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Mixed Reality With Hololens® Exercise Protocol

15. mars 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Faktiske)

15

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
      • Madrid, Spania, 28023
        • CSEU La Salle

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 40 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Aktiv komparator: 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.
Annen: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Resistance test of the neck flexor muscles
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cervical Joint Position Error Test
Tidsramme: 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)
Tidsramme: 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):
Tidsramme: 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):
Tidsramme: 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)
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centro Universitario La Salle

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. oktober 2018

Primær fullføring (Faktiske)

15. mars 2019

Studiet fullført (Faktiske)

15. mars 2019

Datoer for studieregistrering

Først innsendt

18. september 2018

Først innsendt som oppfylte QC-kriteriene

10. oktober 2018

Først lagt ut (Faktiske)

12. oktober 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. mars 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. mars 2019

Sist bekreftet

1. mars 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • Holo-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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