Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT07163520
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2025-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Elastographic Assessment of Gastrocnemius Muscle Structure in Children With Idiopathic Toe Walking
Sponsor:
Fatih Sultan Mehmet Training and Research Hospital
Organization:
Study Overview
Official Title:
Shear-Wave Elastography Evaluation of the Gastrocnemius Muscle in Children With Idiopathic Toe Walking Compared to Typically Developing Peers
Status:
COMPLETED
Status Verified Date:
2025-09
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:
None
Brief 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 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.
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.
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 Oversight
Has Oversight DMC:
False
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?: