- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02733055
Posturography as Biomarker of Oculomotor and Postural Control Integration
Studieoversikt
Detaljert beskrivelse
Subjects will undergo computerized dynamic posturography (CDP) testing using the extended modified Clinical Testing of Sensory Integration in Balance (ext_mCTSIB) protocol: the subjects will be required to stand on a hard or the compliant surface in a comfortable posture, feet shoulder width, with eyes open or closed, arms to the side and free to move, gazing forward, and breathing normally, with head straight, turned right or left, flexed or extended. This testing will be used to determine the health status of the subjects.
Then a sequence of tests will be performed (they could be done in different days to avoid fatiguing the subject): each sequence will comprise of a baseline test in one of the ext_mCTSIB testing conditions and a subsequent test in the same conditions but with an oculomotor additional task, such as gazing in a specific direction other than straight, performing saccades in different directions, at different speed and using different paradigms (prosaccades, antisaccades, to a remembered target, gap saccades, …), following a target moving on the screen at different speed and in different directions, receiving an optokinetic stimulation in different directions and at different speeds. Video recordings of the eyes movement may be done to make sure that the subject is actually moving the eyes, to verify that the observers are well trained to detect and count the saccadic movements, as well as to obtain quantitative information regarding the eye movements per se.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Victoria
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Hampton, Victoria, Australia, 3188
- Carrick Institute for Graduate Studies
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Georgia
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Atlanta, Georgia, Forente stater, 30339
- Carrick Institute for Graduate Studies
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Self assessed healthy subjects
Exclusion Criteria:
- subjects suffering from pathology known to affect balance
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: subjects
participant undergoing posturographic evaluation
|
subjects will undergo CDP testing using one of the ext_mCTSIB tests without (baseline) and with oculomotor task
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Stability Score
Tidsramme: immediately after data collection
|
The Stability Score (calculated as percentage ratio of the actual sway and the theoretical limit of stability) will be used to investigate if there is any difference between the test without and with oculomotor task.
Statistical tools such t-tests and correlation coefficients will be used to assess if there is a difference between the two tests
|
immediately after data collection
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
average velocity moment [mm^2/s]
Tidsramme: immediately after data collection
|
The average velocity moment (calculated as as the product of sway velocity path length) will be used to investigate if there is any difference between the test without and with oculomotor task.
Statistical tools such t-tests and correlation coefficients will be used to assess if there is a difference between the two tests
|
immediately after data collection
|
|
sway path length [mm]
Tidsramme: immediately after data collection
|
The sway path length (the distance traveled during the test) will be used to investigate if there is any difference between the test without and with oculomotor task.
Statistical tools such t-tests and correlation coefficients will be used to assess if there is a difference between the two tests
|
immediately after data collection
|
|
frequency content [Hz]
Tidsramme: immediately after data collection
|
The frequency content (calculated using FFT) will be used to investigate if there is any difference between the test without and with oculomotor task.
Statistical tools such t-tests and correlation coefficients will be used to assess if there is a difference between the two tests
|
immediately after data collection
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Paul Noone, PhD, Carrick Institute for Graduate Studies
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
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
Andre studie-ID-numre
- CI-IRB-20160321002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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