Effects of Reformer Pilates and Vestibular Exercise Programs on Balance and Gait in Children With Visual Impairment
31 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
75
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Istanbul
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Istanbul, Istanbul, Turquia (Türkiye)
- Türkan Sabancı Görme Engelliler Okulu
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Static Balance Performance: Center of Pressure Sway Area
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Muscle Strength: Isometric Knee Extensor Muscle Strength
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Selda Uzun, PhD, Marmara University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
14 de fevereiro de 2025
Conclusão Primária (Estimado)
30 de novembro de 2026
Conclusão do estudo (Estimado)
25 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
24 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de agosto de 2026
Primeira postagem (Real)
27 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MARMARA-VI-RP-2026-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .