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Completed

NCT Number: NCT03703518

Mixed Reality With Hololens® Exercise Protocol

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.

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Key information

Conditions

Healthy Volunteers Behavior Motor Activity

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CSEU La Salle

Madrid, 28023, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Centro Universitario La Salle

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 12, 2018
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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