Clinical trial NCT06305689: Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking*
Official title: Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking*
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Idiopathic Toe Walking
Keywords: Idiopathic Toe Walking
Gait
Casting
Surgery
Genomics
Motor Control
Strength
Balance and Coordination
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Gait parameters: Velocity
timeFrame: Baseline, 6 months post intervention, 1 year post intervention
measure: Gait Parameters:Stride Length (m)
timeFrame: Baseline, 6 months post intervention, 1 year post intervention
measure: Three dimensional Gait Analysis:Kinematics (degrees)
timeFrame: Baseline, 6 months post intervention, 1 year post intervention
measure: Dynamic Motor Control Index during Walking (Walk-DMC)
timeFrame: Baseline, 6 months post intervention, 1 year post intervention
measure: Three dimensional Gait Analysis:Kinetics (nm/kg)
timeFrame: Baseline, 6 months post intervention, 1 year post intervention
measure: Quantitative Assessment of Toe Walking
timeFrame: Baseline, 6 months post intervention, 1 year post intervention
measure: Pediatric Outcomes Data Collection Instrument
timeFrame: Baseline, 6 months post intervention, 1 year post intervention
Secondary outcomes:
measure: Passive Range of Motion
timeFrame: Baseline, 6 months post intervention, 1 year post intervention
measure: Muscle Strength
timeFrame: Baseline, 6 months post intervention, 1 year post intervention
Other outcomes:
measure: The Toe Walking Tool
timeFrame: Baseline
measure: Selective Motor Control
timeFrame: Baseline
measure: Coactivation Tool
timeFrame: Baseline
measure: Bruininks-Oseretsky Test of Motor Proficiency (BOT-2)
timeFrame: Baseline
measure: Genomics
timeFrame: Baseline
Locations:
city: Sacramento
country: United States
facility: Shriners Hospitals for Children
state: California
city: Chicago
country: United States
facility: Shriners Hospitals for Children
state: Illinois
city: Lexington
country: United States
facility: Shriners Hospitals for Children
state: Kentucky
city: Portland
country: United States
facility: Shriners Hospitals for Children
state: Oregon
city: Philadelphia
country: United States
facility: Shriners Hospitals for Children
state: Pennsylvania
city: Greenville
country: United States
facility: Shriners Hospitals for Children
state: South Carolina
city: Salt Lake City
country: United States
facility: Shriners Hospitals for Children
state: Utah
city: Spokane
country: United States
facility: Shriners Children's Spokane
state: Washington
Study officials:
affiliation: Shriners Hospitals for Children-Portland
name: Jeremy Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References: