- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02733055
Posturography as Biomarker of Oculomotor and Postural Control Integration
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Victoria
-
Hampton, Victoria, Australien, 3188
- Carrick Institute for Graduate Studies
-
-
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30339
- Carrick Institute for Graduate Studies
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Self assessed healthy subjects
Exclusion Criteria:
- subjects suffering from pathology known to affect balance
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: subjects
participant undergoing posturographic evaluation
|
subjects will undergo CDP testing using one of the ext_mCTSIB tests without (baseline) and with oculomotor task
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Stability Score
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
average velocity moment [mm^2/s]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Paul Noone, PhD, Carrick Institute for Graduate Studies
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- CI-IRB-20160321002
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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