Mixed Reality With Hololens® Exercise Protocol

March 15, 2019 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28023
        • CSEU La Salle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.
Active Comparator: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resistance test of the neck flexor muscles
Time Frame: 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)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Universitario La Salle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2018

Primary Completion (Actual)

March 15, 2019

Study Completion (Actual)

March 15, 2019

Study Registration Dates

First Submitted

September 18, 2018

First Submitted That Met QC Criteria

October 10, 2018

First Posted (Actual)

October 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 15, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Holo-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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