- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07632924
Medial Arch-Support Wrestling Shoes and Foot Posture Preservation in Adolescent Wrestlers (MAWS-RCT)
Medial Arch-Support Wrestling Shoes and Foot Posture Preservation in Adolescent Wrestlers: A Three-Year Randomized Controlled Trial
This three-year randomized controlled trial investigated whether wrestling shoes with built-in medial arch support can preserve foot arch structure in adolescent male wrestlers compared to standard wrestling shoes without arch support.
A total of 88 adolescent male wrestlers (age 11 at baseline) were randomly assigned to wear either modified wrestling shoes with integrated medial arch support (intervention group, n=44) or standard commercially available wrestling shoes (control group, n=44). Foot posture was assessed annually using the Staheli Arch Index via podoscopy. Plantar pressure distribution was recorded using the Tekscan F-Scan system. The study followed participants for three years.
The primary aim was to determine whether medial arch-support wrestling shoes reduce the emergence of flat foot (pes planus) compared with standard wrestling shoes during a critical period of foot development in young athletes.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Malatya, Turquía (Türkiye)
- Regional Boarding School (YBO)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Registered wrestlers at Regional Boarding Schools (YBO)
- Training frequency of 3 or more days per week
- No lower extremity injury within the preceding 6 months
- No current orthopedic insole use
- Normal foot posture at baseline
Exclusion Criteria:
- Prior lower extremity surgery
- Neurological disorders
- Rheumatological disorders
- Severe congenital foot deformity
- Current orthopedic insole use
- Existing foot deformity at baseline
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Modified Wrestling Shoe (Arch Support)
Participants wore modified wrestling shoes with integrated medial arch support, multi-density rubber outsole, reinforced heel stabilization, structured midfoot midsole, and optimized plantar contact geometry for three years during all wrestling training sessions.
Shoe sizes were monitored and replaced as needed.
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Modified wrestling shoe incorporating a multi-density rubber outsole, integrated medial longitudinal arch support, reinforced heel stabilization with hidden heel pads, structured midfoot midsole, four-way stretch Scuba fabric upper, and adhesive Velcro tape closure system.
Designed to redistribute plantar pressure and preserve medial longitudinal arch structure during wrestling training.
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Comparador activo: Standard Wrestling Shoe
Participants wore standard commercially available wrestling shoes featuring a flat thin rubber outsole, no cushioning midsole, no arch support, near-zero heel drop, and a high collar for three years during all wrestling training sessions.
Shoe sizes were monitored and replaced as needed.
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Conventional commercially available wrestling shoe featuring a thin flat rubber outsole, hard insole without arch support, tight lacing system, high collar, and rigid non-flexible plastic base.
No medial arch support or plantar load redistribution features.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Foot Posture Classification (Staheli Arch Index)
Periodo de tiempo: Baseline, Year 1, Year 2, Year 3
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Foot posture was classified annually using the Staheli Arch Index (SAI) assessed via podoscopy.
Classifications: normal (SAI 0.45-0.89),
flexible pes planus (SAI 0.90-1.00),
and rigid pes planus (SAI ≥1.01, confirmed by Jack Toe Raise Test).
Between-group differences were evaluated using Fisher's exact test with Bonferroni correction.
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Baseline, Year 1, Year 2, Year 3
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Plantar Pressure Distribution
Periodo de tiempo: Year 3
|
Dynamic plantar pressure distribution was recorded using the Tekscan F-Scan system (3000E sensors, 100 Hz) during 30-second walking trials on a UWW-approved mat.
Pressure maps were evaluated qualitatively for midfoot contact area and center of pressure trajectory.
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Year 3
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Standing Height
Periodo de tiempo: Baseline, Year 1, Year 2
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Standing height (cm) was measured using a calibrated stadiometer at each assessment point.
Between-group differences were analyzed using mixed-design ANOVA (group × time).
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Baseline, Year 1, Year 2
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Body Mass
Periodo de tiempo: Baseline, Year 1, Year 2
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Body mass (kg) was measured using a calibrated scale at each assessment point.
Between-group differences were analyzed using mixed-design ANOVA (group × time).
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Baseline, Year 1, Year 2
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mahmut Açak, Çanakkale Onsekiz Mart University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Pies
- Enfermedades musculoesqueléticas
- Anomalías musculoesqueléticas
- Anomalías congénitas
- Deformidades Congénitas De Las Extremidades Inferiores
- Deformidades de las extremidades, congénitas
- Deformidades del pie, adquiridas
- Deformidades Congénitas Del Pie
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Deformidades del pie
- Pie plano
Otros números de identificación del estudio
- 2018-106
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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