- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07718282
Acute Effects of Oculomotor Exercises on Posturography and Gait Analysis Parameters in Regular Exercisers (OMEX-PG)
The Acute Effects of Oculomotor Exercises on Static Posturography and Gait Analysis Parameters in Regular Exercisers
This study aims to investigate the acute effects of a single-session oculomotor exercise program on static posturography and gait analysis parameters in healthy individuals who exercise regularly. Postural control and gait are complex sensorimotor functions that depend on the integration of visual, vestibular, somatosensory, and motor systems. Eye movements and gaze stabilization may contribute to postural orientation and locomotor control by influencing visual-vestibular integration, head-eye coordination, and sensorimotor adaptation. However, the immediate effects of short-duration oculomotor exercise programs on postural sway and gait-related parameters in regular exercisers have not been fully clarified.
This study is designed as a single-group, within-session, pre-post interventional study. Participants will undergo baseline assessments, complete a single session of oculomotor exercises, and then be reassessed after the intervention in the same testing session. The study population will consist of healthy adults who exercise regularly and meet the predefined eligibility criteria. Individuals with musculoskeletal injury, neurological or vestibular disorders, visual conditions that may affect balance or eye movement performance, or any condition limiting participation in the testing procedures will be excluded.
Static posturography will be performed using the HUR SmartBalance BTG4 system to evaluate postural sway under different sensory conditions. Measurements will be obtained during quiet standing with eyes open on a firm surface, eyes closed on a firm surface, eyes open on a foam surface, and eyes closed on a foam surface. The main posturography variables will include sway area, trace length, sway velocity, lateral sway, and anterior-posterior sway.
Gait analysis will be performed before and after the intervention using the DIERS Pedogait system. Spatiotemporal, phase-related, and center-of-pressure-based gait parameters will be recorded. These parameters may include step length, stride length, step time, stride time, track width, cadence, stance phase, swing phase, double support, pre-swing, and center-of-pressure-related gait variables.
The oculomotor exercise program will include three main components: extraocular eye movement exercises, vestibulo-ocular and cervico-ocular gaze stabilization exercises, and accommodation exercises. During extraocular eye movement exercises, participants will be asked to follow a visual target with eye movements while keeping the head stable. During gaze stabilization exercises, participants will maintain visual fixation on a target while performing controlled head movements and walking steps. During accommodation exercises, participants will alternate focus between a near target and a distant target. The exercises will be performed at different speeds to stimulate oculomotor control, gaze stabilization, and visual focusing mechanisms.
The primary outcome of the study is the change in sway area from baseline to the post-intervention assessment. Secondary outcomes include changes in other static posturography parameters and gait analysis variables. By evaluating both postural sway and gait-related outcomes, this study aims to provide preliminary evidence on whether a short oculomotor exercise session may produce immediate changes in postural control and walking characteristics in regular exercisers.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Bornova
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Izmir, Bornova, Turquía (Türkiye), 35100
- Ege University Faculty of Medicine, Department of Sports Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Healthy adults aged 18 to 50 years
- Regular participation in exercise
- Ability to walk independently without an assistive device
- Ability to understand and follow the study procedures
- Ability to complete the oculomotor exercise program, static posturography assessment, and gait analysis
- Provision of written informed consent
Exclusion Criteria:
- Acute musculoskeletal injury or pain that could affect balance, gait, or exercise performance
- Neurological disease that could affect balance, gait, or oculomotor control
- Vestibular disorder or current symptoms of dizziness or vertigo
- Visual or ocular disorder that could affect visual fixation, eye movements, or balance assessment
- Use of medication that could affect balance, coordination, alertness, or gait
- Inability to walk independently
- Inability to complete the oculomotor exercise intervention or assessment procedures
- Any medical condition considered by the investigator to interfere with safe participation or the validity of the assessments
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Oculomotor Exercise Group
Participants in this single-arm group will receive a single-session oculomotor exercise program.
Static posturography and gait analysis assessments will be performed before and after the intervention within the same testing session.
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The intervention consists of a single-session oculomotor exercise program including extraocular eye movement exercises, vestibulo-ocular and cervico-ocular gaze stabilization exercises, and accommodation exercises.
During extraocular eye movement exercises, participants will follow a visual target with eye movements while keeping the head stable.
During gaze stabilization exercises, participants will maintain visual fixation on a target while performing controlled head movements and walking steps.
During accommodation exercises, participants will alternate visual focus between a near target and a distant target.
Exercises will be performed at different speeds within the same session.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Sway Area Under Four Sensory Conditions
Periodo de tiempo: Baseline and 15 minutes after the intervention
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Sway area was assessed during 30 seconds of quiet standing using the HUR SmartBalance BTG4 static posturography system.
Measurements were obtained under four sensory conditions: eyes open on a firm surface, eyes closed on a firm surface, eyes open on a foam surface, and eyes closed on a foam surface.
Condition-specific sway area values were expressed using the same unit of measure (mm²).
The change from baseline to 15 minutes after the single-session oculomotor exercise intervention was evaluated separately for each sensory condition..
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Baseline and 15 minutes after the intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Trace Length Under Four Sensory Conditions
Periodo de tiempo: Baseline and 15 minutes after the intervention
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Trace length was assessed during 30 seconds of quiet standing using the HUR SmartBalance BTG4 static posturography system.
Measurements were obtained under eyes-open firm-surface, eyes-closed firm-surface, eyes-open foam-surface, and eyes-closed foam-surface conditions.
Condition-specific trace length values were expressed using the same unit of measure (mm).
The change from baseline to 15 minutes after the intervention was evaluated separately for each sensory condition.
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Baseline and 15 minutes after the intervention
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Change From Baseline in Single-Support Phase Percentage
Periodo de tiempo: Baseline and 15 minutes after the intervention
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Right and left single-support phase values were assessed during barefoot treadmill walking at 3 km/h using the DIERS Pedogait system.
Single support was expressed as a percentage of the gait cycle.
The change from baseline to 15 minutes after the intervention was evaluated separately for each side.
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Baseline and 15 minutes after the intervention
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Change From Baseline in Sway Velocity Under Four Sensory Conditions
Periodo de tiempo: Baseline and 15 minutes after the intervention
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Sway velocity was assessed during 30 seconds of quiet standing using the HUR SmartBalance BTG4 static posturography system.
Measurements were obtained under eyes-open firm-surface, eyes-closed firm-surface, eyes-open foam-surface, and eyes-closed foam-surface conditions.
Condition-specific sway velocity values were expressed using the same unit of measure (mm/s) .
The change from baseline to 15 minutes after the intervention was evaluated separately for each sensory condition.
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Baseline and 15 minutes after the intervention
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Change From Baseline in Mediolateral Sway Under Four Sensory Conditions
Periodo de tiempo: Baseline and 15 minutes after the intervention
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Mediolateral sway was assessed during 30 seconds of quiet standing using the HUR SmartBalance BTG4 static posturography system.
Measurements were obtained under eyes-open firm-surface, eyes-closed firm-surface, eyes-open foam-surface, and eyes-closed foam-surface conditions.
Condition-specific mediolateral sway values were expressed using the same unit of measure (mm).
The change from baseline to 15 minutes after the intervention was evaluated separately for each sensory condition.
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Baseline and 15 minutes after the intervention
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Change From Baseline in Anteroposterior Sway Under Four Sensory Conditions
Periodo de tiempo: Baseline and 15 minutes after the intervention
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Anteroposterior sway was assessed during 30 seconds of quiet standing using the HUR SmartBalance BTG4 static posturography system.
Measurements were obtained under eyes-open firm-surface, eyes-closed firm-surface, eyes-open foam-surface, and eyes-closed foam-surface conditions.
Condition-specific anteroposterior sway values were expressed using the same unit of measure (mm).
The change from baseline to 15 minutes after the intervention was evaluated separately for each sensory condition.
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Baseline and 15 minutes after the intervention
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Change From Baseline in Romberg Quotient on Firm and Foam Surfaces
Periodo de tiempo: Baseline and 15 minutes after the intervention
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The Romberg quotient was calculated using static posturography measurements obtained during eyes-open and eyes-closed standing.
Separate Romberg quotient values were calculated for the firm and foam surfaces using the HUR SmartBalance BTG4 system.
Both values were expressed using the same unit of measure.
The change from baseline to 15 minutes after the intervention was evaluated separately for each surface.
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Baseline and 15 minutes after the intervention
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Change From Baseline in Step Length
Periodo de tiempo: Time Frame: Baseline and 15 minutes after the intervention
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Right and left step length values were assessed during barefoot treadmill walking at 3 km/h using the DIERS Pedogait system.
Right and left values represented the same outcome variable and were expressed using the same unit of measure.
The change from baseline to 15 minutes after the intervention was evaluated separately for each side.
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Time Frame: Baseline and 15 minutes after the intervention
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Change From Baseline in Track Width
Periodo de tiempo: Baseline and 15 minutes after the intervention
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Track width was assessed during barefoot treadmill walking at 3 km/h using the DIERS Pedogait system.
Track width represents the mediolateral distance between consecutive foot placements.
The change from baseline to 15 minutes after the intervention was evaluated.
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Baseline and 15 minutes after the intervention
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Change From Baseline in Stride Length
Periodo de tiempo: Baseline and 15 minutes after the intervention
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Right and left stride length values were assessed during barefoot treadmill walking at 3 km/h using the DIERS Pedogait system.
Right and left values represented the same outcome variable and were expressed using the same unit of measure.
The change from baseline to 15 minutes after the intervention was evaluated separately for each side.
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Baseline and 15 minutes after the intervention
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Change From Baseline in Step Time
Periodo de tiempo: Baseline and 15 minutes after the intervention
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Right and left step time values were assessed during barefoot treadmill walking at 3 km/h using the DIERS Pedogait system.
Right and left values represented the same outcome variable and were expressed using the same unit of measure.
The change from baseline to 15 minutes after the intervention was evaluated separately for each side.
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Baseline and 15 minutes after the intervention
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Change From Baseline in Stride Time
Periodo de tiempo: Baseline and 15 minutes after the intervention
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Right and left stride time values were assessed during barefoot treadmill walking at 3 km/h using the DIERS Pedogait system.
Right and left values represented the same outcome variable and were expressed using the same unit of measure.
The change from baseline to 15 minutes after the intervention was evaluated separately for each side.
|
Baseline and 15 minutes after the intervention
|
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Change From Baseline in Stance Phase Percentage
Periodo de tiempo: Baseline and 15 minutes after the intervention
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Right and left stance phase values were assessed during barefoot treadmill walking at 3 km/h using the DIERS Pedogait system.
Stance phase was expressed as a percentage of the gait cycle.
The change from baseline to 15 minutes after the intervention was evaluated separately for each side.
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Baseline and 15 minutes after the intervention
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Change From Baseline in Pre-Swing Phase Percentage
Periodo de tiempo: Baseline and 15 minutes after the intervention
|
Right and left pre-swing phase percentages were assessed during barefoot treadmill walking at 3 km/h using the DIERS Pedogait system.
Pre-swing was expressed as a percentage of the gait cycle.
The change from baseline to 15 minutes after the intervention was evaluated separately for each side.
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Baseline and 15 minutes after the intervention
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Change From Baseline in Double-Support Phase Percentage
Periodo de tiempo: Baseline and 15 minutes after the intervention
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Right and left double-support phase percentages were assessed during barefoot treadmill walking at 3 km/h using the DIERS Pedogait system.
Double support was expressed as a percentage of the gait cycle.
The change from baseline to 15 minutes after the intervention was evaluated separately for each side.
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Baseline and 15 minutes after the intervention
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Change From Baseline in Swing Phase Percentage
Periodo de tiempo: Baseline and 15 minutes after the intervention
|
Right and left swing phase values were assessed during barefoot treadmill walking at 3 km/h using the DIERS Pedogait system.
Swing phase was expressed as a percentage of the gait cycle.
The change from baseline to 15 minutes after the intervention was evaluated separately for each side.
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Baseline and 15 minutes after the intervention
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Change From Baseline in Load Response Phase Percentage
Periodo de tiempo: Baseline and 15 minutes after the intervention
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Right and left load response phase values were assessed during barefoot treadmill walking at 3 km/h using the DIERS Pedogait system.
Load response was expressed as a percentage of the gait cycle.
The change from baseline to 15 minutes after the intervention was evaluated separately for each side.
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Baseline and 15 minutes after the intervention
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Change From Baseline in Single-Support Phase Percentage
Periodo de tiempo: Baseline and 15 minutes after the intervention
|
Right and left single-support phase percentages were assessed during barefoot treadmill walking at 3 km/h using the DIERS Pedogait system.
Single support was expressed as a percentage of the gait cycle.
The change from baseline to 15 minutes after the intervention was evaluated separately for each side.
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Baseline and 15 minutes after the intervention
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EUTF-OKULO-33058
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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