Mixed Reality With Hololens® Exercise Protocol
15 de marzo de 2019 actualizado por: Hector Beltran-Alacreu, Centro Universitario La Salle
Effectiveness of Mixed Reality With the Hololens System Versus Conventional Cervical Exercise Program for Asymptomatic Subjects. Crossover Pilot Study
The study design is a cross-over pilot study with 15 asymptomatic subjects.
There will be 2 groups, mixed reality group and conventional cervical exercise program.
Both groups received 2 sessions per week with an interval of 48 hours between them during 3 consecutive weeks.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study design is a cross-over pilot study. The study was approved by the ethical committee of the Centro Superior de Estudios Universitarios La Salle. People were recruited by referral from different places of the local community of Madrid according to the CONSORT statement (Consolidated Standards of Reporting Trials). Three assessors were trained during 300 minutes about how to perform the measurements (Investigator A) and the concerned intervention to each group (Investigator B and C). The whole procedure was conducted in the Centro Superior de Estudios Universitarios La Salle. After meeting the eligibility criteria for the study, participants were randomly allocated by an external investigator to one of the two groups:
- Mixed reality group
- Conventional Exercise group
Tipo de estudio
Intervencionista
Inscripción (Actual)
15
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Madrid, España, 28023
- CSEU La Salle
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 40 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age 18 to 40,
- Not experienced any neck and upper limb symptom
- Have no significant history of chronic pain disorder,
- Did not use any medication,
- Understand, write and speak Spanish fluently.
Exclusion Criteria:
- Craniocervical pain, peripheral neuropathy or history of migraine.
- Endocrine disorders, epilepsy or any psychiatric disorder, neurological disorder.
- Surgery and a history of traumatic injuries of the upper limb
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Mixed reality
Mixed reality exercise program using the Microsoft Hololens "Roboraid" game.
This group received 6 exercise sessions over 3 weeks, 2 days/week with an interval of 48 to 72 hours between sessions, using the Microsoft Hololens "Roboraid" game.
The duration of the sessions will be 10 minutes.
|
This group received 6 exercise sessions over 3 weeks, 2 days/week with an interval of 48 to 72 hours between sessions, using the Microsoft Hololens "Roboraid" game.
The duration of the sessions will be 10 minutes.
|
|
Comparador activo: Conventional exercise group
Conventional exercise program in cervical region based in deep neck flexors and deep neck extensors, isometric contraction during 6-8 seconds.
This group received 6 exercise sessions over 3 weeks, 2 days/week with an interval of 48 to 72 hours between sessions.
|
This group received 6 exercise sessions over 3 weeks, 2 days/week with an interval of 48 to 72 hours between sessions.
This program will consist on stabilisation exercises of the cervical region, in neck deep flexors and neck deep extensors muscles to provide them with strength and resistance
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Resistance test of the neck flexor muscles
Periodo de tiempo: change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
|
To perform this test that will give us the resistance in seconds, the therapist lifts the patient's head and neck until the occipital bone is approximately 2.5 cm from the table, keeping the chin tucked into the chest.
|
change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cervical Joint Position Error Test
Periodo de tiempo: change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
|
The aim of this test is to assess the subject's ability to return to the starting position after a cervical rotation movement has been performed.
The patient will remain seated in a chair with a backrest.
You will be given a headband with a laser pointer.
At 90 cm, a stitch (a kind of target) will be placed.
With the eyes closed, the participant will be asked to perform a cervical rotation and return to the starting position, as precisely as possible and without any feedback.
|
change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
|
|
Evaluation of User Satisfaction with Auxiliary Device Technology (QUEST 2.0)
Periodo de tiempo: change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
|
This consists of 12 questions, each one of which the participant should circle with a circle the number that best describes his or her degree of satisfaction from 1 to 5 (1 being unsatisfied and 5 very satisfied)
|
change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
|
|
System Usability Scale (SUS):
Periodo de tiempo: change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
|
It consists of 10 questions and the participant should dial the number that best describes their degree of satisfaction from 1 to 5 (1 being unsatisfied and 5 very satisfied)
|
change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
|
|
Suitability Evaluation Questionnaire (SEQ):
Periodo de tiempo: change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
|
Made up of 14 questions, one of which is an open-ended question.
For the remaining questions, the participant must select the number that best fits his or her answer, from 1 to 5, range 13 to 65 points.
Higher values represent more dificulty using the device.
This questionnaire assesses the subject's satisfaction and also the difficulty of its use.
|
change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
|
|
Q-Sense (Thermotest)
Periodo de tiempo: change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
|
Q-Sense is a validated device for the measurement of heat/cold thresholds and painful heat thresholds.
|
change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Edwards RR, Smith MT, Stonerock G, Haythornthwaite JA. Pain-related catastrophizing in healthy women is associated with greater temporal summation of and reduced habituation to thermal pain. Clin J Pain. 2006 Oct;22(8):730-7. doi: 10.1097/01.ajp.0000210914.72794.bc.
- Hoffman HG, Seibel EJ, Richards TL, Furness TA, Patterson DR, Sharar SR. Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. J Pain. 2006 Nov;7(11):843-50. doi: 10.1016/j.jpain.2006.04.006.
- Harris KD, Heer DM, Roy TC, Santos DM, Whitman JM, Wainner RS. Reliability of a measurement of neck flexor muscle endurance. Phys Ther. 2005 Dec;85(12):1349-55.
- Beltran-Alacreu H, Lopez-de-Uralde-Villanueva I, Fernandez-Carnero J, La Touche R. Manual Therapy, Therapeutic Patient Education, and Therapeutic Exercise, an Effective Multimodal Treatment of Nonspecific Chronic Neck Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2015 Oct;94(10 Suppl 1):887-97. doi: 10.1097/PHM.0000000000000293.
- Juul T, Langberg H, Enoch F, Sogaard K. The intra- and inter-rater reliability of five clinical muscle performance tests in patients with and without neck pain. BMC Musculoskelet Disord. 2013 Dec 3;14:339. doi: 10.1186/1471-2474-14-339.
- Shahrbanian S, Ma X, Korner-Bitensky N, Simmonds MJ. Scientific evidence for the effectiveness of virtual reality for pain reduction in adults with acute or chronic pain. Stud Health Technol Inform. 2009;144:40-3.
- Penasco-Martin B, de los Reyes-Guzman A, Gil-Agudo A, Bernal-Sahun A, Perez-Aguilar B, de la Pena-Gonzalez AI. [Application of virtual reality in the motor aspects of neurorehabilitation]. Rev Neurol. 2010 Oct 16;51(8):481-8. Spanish.
- Demers L, Monette M, Lapierre Y, Arnold DL, Wolfson C. Reliability, validity, and applicability of the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) for adults with multiple sclerosis. Disabil Rehabil. 2002 Jan 10-Feb 15;24(1-3):21-30. doi: 10.1080/09638280110066352.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
22 de octubre de 2018
Finalización primaria (Actual)
15 de marzo de 2019
Finalización del estudio (Actual)
15 de marzo de 2019
Fechas de registro del estudio
Enviado por primera vez
18 de septiembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
10 de octubre de 2018
Publicado por primera vez (Actual)
12 de octubre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de marzo de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
15 de marzo de 2019
Última verificación
1 de marzo de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Holo-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Mixed reality
-
Wen-zhao ZHONGGuangdong Provincial People's HospitalDesconocidoCáncer de pulmón | Nódulo Pulmonar Solitario | Nódulo Pulmonar Múltiple | Cirugía torácica asistida por videoPorcelana
-
Children's Hospital ColoradoChildren's Hospital Los AngelesReclutamientoEstudios de viabilidad | Aislamiento | Atención pediátrica para pacientes hospitalizadosEstados Unidos
-
Uludag UniversityTerminadoRealidad virtual | Educación sobre Lactancia Materna | Museo | Autoeficacia en la lactancia materna | MetaverPavo
-
McMaster UniversityGood Shepherd Health CentreTerminado