Clinical trial NCT03703518: Mixed Reality With Hololens® Exercise Protocol
Official title: Effectiveness of Mixed Reality With the Hololens System Versus Conventional Cervical Exercise Program for Asymptomatic Subjects. Crossover Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Mixed reality
Exercise
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: cross-over pilot study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Resistance test of the neck flexor muscles
timeFrame: change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
Secondary outcomes:
measure: Cervical Joint Position Error Test
timeFrame: change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
measure: Evaluation of User Satisfaction with Auxiliary Device Technology (QUEST 2.0)
timeFrame: change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
measure: System Usability Scale (SUS):
timeFrame: change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
measure: Suitability Evaluation Questionnaire (SEQ):
timeFrame: change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
measure: Q-Sense (Thermotest)
timeFrame: change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.