CompletedNot Applicable

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

Turkey (Türkiye)46 participantsStarted 2024-10-01

Plain-language 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.

Who can participate

Age range

4 Years – 12 Years

Sex

ALL

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Inclusion Criteria: 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. \- Exclusion Criteria:Presence 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) \-

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: At study visit (baseline, cross-sectional)

Trial details

NCT IDNCT07163520

SponsorFatih Sultan Mehmet Training and Research Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-04-15

View on ClinicalTrials.gov More Idiopathic Toe-walking trials