Mixed Reality With Hololens® Exercise Protocol

NCT ID: NCT03703518

Last Updated: 2019-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-22

Study Completion Date

2019-03-15

Brief Summary

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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

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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

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

cross-over pilot study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mixed reality

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Conventional exercise group

Intervention Type OTHER

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

Interventions

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Mixed reality

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.

Intervention Type OTHER

Conventional exercise group

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centro Universitario La Salle

OTHER

Sponsor Role lead

Responsible Party

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Hector Beltran-Alacreu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CSEU La Salle

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 16988570 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19592727 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17074626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20925030 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25888653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16305273 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24299621 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11827151 (View on PubMed)

Other Identifiers

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Holo-01

Identifier Type: -

Identifier Source: org_study_id

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