Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking*

Idiopathic Toe Walking Clinical Trial

— ITW  

Official title:

Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking*

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06305689
• Other study ID #: 79144
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Shriners Hospitals for Children
• Contact: Paige Lemhouse
• Phone: 971-544-3377
• Email: plemhouse[@]shrinenet.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Toe walking is a very common diagnosis in children with a prevalence of 5% -24%. Persistent toe walking in children over 3 years of age often results in parental concern, provoking multiple medical visits, and a range of interventions. Additionally, toe walking has both social implications and concerns for increased foot and ankle pain in those with contracture. Idiopathic toe walking (ITW) is a diagnosis of exclusion and affirming the diagnosis, ascertaining if intervention is indicated, and determining the optimal timing and intervention strategy are not well defined in the literature. As a family history of toe walking is reported in many children with ITW, there is a strong possibility that a subset of children may have a genetic cause for the condition which may impact the clinical course and outcome of treatment. Several approaches to intervention have been suggested to address toe-walking including: observation, therapy, casting, botulinum toxin A as well as surgery to lengthen the gastroc-soleus complex at the level of the calf or Achilles tendon. The purpose of this multi-center study is to examine a well-defined cohort of children with ITW utilizing a combination of quantitative measurement tools, parent reported outcomes, and whole genome sequencing to promote an evidence-based approach to orthopaedic management of this population. One hundred and eighty children who meet the inclusion/exclusion criteria for this study will be recruited from 8 participating SHC sites (POR, NCA, SLC, CHI, PHL, SPO, GRN, LEX) and treated with either serial casting or surgery. Children will be assessed 3 times over 1 year (Baseline, 6-months and 1-year post intervention). A series of screening as well as delineated inclusion/exclusion criteria will be used to ensure the diagnosis of ITW. Clinical assessments, radiographs and 3-D gait analysis utilizing electromyography and a multi-segment foot model will be used to determine if there are differences in the range of motion, gait kinematics and kinetics, motor synergies and foot contact patterns following casting or surgery. Whole genome sequencing will be used to determine if there is a genetic basis for ITW can be identified. Analysis will focus on 1) comparing and contrasting the short and long-term outcomes following non-operative (casting) and surgical intervention to determine if one approach is more efficacious, 2) identify potential genetic determinants for ITWp and 3) identify the factors that mediate and moderate intervention efficacy. The knowledge gained from this study will promote development of an evidence-based and personalized approach to the management of ITW.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Toe Walking

Intervention

Procedure:
• Surgery
Surgical procedure to the gastrocnemius and/or plantar fascia
• Serial Casting
Repeated casts weekly until desired dorsiflexion range achieved

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children	Chicago	Illinois
United States	Shriners Hospitals for Children	Greenville	South Carolina
United States	Shriners Hospitals for Children	Lexington	Kentucky
United States	Shriners Hospitals for Children	Philadelphia	Pennsylvania
United States	Shriners Hospitals for Children	Portland	Oregon
United States	Shriners Hospitals for Children	Sacramento	California
United States	Shriners Hospitals for Children	Salt Lake City	Utah
United States	Shriners Children's Spokane	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Toe Walking Tool	This novel tool designed for screening out children who toe walk for other reasons such as neurogenic, neuromuscular, or traumatic. If any questions are answered as yes, the prinicipal invesitagor will review to determine whether a diagnosis of idiopathic toe walking is appropriate.	Baseline
Other	Selective Motor Control	Selective Voluntary Motor Control Scale is a simple clinical measure of the ability to selectively control the muscles. Selective motor control of the hip, knee, ankle, subtalar, and toe joints will be assessed using the Selective Voluntary Motor Control tool. A total of 10 points is possible for each side with higher numbers indicating more selective control.	Baseline
Other	Coactivation Tool	The coactivation tool utilizes electromyographic activity during two lower extremity activities to determine whether there is coactivation between the gastrocnemius and the quadriceps during resistive knee extension bilaterally. Abnormalities in the muscle activation pattern may be an indication of a diagnosis other than idiopathic toe walking.	Baseline
Other	Bruininks-Oseretsky Test of Motor Proficiency (BOT-2)	The subtests of Bilateral Coordination and Balance which form the Body Coordination composite score will be used ascertain coordination of children with ITW relative to age-matched norms to help characterize the population and determine if coordination influences outcome. Higher scores indicate better balance and bilateral coordination.	Baseline
Other	Genomics	Whole Genome Sequencing will be done on the participant and both biological parents (if possible) to determine if the patient and their parents have any genetic abnormalities in genes that may be associated with toe walking and to determine if the cohort as a whole have potential new genes that may be indicative of toe walking.	Baseline
Primary	Gait parameters: Velocity	Velocity (m/s) will be assessed during walking in the gait lab.	Baseline, 6 months post intervention, 1 year post intervention
Primary	Gait Paremeters:Stride Length (m)	Stride Length (m) will be assessed during walking in the gait lab.	Baseline, 6 months post intervention, 1 year post intervention
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Passive Range of Motion	Dorsiflexion with and without knee flexion, popliteal angle are measured with a goniometer and measured in degrees	Baseline, 6 months post intervention, 1 year post intervention
Secondary	Muscle Strength	A hand-held dynamometer (HHD) will be used to assess quantitative muscle strength, via a "make test" for ankle dorsiflexors/plantarflexors, and foot inverters/everters, bilaterally.	Baseline, 6 months post intervention, 1 year post intervention