← Back to Search

Procedure

Serial Casting for Idiopathic Toe Walking (ITW Trial)

N/A

Recruiting

Led By Jeremy Bauer, MD

Research Sponsored by Shriners Hospitals for Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months post intervention, 1 year post intervention

Awards & highlights

ITW Trial Summary

This trial aims to study the outcomes of treating children with idiopathic toe walking either without surgery (casting) or with surgery. The goal is to see which treatment option leads to better results in terms of

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Serial casting may lead to skin irritation, discomfort, or temporary muscle weakness. Surgical intervention carries risks such as infection, pain, scarring, and potential complications related to anesthesia.

ITW Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months post intervention, 1 year post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months post intervention, 1 year post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months post intervention, 1 year post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dynamic Motor Control Index during Walking (Walk-DMC)

Gait Paremeters:Stride Length (m)

Gait parameters: Velocity

+4 more

Secondary outcome measures

Muscle Strength

Passive Range of Motion

Other outcome measures

Bruininks-Oseretsky Test of Motor Proficiency (BOT-2)

Coactivation Tool

Genomics

+2 more

ITW Trial Design

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Shriners Hospitals for ChildrenLead Sponsor

97 Previous Clinical Trials

23,784 Total Patients Enrolled

Jeremy Bauer, MDPrincipal InvestigatorShriners Hospitals for Children-Portland

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the criteria to participate in this experimental study?

"Patients aged between 6 and 18 with a diagnosis of idiopathic toe walking are eligible to participate in this study, which aims to recruit a total of 180 participants."

Answered by AI

What is the current number of individuals who are being enrolled in this medical study?

"Indeed, the current data on clinicaltrials.gov confirms that patient recruitment is ongoing for this trial. The initial posting of the trial occurred on January 1st, 2022, and the most recent update was made on March 4th, 2024. This study aims to enroll a total of 180 participants distributed across eight designated locations."

Answered by AI

Are there ongoing efforts to enroll participants in this research study?

"Information from clinicaltrials.gov reveals that this research study is actively seeking eligible participants. Its initial posting was on January 1st, 2022, and the most recent update occurred on March 4th, 2024."

Answered by AI

In how many different geographical areas can patients access this clinical trial?

"This research project is conducted at 8 medical facilities. Some of the sites are situated in Portland, Chicago, and Philadelphia, among others. Selecting a nearby site for enrollment can reduce travel requirements significantly."

Answered by AI