180 Participants Needed

Surgery vs Casting for Idiopathic Toe Walking

(ITW Trial)

Recruiting at 7 trial locations
PL
SS
Overseen BySusan Sienko, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Shriners Hospitals for Children
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Serial Casting, Serial Casting, Progressive Casting, Sequential Casting, Surgery for idiopathic toe walking?

Research shows that surgical treatment for idiopathic toe-walking may improve walking patterns, with 22% of patients walking normally and 50% showing improvement. Serial casting, while commonly used, did not significantly change the natural progression of toe-walking.12345

Is serial casting generally safe for treating conditions like toe walking?

Serial casting is generally considered safe, but there are risks such as the cast slipping and causing foot deformities, as seen in some clubfoot treatments. Proper technique and monitoring are important to avoid complications.13567

How does the treatment of serial casting differ from other treatments for idiopathic toe walking?

Serial casting for idiopathic toe walking is unique because it involves applying a series of casts to gradually stretch and lengthen the muscles and tendons in the foot and ankle, which is different from surgery that involves physically altering the structure of the foot. Unlike dynamic splinting, which allows for continued physical therapy, serial casting typically does not permit concurrent physical therapy sessions.14589

Research Team

JB

Jeremy Bauer, MD

Principal Investigator

Shriners Hospitals for Children-Portland

Eligibility Criteria

This trial is for children with idiopathic toe walking (ITW), a condition where they walk on their toes without any known cause. The study seeks participants who have not responded to other treatments and are eligible for either non-operative or operative interventions.

Inclusion Criteria

I am between 6 and 18 years old.
I have been diagnosed with persistent idiopathic toe walking.
My ankle movement is limited, with less than 5 degrees of upward flex.

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive either serial casting or surgery for idiopathic toe walking

6 months
Weekly visits for casting or surgical follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
2 visits (in-person) at 6 months and 1 year post intervention

Genetic Analysis

Whole genome sequencing is conducted to identify potential genetic determinants of idiopathic toe walking

Baseline

Treatment Details

Interventions

  • Serial Casting
  • Surgery
Trial OverviewThe trial is testing two different approaches: serial casting, which involves applying casts to the legs to promote normal walking, and surgery aimed at correcting the toe-walking gait. It also aims to identify if specific genes are linked to ITW.
Participant Groups
2Treatment groups
Active Control
Group I: Serial CastingActive Control1 Intervention
Repeated casts weekly until desired dorsiflexion range achieved
Group II: SurgeryActive Control1 Intervention
Surgical procedure to the gastrocnemius and/or plantar fascia

Serial Casting is already approved in United States, European Union, Canada for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Serial Casting for:
  • Idiopathic Toe Walking
  • Cerebral Palsy
  • Spina Bifida
  • Muscle Spasticity
πŸ‡ͺπŸ‡Ί
Approved in European Union as Serial Casting for:
  • Idiopathic Toe Walking
  • Cerebral Palsy
  • Spina Bifida
  • Muscle Spasticity
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Approved in Canada as Serial Casting for:
  • Idiopathic Toe Walking
  • Cerebral Palsy
  • Spina Bifida
  • Muscle Spasticity

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shriners Hospitals for Children

Lead Sponsor

Trials
98
Recruited
23,900+

Findings from Research

A shortened program of the Ponseti technique for treating congenital clubfoot, involving serial casting twice a week, was effective, with 65% of patients showing improvement in less than three weeks, which is at least two weeks shorter than the traditional method.
Despite some complications, such as pressure ulcers and one case of hospital-acquired pneumonia, all patients achieved successful correction of their clubfoot, indicating that the shortened treatment program is safe and effective.
Results of shortened program of Ponseti technique for congenital clubfoot.Sugandhavesa, N., Cheewawattanachai, C., Luevitoonvechkij, S., et al.[2018]
In a study of 136 children with idiopathic toe-walking, observation showed that only 6% achieved normal gait, while 45% improved, indicating that many children may not fully outgrow the condition without intervention.
Surgical treatment resulted in a higher percentage of children walking normally (22% patient-determined, 37% physician-determined) compared to observation or casting, suggesting that surgery may have a beneficial impact, although the criteria for surgery need further clarification.
Idiopathic toe-walking: does treatment alter the natural history?Eastwood, DM., Menelaus, MB., Dickens, DR., et al.[2019]
Serial casting, followed by the use of ankle-foot orthoses, effectively improved gait in a child with autism spectrum disorder (ASD) who exhibited toe walking and equinus contractures, as evidenced by gait analysis.
The child maintained a consistent heel-toe gait pattern for two years after treatment, suggesting that this intervention can provide long-term benefits for similar cases in children with ASD.
Kinematic Gait Changes Following Serial Casting and Bracing to Treat Toe Walking in a Child With Autism.Barkocy, M., Dexter, J., Petranovich, C.[2018]

References

Results of shortened program of Ponseti technique for congenital clubfoot. [2018]
Idiopathic toe-walking: does treatment alter the natural history? [2019]
Kinematic Gait Changes Following Serial Casting and Bracing to Treat Toe Walking in a Child With Autism. [2018]
Difficulties During Ponseti Casting for the Treatment of Idiopathic Clubfoot. [2020]
Dynamic splinting home therapy for toe walking: a case report. [2021]
Complex iatrogenic clubfoot: is it a real entity? [2022]
The Influence of Achilles Tenotomy and Compliance with Foot Abduction Orthosis on the Relapse Rate of Ponseti Treatment for Idiopathic Clubfoot: A Regional Study. [2021]
Ponseti versus traditional methods of casting for idiopathic clubfoot. [2022]
Prospective, Randomized Ponseti Treatment for Clubfoot: Orthopaedic Surgeons Versus Physical Therapists. [2023]