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Not recruiting

Genetic Architecture

Sponsor:

Shriners Hospitals for Children

Code:

NCT06305689

Conditions

Idiopathic Toe Walking

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Interventions

Surgery

Serial Casting

Study Details

Brief 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.

Conditions

Idiopathic Toe Walking

Study ID

NCT06305689

Start date

Jan 1, 2022

Status verified date

Jul, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Serial Casting

Repeated casts weekly until desired dorsiflexion range achieved

active comparator: Surgery

Surgical procedure to the gastrocnemius and/or plantar fascia

Interventions

Surgery

Surgical procedure to the gastrocnemius and/or plantar fascia

Serial Casting

Repeated casts weekly until desired dorsiflexion range achieved

Primary outcome measure

  • Gait parameters: Velocity [ Time Frame: Baseline, 6 months post intervention, 1 year post intervention ]
  • Gait Parameters:Stride Length (m) [ Time Frame: Baseline, 6 months post intervention, 1 year post intervention ]
  • Three dimensional Gait Analysis:Kinematics (degrees) [ Time Frame: Baseline, 6 months post intervention, 1 year post intervention ]
  • Dynamic Motor Control Index during Walking (Walk-DMC) [ Time Frame: Baseline, 6 months post intervention, 1 year post intervention ]
  • Three dimensional Gait Analysis:Kinetics (nm/kg) [ Time Frame: Baseline, 6 months post intervention, 1 year post intervention ]
  • Quantitative Assessment of Toe Walking [ Time Frame: Baseline, 6 months post intervention, 1 year post intervention ]
  • Pediatric Outcomes Data Collection Instrument [ Time Frame: Baseline, 6 months post intervention, 1 year post intervention ]

Central Contacts and Locations

Central contacts

Paige Lemhouse

971-544-3377plemhouse@shrinenet.org

Susan Sienko, PhD

503-221-3481ssienko@shrinenet.org

Locations

Shriners Hospitals for Children

Recruiting

Sacramento, California, United States, 95817

Contacts

Vincent Basas

916-453-2132vincent.basas@shrinenet.org

Principal Investigator:

Jon R Davids, MD

Shriners Hospitals for Children

Recruiting

Chicago, Illinois, United States, 60707

Contacts

Ann Flanagan

773-622-5400aflanagan@shrinenet.org

Principal Investigator:

Kelsey Davidson, MD

Shriners Hospitals for Children

Recruiting

Lexington, Kentucky, United States, 40508

Contacts

Daniella Hudgins

859-268-5772Daniella.Hudgins@shrinenent.org

Principal Investigator:

Rebekah Leet, MD

Shriners Hospitals for Children

Recruiting

Portland, Oregon, United States, 97239

Contacts

Paige Lemhouse

971-544-3377plemhouse@shrinenet.org

Principal Investigator:

Jeremy Bauer, MD

Shriners Hospitals for Children

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Natalie Williams

215-430-4248Natalie.Wiliams@shrinenet.org

Principal Investigator:

Sean Waldron, MD

Shriners Hospitals for Children

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Brittney Southerland

864-255-7955Brittney.Southerland@shrinenet.org

Principal Investigator:

Lauren Hyer, MD

Shriners Hospitals for Children

Recruiting

Salt Lake City, Utah, United States, 84103

Contacts

Lisa Certer

801-536-3807Lcarter@shrinenet.org

Principal Investigator:

Kristin Carroll, MD

Shriners Children's Spokane

Recruiting

Spokane, Washington, United States, 99204

Contacts

Charlotte Preuschoff

509-623-0427cpreuschoff@shrinenet.org

Principal Investigator:

Ted Sousa, MD

More Information

Sponsor

Shriners Hospitals for Children

Last update posted

Jul 24, 2024

Last verified

Jul, 2024

Keywords

  • Idiopathic Toe Walking
  • Gait
  • Casting
  • Surgery
  • Genomics
  • Motor Control
  • Strength
  • Balance and Coordination

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Shriners Hospitals for Children on 2024-07-24.