Idiopathic Toe WalkingITWNCT06305689
Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking*
A study testing Surgery and Serial Casting in people with Idiopathic Toe Walking, run by Shriners Hospitals for Children at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Idiopathic Toe Walking
- What is being tested?
- Surgery and Serial Casting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Jan 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Shriners Hospitals for Children
Chicago, Illinois, 60707
Shriners Hospitals for Children
Greenville, South Carolina, 29605
Shriners Hospitals for Children
Lexington, Kentucky, 40508
Shriners Hospitals for Children
Philadelphia, Pennsylvania, 19140
Shriners Hospitals for Children
Portland, Oregon, 97239
Shriners Hospitals for Children
Sacramento, California, 95817
Shriners Hospitals for Children
Salt Lake City, Utah, 84103
Shriners Children's Spokane
Spokane, Washington, 99204
About this study
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.
Read the 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.
- Conditions
- Idiopathic Toe Walking
- Being tested
- Surgery, Serial Casting
- Keywords
- Idiopathic Toe Walking, Gait, Casting, Surgery, Genomics, Motor Control, Strength, Balance and Coordination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Surgical procedure to the gastrocnemius and/or plantar fascia
Serial CastingProcedure or surgery
Repeated casts weekly until desired dorsiflexion range achieved
| Study group | Role | What they receive |
|---|---|---|
| Serial Casting | Active comparator | Repeated casts weekly until desired dorsiflexion range achieved Receives: Procedure: Serial Casting |
| Surgery | Active comparator | Surgical procedure to the gastrocnemius and/or plantar fascia Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait parameters: Velocity
Velocity (m/s) will be assessed during walking in the gait lab.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months post intervention, 1 year post intervention
Secondary outcomes (2)
Passive Range of Motion
Dorsiflexion with and without knee flexion, popliteal angle are measured with a goniometer and measured in degrees
Measured: Baseline, 6 months post intervention, 1 year post intervention
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.
Measured: Baseline, 6 months post intervention, 1 year post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Toe WalkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Bauer, Shriners Hospitals for Children
- Investigators
- Jeremy Bauer, MD, Principal investigator, Shriners Hospitals for Children-Portland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305689
- Sponsor's protocol ID
- 79144
- Acronym
- ITW
- Status last verified
- Jul 2024
- First submitted
- 20 Nov 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking*
- ClinicalTrials.gov ID
- NCT06305689
- Acronym / sponsor ID
- ITW / 79144
- Conditions
- Idiopathic Toe Walking
- Keywords
- Idiopathic Toe Walking, Gait, Casting, Surgery, Genomics, Motor Control, Strength, Balance and Coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serial Casting | Active comparator | Procedure: Serial CastingRepeated casts weekly until desired dorsiflexion range achieved |
| Surgery | Active comparator | Procedure: SurgerySurgical procedure to the gastrocnemius and/or plantar fascia |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgerySurgical procedure to the gastrocnemius and/or plantar fascia | Procedure or surgery | Surgery |
| Serial CastingRepeated casts weekly until desired dorsiflexion range achieved | Procedure or surgery | Serial Casting |
Primary outcome
Gait parameters: Velocity
Time frame: Baseline, 6 months post intervention, 1 year post intervention
Velocity (m/s) will be assessed during walking in the gait lab.
Gait Parameters:Stride Length (m)
Time frame: Baseline, 6 months post intervention, 1 year post intervention
Stride Length (m) will be assessed during walking in the gait lab.
Three dimensional Gait Analysis:Kinematics (degrees)
Time frame: Baseline, 6 months post intervention, 1 year post intervention
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.
Dynamic Motor Control Index during Walking (Walk-DMC)
Time frame: Baseline, 6 months post intervention, 1 year post intervention
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)
Three dimensional Gait Analysis:Kinetics (nm/kg)
Time frame: Baseline, 6 months post intervention, 1 year post intervention
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.
Quantitative Assessment of Toe Walking
Time frame: Baseline, 6 months post intervention, 1 year post intervention
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.
Pediatric Outcomes Data Collection Instrument
Time frame: Baseline, 6 months post intervention, 1 year post intervention
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.
2 secondary outcomes
Passive Range of Motion
Time frame: Baseline, 6 months post intervention, 1 year post intervention
Muscle Strength
Time frame: Baseline, 6 months post intervention, 1 year post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Toe Walking
Recruiting
The Effect of Targeting the Plantaris Muscle-tendon in Surgical Correction of Ankle Equinus in Children
Idiopathic Toe Walking, Cerebral Palsy
Recruiting
A Needle Technique for Achilles Tendon Lengthening in Pediatric Patients: A Prospective Study on Efficacy, Safety, and Feasibility
Equinus Contracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Bauer, MD principal investigator
Shriners Hospitals for Children-Portland
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and Serial Casting in people with Idiopathic Toe Walking, run by Shriners Hospitals for Children at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait parameters: Velocity (time frame: Baseline, 6 months post intervention, 1 year post intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.