- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01911338
Inertial Sensors Used to Learn Manipulation
3. prosince 2014 aktualizováno: Dr. Antonio I Cuesta-Vargas, University of Malaga
EFFECT OF REAL-TIME FEEDBACK THROUGH INERTIAL SENSORS IN LEARNING POSTEROANTERIOR THORACIC MANIPULATION
- Background Context: no studies have been identified to analyse the effect of real time feedback (using inertial sensors) on physiotherapy students learning the art of posterior-anterior thoracic manipulation (PATM).
- Purpose: to study the effect caused by real-time feedback on the learning process for PATM, comparing two undergraduate physiotherapy student groups. Hypothesis: significant differences will exist in the execution parameters of manipulation among students receiving real-time feedback versus those who do not.
- Study Design/Setting: longitudinal, pre-post intervention.
- Patient Sample: Sixty-one undergraduate physiotherapy students were divided randomly into two groups, G1 (n = 31) (group without feedback in real time) and G2 (n = 30) (group with real-time feedback).
- Outcome Measures: time, displacement and velocity and improvement (only between groups) to reach maximum peak, to reach minimum peak from maximum peak, total manipulation time.
- Methods: two groups of physiotherapy students learned PATM, one using a traditional method and the other using real-time feedback (inertial sensor). Measures were obtained pre- and post-intervention. Intragroup pre- and post-intervention and intergroup post-intervention scores were calculated. An analysis of the measures' stability was developed through an ICC (1,2).
- Results: the values of ICC ranged from 0.881 to 0.997. Statistically significant differences were found in all variables analysed (intra- and inter-group) in favour of G2.
- Conclusions: the learning process for posterior-anterior thoracic manipulation is facilitated when the student receives real-time feedback.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
64
Fáze
- Nelze použít
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 65 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Participants did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Exclusion Criteria:
- Refusal to participate in the study
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Real Time Feedback
Before beginning practice, one of the teachers performed the manipulation and explained the graph parameters as real-time feedback to consider when interpreting the graph, leaving the graphic as the benchmark execution
|
Before beginning practice, one of the teachers performed the manipulation and explained the graph parameters as real-time feedback to consider when interpreting the graph, leaving the graphic as the benchmark execution
|
|
Aktivní komparátor: Tradicional Learning Method
Two expert teachers in manual therapy provided indications and corrections to the group with a teacher - student ratio of 1:8
|
Two expert teachers in manual therapy provided indications and corrections to the group with a teacher - student ratio of 1:8.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from displacement maximum peak (seconds)
Časové okno: baseline; post-education; 24 weeks follow up
|
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM.
The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor.
The manikin has a ribcage with a deformation capacity similar to that of a human thorax.
This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students.
The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
|
baseline; post-education; 24 weeks follow up
|
|
Change from Time to reach maximum peak (seconds)
Časové okno: baseline; post-education; 24 weeks follow up
|
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM.
The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor.
The manikin has a ribcage with a deformation capacity similar to that of a human thorax.
This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students.
The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
|
baseline; post-education; 24 weeks follow up
|
|
Change from Displacement between maximum and minimum peak (milimitres)
Časové okno: baseline; post-education; 24 weeks follow up
|
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM.
The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor.
The manikin has a ribcage with a deformation capacity similar to that of a human thorax.
This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students.
The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
|
baseline; post-education; 24 weeks follow up
|
|
Change from Total manipulation time (seconds)
Časové okno: baseline; post-education; 24 weeks follow up
|
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM.
The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor.
The manikin has a ribcage with a deformation capacity similar to that of a human thorax.
This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students.
The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
|
baseline; post-education; 24 weeks follow up
|
|
Change from Velocity to reach maximum peak (degrees per second)
Časové okno: baseline; post-education; 24 weeks follow up
|
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM.
The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor.
The manikin has a ribcage with a deformation capacity similar to that of a human thorax.
This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students.
The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
|
baseline; post-education; 24 weeks follow up
|
|
Change from Time to reach peak minimum from maximum peak (seconds)
Časové okno: baseline; post-education; 24 weeks follow up
|
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM.
The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor.
The manikin has a ribcage with a deformation capacity similar to that of a human thorax.
This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students.
The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
|
baseline; post-education; 24 weeks follow up
|
|
Change from Velocity to reach minimum peak from maximum peak (degress/second)
Časové okno: baseline; post-education; 24 weeks follow up
|
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM.
The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor.
The manikin has a ribcage with a deformation capacity similar to that of a human thorax.
This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students.
The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
|
baseline; post-education; 24 weeks follow up
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Manuel González-Sánchez, PT, PhD, University of Malaga
- Vrchní vyšetřovatel: Yves Lenfant, PT, University of Malaga
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. února 2012
Primární dokončení (Aktuální)
1. června 2012
Dokončení studie (Aktuální)
1. září 2012
Termíny zápisu do studia
První předloženo
23. července 2013
První předloženo, které splnilo kritéria kontroly kvality
29. července 2013
První zveřejněno (Odhad)
30. července 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
4. prosince 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
3. prosince 2014
Naposledy ověřeno
1. července 2013
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- ACuesta07072013
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Lékařské vzdělání
-
Bahar DönerIstanbul University - CerrahpasaDokončenoNURSİNG EDUCATİON | ŘEŠENÍ PROBLÉMŮ | EMPATIE V OŠETŘOVATELSTVÍ | NEVİOLENTNİ KOMUNİKACE | KONSTRUKTIVISTICKÝ VÝUKOVÝ MODELTurecko (Türkiye)
-
Kutahya Health Sciences UniversityZatím nenabírámeBolest | Fyzická aktivita | Pediatrie | Neuroscience Pain EducationKrocan
-
Universitaire Ziekenhuizen KU LeuvenDokončenoTest-retest Spolehlivost | Platnost | Dynamometr Biodex Medical Systems III | Experimentální měření síly protažení kolenBelgie
-
Centre Hospitalier Universitaire de LiegeZatím nenabírámeDiabetes Mellitus Self Management EducationBelgie
-
University College DublinUniversity College Cork; InterregZatím nenabírámeBolest | Chronická bolest | Virtuální realita | Dospělí | Neuroscience Pain Education | Chronická bolest (záda / šíje)Irsko
-
Kutahya Health Sciences UniversityDokončenoChronická bolest dolní části zad | Manuální terapie | Neuroscience Pain EducationKrocan
-
US Department of Veterans AffairsDokončenoDiabetes Mellitus Self Management Education | Hyperglykemická kontrola | Vysoce rizikový diabetesSpojené státy
-
Necmettin Erbakan UniversityZatím nenabírámePéče o kůži | Diabetes Mellitus, typ II | Diabetes Mellitus Self Management Education
-
Changhai HospitalZatím nenabírámeOddělení anorektální chirurgie, nemocnice Changhai Přidružená k Naval Medical University
-
Virginia Commonwealth UniversityZápis na pozvánkuVlastní správa | Diabetes Mellitus Self Management Education | Hypertenze samosprávySpojené státy
Klinické studie na Real Time Feedback
-
Peking Union Medical College HospitalShandong Provincial Hospital; Henan Provincial People's Hospital; Chongqing General... a další spolupracovníciZatím nenabírámeZávažné onemocnění | Respirační selhání | ARDS (syndrom akutní respirační tísně) | VILI (Poškození plic vyvolané ventilátorem)
-
Zeta TechnologiesUniversity Hospital, ToulouseNeznámý
-
Second Affiliated Hospital of Wenzhou Medical UniversityNorthwestern UniversityNáborInkontinence moči, nutkáníČína
-
University of LouisvilleUkončenoPříznaky deprese
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldDokončeno
-
Keio UniversityDokončenoSomatosenzorické evokované potenciály a elektroencefalografieJaponsko
-
Tel-Aviv Sourasky Medical CenterTel Aviv UniversityNeznámý
-
Regionsenter for barn og unges psykiske helseThe Research Council of Norway; Regional kunnskapssenter for barn og unge -... a další spolupracovníciDokončeno
-
University of MinnesotaUkončeno
-
Istituto Ortopedico GaleazziNáborPooperační hematom, náhrada kyčle, chirurgieItálie