Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305689
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2023-11-20
Brief Title:
Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking
Sponsor:
Shriners Hospitals for Children
Organization:
Shriners Hospitals for Children
Study Overview
Official Title:
Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITW
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 inclusionexclusion 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 inclusionexclusion 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None