- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01911338
Inertial Sensors Used to Learn Manipulation
3 décembre 2014 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
64
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from displacement maximum peak (seconds)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Manuel González-Sánchez, PT, PhD, University of Malaga
- Chercheur principal: Yves Lenfant, PT, University of Malaga
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 février 2012
Achèvement primaire (Réel)
1 juin 2012
Achèvement de l'étude (Réel)
1 septembre 2012
Dates d'inscription aux études
Première soumission
23 juillet 2013
Première soumission répondant aux critères de contrôle qualité
29 juillet 2013
Première publication (Estimation)
30 juillet 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
4 décembre 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 décembre 2014
Dernière vérification
1 juillet 2013
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- ACuesta07072013
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .