tendon in children with idiopathic toe walking compared to healthy controls

  The gastrocnemius is a biarticular muscle, and its stiffness may be influenced by ankle dorsiflexion and plantarflexion. In the present study, all measurements were performed with the child in the prone position. In children with idiopathic toe walking, both lower extremities were evaluated with the knees extended and the feet hanging off the examination table. Tissue elasticity (kPa) was measured from the medial gastrocnemius and Achilles tendon in three different ankle positions: neutral, passive dorsiflexion, and passive plantarflexion. For each region of interest, five measurements were obtained and averaged.Gastrocnemius muscle and Achilles tendon length was also recorded. For the control group, the same measurements were performed on the dominant lower extremity. The dominant leg was determined by asking the child which foot they would use to kick a ball.

  At study visit (baseline, cross-sectional)

Secondary Outcomes (4)

• Passive and active ankle dorsiflexion angles measured with a manual goniometer in knee flexion and extension

  At study visit (baseline, cross-sectional)

• Toe Walking Severity Scale

  At study visit (baseline, cross-sectional)

• Foot Posture Index

  At study visit (baseline, cross-sectional)

• The Pediatric Outcomes Data Collection Instrument

  At study visit (baseline, cross-sectional)

Study Arms (2)

Idiopathic Toe Walking Group

Children aged 4 to 12 years with bilateral idiopathic toe-walking pattern, defined as toe-walking gait in the absence of any underlying neurological, orthopedic, or psychiatric conditions (such as cerebral palsy, muscular dystrophies, neuropathies, autism spectrum disorder, or developmental delay).

Healthy Control Group

Age- and sex-matched typically developing children without a history of toe-walking or any neurological, orthopedic, or psychiatric disorders.

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 4 to 12 years diagnosed with bilateral idiopathic toe walking and healthy age-matched controls.

You may qualify if:

• Children aged 4 to 12 years with a bilateral idiopathic toe walking pattern Absence of neurological, orthopedic, or psychiatric conditions that could explain the toe walking gait pattern (e.g., cerebral palsy, myopathies, autism spectrum disorders, developmental disorders, neuropathies) Healthy volunteers matched for age and sex (for control group) Child and parent/guardian who were willing to participate in the study and provided written informed consent.

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: October 1, 2024
• Primary Completion: April 15, 2025
• Study Completion: May 15, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

TU (1)