Effects of Reformer Pilates and Vestibular Exercise Programs on Balance and Gait in Children With Visual Impairment
31 de agosto de 2026 actualizado por: Marmara University
Effects of Different Exercise Programs on Balance Performance and Gait Biomechanics in Children With Visual Impairment
This study looks at whether Reformer Pilates can help children and adolescents with visual impairment improve their balance, walking patterns, and muscle strength.
Participants are between 10 and 17 years old. They are randomly placed into one of two groups: an exercise group or a control group.
Those in the exercise group take part in 12 supervised Reformer Pilates sessions over 6 weeks, meeting twice a week. Those in the control group keep up with their usual daily activities and do not join the exercise program during this time.
Before and after the 6-week period, researchers measure each participant's balance, walking patterns, and muscle strength. They then compare how much each group changed.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
75
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
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Istanbul
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Istanbul, Istanbul, Turquía (Türkiye)
- Türkan Sabancı Görme Engelliler Okulu
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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:
- Children and adolescents aged 10 to 17 years
- Diagnosis of visual impairment, classified as degree 2 to 5
- informed consent provided by a parent or legal guardian
Exclusion Criteria:
- Presence of an orthopedic disorder affecting balance, gait, or participation in the exercise program
- Presence of a neurological disorder affecting balance, gait, or participation in the exercise program
- Use of medications known to affect balance or gait
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Pilates (Equipment-Based Pilates(Reformer)) Group
Participants in this arm received a supervised Reformer Pilates exercise program twice weekly for 6 weeks, for a total of 12 sessions
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Participants in this arm attended a supervised Reformer Pilates program, held twice a week for six weeks (12 sessions in total).
Sessions were structured around the Reformer apparatus and followed a progressive format, with exercise difficulty gradually increasing as participants advanced through the program.
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Experimental: Vestibular Exercise Group
Participants in this group receive a supervised vestibular balance exercise program for 6 weeks, consisting of 12 sessions (two sessions per week).
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Participants in this arm attended a supervised vestibular balance exercise program, held twice a week for six weeks (12 sessions in total).
Exercises were performed under varying sensory conditions and progressed in difficulty as participants advanced through the program.
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Sin intervención: Control Group
Participants in this arm continued their usual daily activities and did not receive either of the study exercise programs during the study period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Static Balance Performance: Center of Pressure Sway Area
Periodo de tiempo: Baseline and post-intervention at Week 6
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Center of Pressure Sway Area: Static balance performance is assessed using the TekScan pressure platform.
Center of pressure (COP) sway area is measured during standardized quiet standing and expressed in square centimeters (cm²) and Higher values indicate greater postural sway.
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Baseline and post-intervention at Week 6
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Static Balance Performance: Center of Pressure Path Length
Periodo de tiempo: Baseline and post-intervention at Week 6
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Center of pressure path length is measured using the TekScan pressure platform during quiet standing, representing the total displacement distance of the center of pressure, expressed in centimeters (cm).
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Baseline and post-intervention at Week 6
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Static Balance Performance: Antero-posterior Center of Pressure Excursion
Periodo de tiempo: Baseline and post-intervention at Week 6
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Anteroposterior center of pressure excursion is measured using the TekScan pressure platform during quiet standing, representing postural sway in the forward-backward direction, expressed in centimeters (cm).
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Baseline and post-intervention at Week 6
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Static Balance Performance: Mediolateral Center of Pressure Excursion
Periodo de tiempo: Baseline and post-intervention at Week 6
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Medio-lateral center of pressure excursion is measured using the TekScan pressure platform during quiet standing, representing postural sway in the side-to-side direction, expressed in centimeters (cm).
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Baseline and post-intervention at Week 6
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Gait - Spatiotemporal:Walking Speed
Periodo de tiempo: Baseline and post-intervention at Week 6
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Walking speed is assessed using the iSen Inertial Motion Capture System by STT Systems (iSEN IMUs )during the walking test and it is expressed in meters per second (m/s).
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Baseline and post-intervention at Week 6
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Gait - Spatiotemporal: Gait Cadence
Periodo de tiempo: Baseline and post-intervention at Week 6
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Gait cadence is assessed using the iSen IMUs and it represents the average number of steps taken per minute during walking.
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Baseline and post-intervention at Week 6
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Gait - Spatiotemporal: Step Length and Stride Length During Gait
Periodo de tiempo: Baseline and post-intervention at Week 6
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Step length and stride length are assessed using the iSEN IMU system during walking, expressed in meters (m).
Step length represents the average distance between consecutive foot contacts of opposite feet and stride length represents the average distance between successive contacts of the same foot.
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Baseline and post-intervention at Week 6
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Pelvic Symmetry
Periodo de tiempo: Baseline and post-intervention at Week 6
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Pelvic symmetry during gait is assessed using the iSEN IMUs and it is expressed as a percentage (%).
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Baseline and post-intervention at Week 6
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Gait: Stance and Swing Phase Duration
Periodo de tiempo: Baseline and post-intervention at Week 6
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During Gait Stance and swing phase durations are assessed bilaterally using the iSEN IMUs.
Stance phase represents the portion of the gait cycle during which the foot is in contact with the ground, and swing phase represents the portion during which the foot is not in contact with the ground.
Values are recorded separately for the right and left limbs, expressed in seconds and as a percentage of the gait cycle.
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Baseline and post-intervention at Week 6
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Gait: Double Support Duration During Gait
Periodo de tiempo: Baseline and post-intervention at Week 6
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Double support duration is assessed bilaterally using iSEN IMUs and represents the portion of the gait cycle during which both feet are concurrently in contact with the ground.
Values are recorded separately for the right and left limbs, expressed as a percentage of the gait cycle.
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Baseline and post-intervention at Week 6
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Gait Kinematics: Hip Flexion-Extension Angle During Gait
Periodo de tiempo: Baseline and post-intervention at Week 6
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Hip flexion and extension angles during the gait cycle are assessed bilaterally using the iSEN IMUs and expressed in degrees (º).
Maximum hip flexion angle and minimum hip extension angle are recorded separately for the right and left limbs.
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Baseline and post-intervention at Week 6
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Gait Kinematics: Hip Flexion-Extension Range of Motion During Gait
Periodo de tiempo: Baseline and post-intervention at Week 6
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Hip flexion-extension range of motion during the gait cycle is assessed bilaterally using the iSEN IMUs and expressed in degrees (º),it is recorded separately for the right and left limbs.
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Baseline and post-intervention at Week 6
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Gait Kinematics: Knee Flexion-Extension Angle During Gait
Periodo de tiempo: Baseline and post-intervention at Week 6
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Knee flexion and extension angles during the gait cycle are assessed bilaterally using the iSEN IMUs and expressed in degrees (º).
Maximum knee flexion angle and minimum knee extension angle are recorded separately for the right and left limbs.
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Baseline and post-intervention at Week 6
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Gait Kinematics: Knee Flexion-Extension Range of Motion During Gait
Periodo de tiempo: Baseline and post-intervention at Week 6
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Knee flexion-extension range of motion during the gait cycle is assessed bilaterally using the iSEN IMUs and expressed in degrees (º), recorded separately for the right and left limbs.
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Baseline and post-intervention at Week 6
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Gait Kinematics: Ankle Dorsiflexion-Plantarflexion Angle During Gait
Periodo de tiempo: Baseline and post-intervention at Week 6
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Ankle dorsiflexion and plantarflexion angles during the gait cycle are assessed bilaterally using the iSEN IMUs and expressed in degrees (º).
Maximum dorsiflexion angle and minimum plantarflexion angle are recorded separately for the right and left limbs.
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Baseline and post-intervention at Week 6
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Gait Kinematics: Ankle Dorsiflexion-Plantarflexion Range of Motion During Gait
Periodo de tiempo: Baseline and post-intervention at Week 6
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Ankle dorsiflexion-plantarflexion range of motion during the gait cycle is assessed bilaterally using the iSEN IMUs system and expressed in degrees (º), it is recorded separately for the right and left limbs.
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Baseline and post-intervention at Week 6
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Gait Kinematics: Pelvic Tilt Angle During Gait
Periodo de tiempo: Baseline and post-intervention at Week 6
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Maximum posterior and anterior pelvic tilt angles during the gait cycle are assessed using the iSEN IMUs inertial measurement unit system and expressed in degrees (º), recorded separately as posterior tilt and anterior tilt values.
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Baseline and post-intervention at Week 6
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Gait Kinematics: Pelvic Tilt Range of Motion
Periodo de tiempo: Baseline and post-intervention at Week 6
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Pelvic tilt range of motion during the gait cycle is assessed using the iSEN IMUs , representing the combined anterior (posterior tilt) and interior (anterior tilt) excursion, expressed in degrees (º).
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Baseline and post-intervention at Week 6
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Muscle Strength: Isometric Knee Extensor Muscle Strength
Periodo de tiempo: Baseline and post-intervention at Week 6
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Knee Extension Isometric Strength Assessment: Participants will sit with knees at ~90° flexion, feet unsupported, distal posterior thigh positioned ~10 cm from the chair's front edge, arms on the armrests with hands gripping the handles, and thighs/pelvis stabilized with a strap.
A dynamometer will be fixed to an apparatus mounted behind the chair using a rigid, non-stretch strap positioned ~2 cm proximal to the lateral malleolus and secured across the anterior tibial surface; participants will perform knee extension, applying maximal isometric force against the dynamometer through the strap.
Three 5-second maximal contractions will be performed, with 1-minute rest between trials and verbal encouragement to ensure maximal effort; peak force will be recorded for each trial.
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Baseline and post-intervention at Week 6
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Muscle Strength: Isometric Knee Flexor Muscle Strength
Periodo de tiempo: Baseline and post-intervention at Week 6
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Knee Flexion Isometric Strength Assessment: Participants will sit with feet unsupported, arms on the armrests with hands gripping the handles, and popliteal fossa positioned ~10 cm anterior to the chair's front edge, with thighs/pelvis stabilized using a strap.
A dynamometer will be fixed to an apparatus mounted in front of the chair using a rigid, non-stretch strap positioned ~2 cm proximal to the lateral malleolus and secured across the posterior tibial surface; participants will flex the knee to 90° and apply maximal isometric force against the dynamometer through the strap.
Three 5-second maximal contractions will be performed, with 1-minute rest between trials and verbal encouragement to ensure maximal effort; peak force will be recorded for each trial.
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Baseline and post-intervention at Week 6
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Trunk Muscle Endurance: Trunk Flexor Endurance
Periodo de tiempo: Baseline and post-intervention at Week 6
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Trunk flexor endurance is assessed using a 1-minute curl-up test.
Participants perform repeated curl-ups from a supine position with knees flexed at 90°, sliding their hands forward toward the knees and returning to the starting position with proper form.
The number of correctly completed repetitions within 1 minute is recorded.
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Baseline and post-intervention at Week 6
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Trunk Extensor Endurance
Periodo de tiempo: Baseline and post-intervention at Week 6
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Description: Trunk extensor endurance is assessed using a modified Sørensen test performed on a Roman chair, with the pelvis and lower extremities secured.
Participants cross their arms over the chest and maintain the trunk horizontally aligned with the lower extremities, knees extended, for as long as possible.
The test is terminated when the participant can no longer sustain the position, and the duration is recorded in seconds.
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Baseline and post-intervention at Week 6
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Selda Uzun, PhD, Marmara University
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)
14 de febrero de 2025
Finalización primaria (Estimado)
30 de noviembre de 2026
Finalización del estudio (Estimado)
25 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
24 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de agosto de 2026
Publicado por primera vez (Actual)
27 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MARMARA-VI-RP-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be made available to other researchers.
Because the study population consists of children, data sharing is restricted in line with the permission obtained from the Provincial Directorate of National Education.
Study results will only be presented in aggregate form, without any information that could identify individual participants.
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
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .