Mixed Reality With Hololens® Exercise Protocol

Study Overview
=================
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

Official Title
-----------------
Effectiveness of Mixed Reality With the Hololens System Versus Conventional Cervical Exercise Program for Asymptomatic Subjects. Crossover Pilot Study

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Other: Mixed reality
* Other: Conventional exercise group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: cross-over pilot study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mixed reality<br>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<br>* 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.<br>|
| Active Comparator: Conventional exercise group<br>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<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical Joint Position Error Test | 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) | 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): | 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): | 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) | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mixed reality, Exercise