Comparing treatments for children with toe walking
Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking*
This study is testing whether casting or surgery works better for children who walk on their toes and is also looking at any genetic links to this condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Shriners Hospitals for Children Academic / other |
| Locations | 8 sites (Sacramento, California and 7 other locations) |
| Trial ID | NCT06305689 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the clinical and gait outcomes of children with idiopathic toe walking (ITW) who receive either non-operative treatment (casting) or surgical intervention. It will also investigate the potential genetic factors associated with ITW by utilizing whole genome sequencing. The study will involve 180 children aged 6-18 years, assessing their treatment responses through quantitative measurements and parent-reported outcomes. By establishing a well-defined cohort, the research seeks to provide evidence-based recommendations for managing this common pediatric condition.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6-18 years diagnosed with persistent idiopathic toe walking.
Not a fit: Patients with autism spectrum disorder or those with indications of trauma or neuromuscular influences will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for children with idiopathic toe walking, enhancing their quality of life and reducing long-term complications.
How similar studies have performed: While there have been various approaches to treating toe walking, this study's focus on genetic factors and a multi-center approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of Idiopathic Toe Walking Persistent (ITWp) 2. Between the ages of 6-18 years 3. 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: 1. Diagnosis of Autism or autism spectrum disorder 2. Presence of any indicators of trauma, neuromuscular influence or neurogenic influence as identified by using the Toe Walking Tool
Where this trial is running
Sacramento, California and 7 other locations
- Shriners Hospitals for Children — Sacramento, California, United States (Recruiting)
- Shriners Hospitals for Children — Chicago, Illinois, United States (Recruiting)
- Shriners Hospitals for Children — Lexington, Kentucky, United States (Recruiting)
- Shriners Hospitals for Children — Portland, Oregon, United States (Recruiting)
- Shriners Hospitals for Children — Philadelphia, Pennsylvania, United States (Recruiting)
- Shriners Hospitals for Children — Greenville, South Carolina, United States (Recruiting)
- Shriners Hospitals for Children — Salt Lake City, Utah, United States (Recruiting)
- Shriners Children's Spokane — Spokane, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Jeremy Bauer, MD — Shriners Hospitals for Children-Portland
- Study coordinator: Paige Lemhouse
- Email: plemhouse@shrinenet.org
- Phone: 971-544-3377
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.