Idiopathic Toe-walkingNCT07163520
Elastographic Assessment of Gastrocnemius Muscle Structure in Children With Idiopathic Toe Walking
An observational study of Idiopathic Toe-walking, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Idiopathic toe walking (ITW) is a gait pattern characterized by the absence of heel strike during the stance phase and incomplete foot contact with the ground. After excluding neurological, neuromuscular, and orthopedic causes such as cerebral palsy, neuropathies, myopathies, and spinal dysraphism, the diagnosis of… Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Toe-walking
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 15 May 2025
- Phase
- Observational
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 4 to 12 years diagnosed with bilateral idiopathic toe walking and healthy age-matched controls.
Who may be able to join
- Children aged 4 to 12 years with a bilateral idiopathic toe walking pattern Absence of neurological, orthopedic, or psychiatric conditions that could explain the toe walking gait pattern (e.g., cerebral palsy, myopathies, autism spectrum disorders, developmental disorders, neuropathies) Healthy volunteers matched for age and sex (for control group) Child and parent/guardian who were willing to participate in the study and provided written informed consent.
- -
- Exclusion Criteria:Presence of neurological, orthopedic, or psychiatric conditions that could explain the toe walking gait pattern (e.g., cerebral palsy, myopathies, autism spectrum disorders, developmental disorders, neuropathies)
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Istanbul
About this study
Official title: Shear-Wave Elastography Evaluation of the Gastrocnemius Muscle in Children With Idiopathic Toe Walking Compared to Typically Developing Peers
Idiopathic toe walking (ITW) is a gait pattern characterized by the absence of heel strike during the stance phase and incomplete foot contact with the ground. After excluding neurological, neuromuscular, and orthopedic causes such as cerebral palsy, neuropathies, myopathies, and spinal dysraphism, the diagnosis of ITW can be established. Although alterations in muscle histology and architecture have been reported in children with ITW, radiological evaluation of the musculoskeletal system remains limited.
Shear Wave Elastography (SWE) is a non-invasive, objective, and cost-effective imaging technique that quantitatively assesses tissue stiffness by measuring shear wave velocity and elasticity.
The present study aims to evaluate gastrocnemius muscle and Achilles tendon elasticity in children with ITW compared with age-matched healthy controls. By combining SWE measurements with clinical assessments-including ankle dorsiflexion range of motion, Toe Walking Severity Scale, Foot Posture Index, and a functionality questionnaire-we aim to better characterize the musculoskeletal alterations associated with ITW.
Read the detailed description
In some children, the inability to perform heel strike may lead to toe walking. Toe walking can occur due to a variety of conditions, including cerebral palsy, spina bifida, muscular dystrophies, limb-length discrepancies, and autism spectrum disorders. When no underlying medical cause is identified, the diagnosis of idiopathic toe walking (ITW) is made. ITW is a diagnosis of exclusion.
The etiology of ITW remains unclear. A positive family history of toe walking has been frequently reported, suggesting a potential genetic component. Sensory integration deficits have also been proposed as a contributing factor. Muscle biopsy studies have shown an increased proportion of type I fibers in children with ITW compared to typically developing peers. Toe walking leads to remodeling of the muscle-tendon unit. A study using ultrasonography (US), isokinetic dynamometry, and surface electromyography have demonstrated that the gastrocnemius (GC) muscle and its fascicles are longer and the Achilles tendon is shorter in children with ITW compared to healthy controls.
Rehabilitation strategies such as stretching, strengthening, and spasticity management aim to improve the biomechanical properties of the muscle. Investigating biomechanical characteristics, including muscle stiffness, is essential for understanding musculoskeletal adaptations.
Non-invasive techniques are particularly preferred in the pediatric population. Shear-Wave Elastography (SWE) is a non-invasive, cost-effective, and objective method for evaluating tissue stiffness in vivo, with promising clinical applications in the musculoskeletal system. While SWE has been applied in pediatric neuromuscular conditions, data on musculoskeletal imaging in children with ITW remain limited. Few studies have evaluated this population using ultrasonography and none have directly compared ITW children with healthy controls using SWE.
Evaluating differences between children with ITW and their typically developing peers may enhance understanding of this poorly understood gait pattern and support the development of more effective treatment approaches. The aim of this study is to assess the structure of the medial gastrocnemius muscle and Achilles tendon in children with ITW using SWE, comparing the results with a healthy control group. This approach will allow comprehensive evaluation of clinical parameters and musculoskeletal characteristics in this children.
- Conditions
- Idiopathic Toe-walking
- Keywords
- idiopathic toe-walking, shear wave elastography, gastrocnemius, achilles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Toe Walking Group | Children aged 4 to 12 years with bilateral idiopathic toe-walking pattern, defined as toe-walking gait in the absence of any underlying neurological, orthopedic, or psychiatric conditions (such as cerebral palsy, muscular dystrophies, neuropathies, autism spectrum disorder, or developmental delay). | |
| Healthy Control Group | Age- and sex-matched typically developing children without a history of toe-walking or any neurological, orthopedic, or psychiatric disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elastography measurements (kPa) of the gastrocnemius muscle and Achilles tendon in children with idiopathic toe walking compared to healthy controls
The gastrocnemius is a biarticular muscle, and its stiffness may be influenced by ankle dorsiflexion and plantarflexion. In the present study, all measurements were performed with the child in the prone position. In children with idiopathic toe walking, both lower extremities were evaluated with the knees extended and the feet hanging off the examination table. Tissue elasticity (kPa) was measured from the medial gastrocnemius and Achilles tendon in three different ankle positions: neutral, passive dorsiflexion, and passive plantarflexion. For each region of interest, five measurements were obtained and averaged.Gastrocnemius muscle and Achilles tendon length was also recorded. For the control group, the same measurements were performed on the dominant lower extremity. The dominant leg was determined by asking the child which foot they would use to kick a ball.
Measured: At study visit (baseline, cross-sectional)
Secondary outcomes (4)
Passive and active ankle dorsiflexion angles measured with a manual goniometer in knee flexion and extension
Bilateral passive and active ankle dorsiflexion angles are measured by using a manual goniometer with the knee positioned in both flexion and extension by the same clinician each time, for both groups
Measured: At study visit (baseline, cross-sectional)
Toe Walking Severity Scale
The Toe Walking Severity Scale is used to evaluate the severity of idiopathic toe walking in children. Parents were asked how often their child walks on toes during the day.
Measured: At study visit (baseline, cross-sectional)
Foot Posture Index
The Foot Posture Index (FPI) was used to evaluate the alignment of the feet and anatomical segments. The FPI, based on the scoring of six different criteria, provided information on whether the foot posture was pronated, neutral, or supinated. The Foot Posture Index scores of children with idiopathic toe walking (ITW) and those in the control group were also compared.
Measured: At study visit (baseline, cross-sectional)
The Pediatric Outcomes Data Collection Instrument
The Pediatric Outcomes Data Collection Instrument (PODCI), a parent-reported questionnaire consisting of 86 items, was used to assess the child's functional status. The two groups were also compared using this instrument.
Measured: At study visit (baseline, cross-sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Oct 2024
- Primary completion15 Apr 2025
- Study completion15 May 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sude Gözüküçük Türkyılmaz, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163520
- Sponsor's protocol ID
- ITW-SWE
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shear-Wave Elastography Evaluation of the Gastrocnemius Muscle in Children With Idiopathic Toe Walking Compared to Typically Developing Peers
- ClinicalTrials.gov ID
- NCT07163520
- Acronym / sponsor ID
- ITW-SWE
- Conditions
- Idiopathic Toe-walking
- Keywords
- idiopathic toe-walking, shear wave elastography, gastrocnemius, achilles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 9 Sep 2025 (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.
Idiopathic toe walking (ITW) is a gait pattern characterized by the absence of heel strike during the stance phase and incomplete foot contact with the ground. After excluding neurological, neuromuscular, and orthopedic causes such as cerebral palsy, neuropathies, myopathies, and spinal dysraphism, the diagnosis of ITW can be established. Although alterations in muscle histology and architecture have been reported in children with ITW, radiological evaluation of the musculoskeletal system remains limited.
Shear Wave Elastography (SWE) is a non-invasive, objective, and cost-effective imaging technique that quantitatively assesses tissue stiffness by measuring shear wave velocity and elasticity.
The present study aims to evaluate gastrocnemius muscle and Achilles tendon elasticity in children with ITW compared with age-matched healthy controls. By combining SWE measurements with clinical assessments-including ankle dorsiflexion range of motion, Toe Walking Severity Scale, Foot Posture Index, and a functionality questionnaire-we aim to better characterize the musculoskeletal alterations associated with ITW.
Detailed description
In some children, the inability to perform heel strike may lead to toe walking. Toe walking can occur due to a variety of conditions, including cerebral palsy, spina bifida, muscular dystrophies, limb-length discrepancies, and autism spectrum disorders. When no underlying medical cause is identified, the diagnosis of idiopathic toe walking (ITW) is made. ITW is a diagnosis of exclusion.
The etiology of ITW remains unclear. A positive family history of toe walking has been frequently reported, suggesting a potential genetic component. Sensory integration deficits have also been proposed as a contributing factor. Muscle biopsy studies have shown an increased proportion of type I fibers in children with ITW compared to typically developing peers. Toe walking leads to remodeling of the muscle-tendon unit. A study using ultrasonography (US), isokinetic dynamometry, and surface electromyography have demonstrated that the gastrocnemius (GC) muscle and its fascicles are longer and the Achilles tendon is shorter in children with ITW compared to healthy controls.
Rehabilitation strategies such as stretching, strengthening, and spasticity management aim to improve the biomechanical properties of the muscle. Investigating biomechanical characteristics, including muscle stiffness, is essential for understanding musculoskeletal adaptations.
Non-invasive techniques are particularly preferred in the pediatric population. Shear-Wave Elastography (SWE) is a non-invasive, cost-effective, and objective method for evaluating tissue stiffness in vivo, with promising clinical applications in the musculoskeletal system. While SWE has been applied in pediatric neuromuscular conditions, data on musculoskeletal imaging in children with ITW remain limited. Few studies have evaluated this population using ultrasonography and none have directly compared ITW children with healthy controls using SWE.
Evaluating differences between children with ITW and their typically developing peers may enhance understanding of this poorly understood gait pattern and support the development of more effective treatment approaches. The aim of this study is to assess the structure of the medial gastrocnemius muscle and Achilles tendon in children with ITW using SWE, comparing the results with a healthy control group. This approach will allow comprehensive evaluation of clinical parameters and musculoskeletal characteristics in this children.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Toe Walking Group | – | –Children aged 4 to 12 years with bilateral idiopathic toe-walking pattern, defined as toe-walking gait in the absence of any underlying neurological, orthopedic, or psychiatric conditions (such as cerebral palsy, muscular dystrophies, neuropathies, autism spectrum disorder, or developmental delay). |
| Healthy Control Group | – | –Age- and sex-matched typically developing children without a history of toe-walking or any neurological, orthopedic, or psychiatric disorders. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 4 to 12 years diagnosed with bilateral idiopathic toe walking and healthy age-matched controls.
Key inclusion criteria (4 listed)
- Children aged 4 to 12 years with a bilateral idiopathic toe walking pattern Absence of neurological, orthopedic, or psychiatric conditions that could explain the toe walking gait pattern (e.g., cerebral palsy, myopathies, autism spectrum disorders, developmental disorders, neuropathies) Healthy volunteers matched for age and sex (for control group) Child and parent/guardian who were willing to participate in the study and provided written informed consent.
- -
- Exclusion Criteria:Presence of neurological, orthopedic, or psychiatric conditions that could explain the toe walking gait pattern (e.g., cerebral palsy, myopathies, autism spectrum disorders, developmental disorders, neuropathies)
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Elastography measurements (kPa) of the gastrocnemius muscle and Achilles tendon in children with idiopathic toe walking compared to healthy controls
Time frame: At study visit (baseline, cross-sectional)
The gastrocnemius is a biarticular muscle, and its stiffness may be influenced by ankle dorsiflexion and plantarflexion. In the present study, all measurements were performed with the child in the prone position. In children with idiopathic toe walking, both lower extremities were evaluated with the knees extended and the feet hanging off the examination table. Tissue elasticity (kPa) was measured from the medial gastrocnemius and Achilles tendon in three different ankle positions: neutral, passive dorsiflexion, and passive plantarflexion. For each region of interest, five measurements were obtained and averaged.Gastrocnemius muscle and Achilles tendon length was also recorded. For the control group, the same measurements were performed on the dominant lower extremity. The dominant leg was determined by asking the child which foot they would use to kick a ball.
4 secondary outcomes
Passive and active ankle dorsiflexion angles measured with a manual goniometer in knee flexion and extension
Time frame: At study visit (baseline, cross-sectional)
Toe Walking Severity Scale
Time frame: At study visit (baseline, cross-sectional)
Foot Posture Index
Time frame: At study visit (baseline, cross-sectional)
The Pediatric Outcomes Data Collection Instrument
Time frame: At study visit (baseline, cross-sectional)
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 9 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Toe-walking, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 0 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 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Elastography measurements (kPa) of the gastrocnemius muscle and Achilles tendon in children with idiopathic toe walking compared to healthy controls (time frame: At study visit (baseline, cross-sectional)). 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 9 Sep 2025.