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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach

1 country

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 years study duration

Study Start

First participant enrolled

January 1, 2022

Completed

1.9 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed

4 months until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed

Last Updated

January 14, 2026

Status Verified

July 1, 2024

Enrollment Period

4 years

First QC Date

November 20, 2023

Last Update Submit

January 12, 2026

Conditions

Idiopathic Toe Walking

Keywords

Idiopathic Toe WalkingGaitCastingSurgeryGenomicsMotor ControlStrengthBalance and Coordination

Outcome Measures

Primary Outcomes (7)

Gait parameters: Velocity
Velocity (m/s) will be assessed during walking in the gait lab.
Baseline, 6 months post intervention, 1 year post intervention
Gait Parameters:Stride Length (m)
Stride Length (m) will be assessed during walking in the gait lab.
Baseline, 6 months post intervention, 1 year post intervention
Three dimensional Gait Analysis:Kinematics (degrees)
Kinematics as calculated from the reflective markers placed on the skin during the computerized gait analysis will allow for the computation of knee, ankle and foot kinematics during walking. Knee Kinematics (measured in degrees): Knee angle at IC, knee extension at midstance, peak knee flexion in swing. Ankle kinematics (measured in degrees): Ankle angle at IC, ankle angle at midstance, angle range of 3rd rocker, average ankle angle in stance, average ankle angle in swing. Multisegment Foot Motion (measured in degrees): ankle complex flexion, rotation, 2)midfoot flexion, rotation and 3) hallux varus and flexion rotation.
Baseline, 6 months post intervention, 1 year post intervention
Dynamic Motor Control Index during Walking (Walk-DMC)
Walk-DMC is a measure of motor control which is calculated from the dynamic muscle activity from five muscles (rectus femoris, medial and lateral hamstrings, tibialis anterior and gastrocnemius, bilaterally)
Baseline, 6 months post intervention, 1 year post intervention
Three dimensional Gait Analysis:Kinetics (nm/kg)
Ankle kinetics: peak plantarflexion moment and power absorption at loading response, power generation at terminal stance will be calculated from the force plates and gait kinematics during the walking gait analysis.
Baseline, 6 months post intervention, 1 year post intervention
Quantitative Assessment of Toe Walking
Quantitative assessment of toe walking will be obtained with the in-shoe system the NURVV/RUN. The NURVV/RUN calculates the percentage of foot contact time spent on the rearfoot, midfoot and forefoot.
Baseline, 6 months post intervention, 1 year post intervention
Pediatric Outcomes Data Collection Instrument
Daily functional musculoskeletal health will be assessed with the Pediatric Outcomes Data Collection Instrument, a questionnaire that contains 108 questions in seven domains including four functional assessment areas: upper extremity functioning, transfers and basic mobility, sports and physical function, and comfort/pain. Items have different weights, with possible scores range from three (often, sometimes, rarely or never) to five (none, very mild, moderate, severe, very severe). For most items a lower score indicates higher functioning or a more positive quality of life.
Baseline, 6 months post intervention, 1 year post intervention

Secondary Outcomes (2)

Passive Range of Motion
Baseline, 6 months post intervention, 1 year post intervention
Muscle Strength
Baseline, 6 months post intervention, 1 year post intervention

Other Outcomes (5)

The Toe Walking Tool
Baseline
Selective Motor Control
Baseline
Coactivation Tool
Baseline
+2 more other outcomes

Study Arms (2)

Serial Casting

ACTIVE COMPARATOR

Repeated casts weekly until desired dorsiflexion range achieved

Procedure: Serial Casting

Surgery

ACTIVE COMPARATOR

Surgical procedure to the gastrocnemius and/or plantar fascia

Procedure: Surgery

Interventions

SurgeryPROCEDURE

Surgical procedure to the gastrocnemius and/or plantar fascia

Surgery

Serial CastingPROCEDURE

Repeated casts weekly until desired dorsiflexion range achieved

Serial Casting

Eligibility Criteria

Age6 Years - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.