- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Bornova
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Izmir, Bornova, Tyrkia (Türkiye), 35100
- Ege University Faculty of Medicine, Department of Sports Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in Sway Area Under Four Sensory Conditions
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in Trace Length Under Four Sensory Conditions
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EUTF-OKULO-33058
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