- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02577653
Posturographic Characteristics of Eccentric, Isometric and Concentric Movements
16 februari 2017 uppdaterad av: Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies
Determine the posturographic characteristics of eccentric, isometric and concentric movements in healthy subjects as well as in subjects with chronic, orthopedic conditions / pain not involving the lower extremities.
The squatting movement (going down from a stand up position, bending the ankle, knee and hip joints, and then returning to the stand up position, while not lifting the feet from the supporting ground surface) is a simple motion that involves all three types of movements: eccentric (the going down), isometric (holding the down position for a couple of seconds) and concentric (the coming up).
It is hypothesized that non-healthy subjects will not have "smooth" movements, and posturography could be used to separate between healthy and non-healthy subjects.
Studieöversikt
Status
Indragen
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Subjects will undergo Computerized Dynamic Posturography (CDP) testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface (a 4" tall foam cushion of known mechanical properties) in a comfortable posture, feet shoulder width, with eyes open or closed, head straight and arms to the side and free to move, gazing forward, and breathing normally.
Subsequently, subjects will be asked to stand first on the right leg and then on the left leg, raising the other leg (flexing the hip about 45 degrees), bending (flexing) the knee 90 degrees, keeping the arms extended and moving them laterally (abduct shoulders to 45 degrees and extend both elbows) to help maintaining balance with eyes open.
Finally, subjects will be asked to perform 10 repetition of the squatting movement, with the operator pacing them (telling them when to start and when to stop the movements).
The results of the mCTSIB, combined with an initial physical and neurological examination will be used to classify the subjects into the healthy and non healthy group.
Studietyp
Interventionell
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Georgia
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Savannah, Georgia, Förenta staterna, 31405
- Optim Orthopedics - DeRenne
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- subjects with chronic, orthopedic conditions / pain
Exclusion Criteria:
- involving the lower extremities
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
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 |
|---|---|
|
Övrig: subjects
participant undergoing posturographic evaluation
|
Subjects will undergo CDP testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol.
Subsequently, subjects will be asked to stand first on the right leg and then on the left leg with eyes open.
Finally, subjects will be asked to perform 10 repetition of the squatting movement, with the operator pacing them (telling them when to start and when to stop the movements).
|
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 healthy controls and subjects affected by chronic pain not involving the lower extremities.
Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups
|
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 healthy controls and subjects affected by chronic pain not involving the lower extremities.
Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups
|
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 healthy controls and subjects affected by chronic pain not involving the lower extremities.
Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups
|
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 healthy controls and subjects affected by chronic pain not involving the lower extremities.
Statistical tools such t-tests and correlation coefficients will be used for assess if there is a difference between the two groups
|
immediately after data collection
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2015
Primärt slutförande (Faktisk)
1 januari 2017
Avslutad studie (Faktisk)
1 januari 2017
Studieregistreringsdatum
Först inskickad
2 oktober 2015
Först inskickad som uppfyllde QC-kriterierna
14 oktober 2015
Första postat (Uppskatta)
16 oktober 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 februari 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 februari 2017
Senast verifierad
1 februari 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CI-IRB-20150818005
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .