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Effects of Custom Fitted Supportive Socks With Integrated Insoles in Individuals With Flat Feet

26 de junio de 2026 actualizado por: Ibadat International University, Islamabad

The goal of this clinical trial is to test if wearing custom-fitted supportive socks with built-in insoles, along with a foot exercise program, can improve foot posture, The goal of this clinical trial is to evaluate whether wearing custom-fitted supportive socks with built-in insoles, along with a foot exercise program, can improve foot posture, walking ability, and foot comfort in children aged five to twelve years with flexible flat feet.

The main questions this study aims to answer are:

Does the use of supportive socks with insoles and exercises improve foot posture and the shape of the foot arch? Does this combined approach improve walking ability and overall foot comfort? Researchers will compare children who wear supportive socks with built-in insoles and perform exercises to children who perform the same exercise program without the supportive socks to see which approach is more effective.

Participants will:

Wear the assigned supportive socks for 6-8 hours each day during daily activities if allocated to the socks group.

Perform foot exercises with a physical therapist for six weeks. Take part in assessments of foot posture, walking ability, and foot comfort at the start and after six weeks Data collection is currently in progress. The findings of this study may help support non-surgical treatment options for children with flexible flat feet.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This randomized controlled trial is being conducted to evaluate the effectiveness of custom-fitted supportive socks with integrated insoles combined with a comprehensive exercise program in individuals with flexible flat feet. Participants are being randomly allocated into two groups: the intervention group receives both the supportive socks with integrated insoles and an exercise program, while the control group receives the exercise program alone. The primary aim of the study is to determine the intervention's impact on postural alignment, functional mobility, and foot health. A single-blind design is being employed, with the outcome assessor blinded to group allocation. This trial aims to generate evidence regarding the use of custom-fitted supportive socks with integrated insoles in conjunction with exercises for the conservative management of flexible flat feet.

Tipo de estudio

Intervencionista

Inscripción (Actual)

56

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Pakistán
    • Federal
      • Islamabad, Federal, Pakistán
        • Zayneb Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Aged 5 to 12 years
  • Both Gender.
  • With Flexible flat feet.
  • Positive navicular drop test
  • Positive too many toes test, toe raising test and medial longitudinal arch angle

Exclusion Criteria:

  • Any congenital deformity of the lower limb
  • Any recent injuries
  • Any recent surgeries
  • Any neurological deficit
  • Body Mass Index (BMI)≥25

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Insoles with Comprehensive Exercise
Participants in this group received custom-fitted supportive socks with integrated insoles in combination with a supervised comprehensive exercise program. The intervention lasted for 6 weeks, with comprehensive exercises. Insoles were worn for 8 to 10 hours daily.
Dispositivo: Custom fitted supportive socks with integrated insoles
Participants in the intervention group received custom-fitted supportive socks with integrated insoles in addition to a comprehensive foot exercise program. The supportive socks were tailored to individual foot measurements and included insole aimed at correcting postural alignment, functional mobility and improving foot health.
Comparador activo: Comprehensive Exercise Only
Participants in this group received only the comprehensive exercise program, identical in content and supervision to the intervention group and lasted for 6 weeks but without the insoles or supportive socks.
Otro: Comprehensive Exercise Program
Participants received a structured comprehensive exercise program targeting foot intrinsic muscle strengthening, stretching, balance training, and functional mobility. The program duration was 6 weeks and did not include the use of insoles or supportive socks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Navicular Drop Test (NDT)
Periodo de tiempo: Baseline
The Navicular Drop Test assesses postural alignment by measuring the height difference of the navicular bone between the non-weight-bearing and weight-bearing positions. It evaluates medial arch collapse and foot pronation. Higher values = greater navicular drop → poorer postural alignment / more pronation, Lower value = better arch stability.
Baseline
Navicular Drop Test (NDT)
Periodo de tiempo: 6 weeks after intervention
The Navicular Drop Test assesses postural alignment by measuring the height difference of the navicular bone between the non-weight-bearing and weight-bearing positions. It evaluates medial arch collapse and foot pronation. Higher values = greater navicular drop → poorer postural alignment / more pronation, Lower value = better arch stability.
6 weeks after intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Medial Longitudinal Arch Angle (MLAA)
Periodo de tiempo: Baseline

The Medial Longitudinal Arch Angle measures the structural alignment of the foot's medial arch using anatomical landmarks. It is a valid and reliable tool for assessing arch height and foot posture.

Interpretation:

Lower angle = collapsed arch / flat foot Higher angle = better arch height and alignment
Baseline
Medial Longitudinal Arch Angle (MLAA)
Periodo de tiempo: 6 weeks after intervention

The Medial Longitudinal Arch Angle measures the structural alignment of the foot's medial arch using anatomical landmarks. It is a valid and reliable tool for assessing arch height and foot posture.

Interpretation:

Lower angle = collapsed arch / flat foot Higher angle = better arch height and alignment
6 weeks after intervention
Timed Up and Go Test (TUG)
Periodo de tiempo: Baseline

The TUG test evaluates functional mobility by measuring the time it takes for a participant to stand up from a chair, walk 3 meters, turn, walk back, and sit down.

Interpretation:

Lower time = better functional mobility Higher time = decreased mobility or functional limitation
Baseline
Timed Up and Go Test (TUG)
Periodo de tiempo: 6 weeks after intervention

The TUG test evaluates functional mobility by measuring the time it takes for a participant to stand up from a chair, walk 3 meters, turn, walk back, and sit down.

Interpretation:

Lower time = better functional mobility Higher time = decreased mobility or functional limitation
6 weeks after intervention
Six-Minute Walk Test (6MWT)
Periodo de tiempo: Baseline

The 6MWT assesses functional endurance by measuring the total distance a participant can walk in 6 minutes on a flat surface. It reflects lower-limb function and cardiovascular capacity.

Interpretation:

Greater distance = better functional capacity & endurance Shorter distance = lower functional endurance
Baseline
Six-Minute Walk Test (6MWT)
Periodo de tiempo: 6 weeks after intervention

The 6MWT assesses functional endurance by measuring the total distance a participant can walk in 6 minutes on a flat surface. It reflects lower-limb function and cardiovascular capacity.

Interpretation:

Greater distance = better functional capacity & endurance Shorter distance = lower functional endurance
6 weeks after intervention
Foot Function Index (FFI)
Periodo de tiempo: Baseline

The Foot Function Index measures foot pain, disability, and activity limitation using three subscales: Pain (9 items), Disability (9 items), and Activity Limitation (5 items). Each item is scored 0-10 and converted to a percentage.

Interpretation:

Higher score = More pain, disability, and dysfunction Lower score = Better foot function
Baseline
Foot Function Index (FFI)
Periodo de tiempo: 6 weeks after intervention

The Foot Function Index measures foot pain, disability, and activity limitation using three subscales: Pain (9 items), Disability (9 items), and Activity Limitation (5 items). Each item is scored 0-10 and converted to a percentage.

Interpretation:

Higher score = More pain, disability, and dysfunction Lower score = Better foot function
6 weeks after intervention
Foot Health Status Questionnaire (FHSQ)
Periodo de tiempo: Baseline

The FHSQ assesses foot health across four domains: Foot Pain, Foot Function, Footwear, and General Foot Health. Domain scores are transformed to a 0-100 scale.

Interpretation:

Higher scores = Better foot health Lower scores = Poor foot health
Baseline
Foot Health Status Questionnaire (FHSQ)
Periodo de tiempo: 6 weeks after intervention

The FHSQ assesses foot health across four domains: Foot Pain, Foot Function, Footwear, and General Foot Health. Domain scores are transformed to a 0-100 scale.

Interpretation:

Higher scores = Better foot health Lower scores = Poor foot health
6 weeks after intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ibadat International University, Islamabad

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de mayo de 2025

Finalización primaria (Actual)

25 de enero de 2026

Finalización del estudio (Actual)

25 de enero de 2026

Fechas de registro del estudio

Enviado por primera vez

26 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de junio de 2026

Publicado por primera vez (Actual)

2 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de junio de 2026

Última verificación

1 de mayo de 2025

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IIUI/RERC/ADT/2025/04/178

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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