CompletedNot Applicable

Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking*

United States65 participantsStarted 2022-01-01

Plain-language summary

To compare and contrast the clinical, gait and parent-reported outcomes following either non-operative (casting) or operative treatment for children with idiopathic toe walking (ITW) and determine whether there are specific genes associated with ITW.

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis of Idiopathic Toe Walking Persistent (ITWp)
. Between the ages of 6-18 years
. Passive dorsiflexion dorsiflexion with knee extension between -10 plantar flexion - + 5 degrees of dorsiflexion, DiGiovanni defined an isolated gastrocnemius contracture as maximum passive ankle dorsiflexion as \< 5 degrees with the knee in full extension

Exclusion criteria

. Diagnosis of Autism or autism spectrum disorder
. Presence of any indicators of trauma, neuromuscular influence or neurogenic influence as identified by using the Toe Walking Tool

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

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?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

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

Gait parameters: Velocity

Timeframe: Baseline, 6 months post intervention, 1 year post intervention

Gait Parameters:Stride Length (m)

Timeframe: Baseline, 6 months post intervention, 1 year post intervention

Three dimensional Gait Analysis:Kinematics (degrees)

Timeframe: Baseline, 6 months post intervention, 1 year post intervention

Dynamic Motor Control Index during Walking (Walk-DMC)

Timeframe: Baseline, 6 months post intervention, 1 year post intervention

Three dimensional Gait Analysis:Kinetics (nm/kg)

Timeframe: Baseline, 6 months post intervention, 1 year post intervention

Quantitative Assessment of Toe Walking

Timeframe: Baseline, 6 months post intervention, 1 year post intervention

Pediatric Outcomes Data Collection Instrument

Timeframe: Baseline, 6 months post intervention, 1 year post intervention

Trial details

NCT IDNCT06305689

SponsorShriners Hospitals for Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Idiopathic Toe Walking trials

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis of Idiopathic Toe Walking Persistent (ITWp)
. Between the ages of 6-18 years
. Passive dorsiflexion dorsiflexion with knee extension between -10 plantar flexion - + 5 degrees of dorsiflexion, DiGiovanni defined an isolated gastrocnemius contracture as maximum passive ankle dorsiflexion as \< 5 degrees with the knee in full extension

Exclusion criteria

. Diagnosis of Autism or autism spectrum disorder
. Presence of any indicators of trauma, neuromuscular influence or neurogenic influence as identified by using the Toe Walking Tool

What they're measuring

Gait parameters: Velocity

Timeframe: Baseline, 6 months post intervention, 1 year post intervention

Gait Parameters:Stride Length (m)

Timeframe: Baseline, 6 months post intervention, 1 year post intervention

Three dimensional Gait Analysis:Kinematics (degrees)

Timeframe: Baseline, 6 months post intervention, 1 year post intervention

Dynamic Motor Control Index during Walking (Walk-DMC)

Timeframe: Baseline, 6 months post intervention, 1 year post intervention

Three dimensional Gait Analysis:Kinetics (nm/kg)

Timeframe: Baseline, 6 months post intervention, 1 year post intervention

Quantitative Assessment of Toe Walking

Timeframe: Baseline, 6 months post intervention, 1 year post intervention

Pediatric Outcomes Data Collection Instrument

Timeframe: Baseline, 6 months post intervention, 1 year post intervention