- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Bornova
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Izmir, Bornova, Турция (Туркие), 35100
- Ege University Faculty of Medicine, Department of Sports Medicine
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change From Baseline in Sway Area Under Four Sensory Conditions
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change From Baseline in Trace Length Under Four Sensory Conditions
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
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Baseline and 15 minutes after the intervention
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Change From Baseline in Stance Phase Percentage
Временное ограничение: 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
Временное ограничение: Baseline and 15 minutes after the intervention
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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
Временное ограничение: 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
Временное ограничение: Baseline and 15 minutes after the intervention
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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
Временное ограничение: 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
Временное ограничение: Baseline and 15 minutes after the intervention
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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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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- EUTF-OKULO-33058
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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