Mixed Reality With Hololens® Exercise Protocol

NCT03703518 | Completed

• 1 other identifier: Holo-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Mixed reality; Exercise

Outcome Measures

Primary Outcomes (1)

• Resistance test of the neck flexor muscles

  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)

Secondary Outcomes (5)

• Cervical Joint Position Error Test

  change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)

• Evaluation of User Satisfaction with Auxiliary Device Technology (QUEST 2.0)

  change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)

• System Usability Scale (SUS):

  change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)

• Suitability Evaluation Questionnaire (SEQ):

  change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)

• Q-Sense (Thermotest)

  change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)

Study Arms (2)

Mixed reality

EXPERIMENTAL

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.

Other: Mixed reality

Conventional exercise group

ACTIVE COMPARATOR

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.

Other: Conventional exercise group

Interventions

Mixed reality 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.

Mixed reality

Conventional exercise group 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

Conventional exercise group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Universitario La Salle: lead

Study Sites (1)

CSEU La Salle

Madrid, 28023, Spain

Location

Related Publications (8)

• 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.

  PMID: 16988570 BACKGROUND

• 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.

  PMID: 19592727 BACKGROUND

• 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.

  PMID: 17074626 BACKGROUND

• 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.

  PMID: 20925030 BACKGROUND

• 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.

  PMID: 25888653 BACKGROUND

• 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.

  PMID: 16305273 BACKGROUND

• 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.

  PMID: 24299621 BACKGROUND

• 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.

  PMID: 11827151 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: cross-over pilot study

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: October 12, 2018
• Study Start: October 22, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)