- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07619469
Motion Sickness Severity and Sensorimotor Performance
23. juni 2026 oppdatert av: Yunus Emre Tutuneken, Istinye University
The Relationship of Balance, Proprioception, Coordination, and Reaction Time Measurements With Motion Sickness Severity in Individuals With Motion Sickness: A Cross-Sectional Study
Background: Motion sickness (MS) is a common syndrome characterized by autonomic and behavioral symptoms, such as nausea and dizziness, resulting from exposure to motion stimuli.
Its pathophysiology is closely linked to sensory conflict and postural instability theories.
While previous studies suggest that postural control, proprioception, and reaction times are affected in individuals susceptible to MS, there is a lack of comprehensive, comparative research evaluating all these parameters concurrently within the same cohort using standardized methods.
Objective: This study aims to systematically measure balance, proprioceptive sensitivity, coordination, and reaction time parameters, and quantitatively analyze their relationship with motion sickness severity.
Methodology: In this prospective, cross-sectional study, at least 41 participants aged 18-40 with motion sickness will be recruited.
Participants will undergo motion sickness susceptibility and severity grading using the Motion Sickness Susceptibility Questionnaire Short Form (MSSQ-SF) and the Graybiel Scale.
Objective assessments will include static and dynamic balance testing (ProKin®), knee joint position sense (Clinometer app), manual dexterity and dynamic balance coordination (Nine-Hole Peg Test, Tandem Walk, Romberg Test), and upper/lower extremity reaction time measurements (BlazePod system).
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
41
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The study population consists of adult individuals aged between 18 and 40 years who exhibit susceptibility to motion sickness.
Beskrivelse
Inclusion Criteria:
- Individuals aged between 18 and 40 years.
- Diagnosed with motion sickness according to the Motion Sickness -Susceptibility Questionnaire Short Form (MSSQ-SF).
- Normal hearing acuity.
- No history of acute or chronic vestibular disease, other than motion sickness.
- Normal or corrected-to-normal vision.
- Adequate physical capability to fully perform the measurement protocols, including balance, proprioception, coordination, and reaction time tests.
Exclusion Criteria:
- Presence of any physical or orthopedic problem that could interfere with testing.
- History of acute or chronic instability, unsteadiness, or vertigo.
- Severe visual impairment.
- History of prior ear surgery.
- Presence of any neurological condition or disorder.
- History of migraines.
- Current use of medications that could affect balance or vestibular function (e.g., vestibular suppressants, sedatives).
- Use of alcohol or psychoactive substances within the last 48 hours prior to testing.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Static Balance
Tidsramme: 1 hour
|
Evaluated objectively using the ProKin® computerized balance system.
Participants stand on the platform under conditions: double-leg with eyes open.
|
1 hour
|
|
Dynamic Balance Performance
Tidsramme: 1 hour
|
Evaluated using the ProKin® system.
|
1 hour
|
|
Motion Sickness Severity (Graybiel Score)
Tidsramme: 1 hour
|
Used to grade the clinical severity of acute motion sickness symptoms (including nausea, cold sweating, increased salivation, and dizziness) following a randomized chair-rotation provocation protocol.
0 (Minimum) to 50 points (Maximum).
Higher scores indicate greater symptom severity, representing a worse clinical outcome (scores of 16 or above designate frank sickness).
|
1 hour
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Knee Joint Proprioception
Tidsramme: 1 hour
|
Evaluated in supine and prone positions, targeting knee angles of 15°, 30°, 60°, and 90° using the Clinometer digital inclinometer smartphone application.
|
1 hour
|
|
Nine-Hole Peg Test (9HPT) Completion Time
Tidsramme: 1 hour
|
Used to assess upper extremity dexterity and fine motor coordination.
Participants place nine pegs into the holes one by one and then remove them as quickly as possible.
|
1 hour
|
|
Tandem Walk Test Error Count
Tidsramme: 1 hour
|
Participants walk barefoot along a straight line for 10 steps, placing the heel of one foot directly against the toe of the other foot with arms relaxed at their sides.
|
1 hour
|
|
Visual Reaction Time
Tidsramme: 1 hour
|
Evaluated using the mobile application-based BlazePod.
|
1 hour
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
2. august 2026
Studiet fullført (Antatt)
5. august 2026
Datoer for studieregistrering
Først innsendt
26. mai 2026
Først innsendt som oppfylte QC-kriteriene
26. mai 2026
Først lagt ut (Faktiske)
2. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 25
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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