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VR Training for Pilots With Neck Pain

23. maj 2018 opdateret af: University of Haifa

Therapeutic Virtual Reality Training for Neck Pain in Israeli Air Force Pilots - A Randomized Controlled Trial

The aim of the proposed study is to investigate the effectiveness of an interactive, virtual reality (VR) training program for pilots compared with standard care. The study will be a randomized controlled trial (RCT) consisting of 60 pilots randomized into one of two groups: standard physiotherapy and medical care vs standard care and VR training. Outcome measures will include subjective scores of pain intensity and global perceived effect; objective measures of range of motion (ROM), neck motion velocity, and motion accuracy; and functional measure of days grounded due to neck pain. Data will be analyzed using ANOVA for within and between groups analyses.

Studieoversigt

Detaljeret beskrivelse

The aim of the proposed study is to investigate the effectiveness of an interactive, virtual reality (VR) training program for pilots compared with standard care. The proposed intervention program includes training in neck range of motion, control, accuracy and coordination and is expected to reduce the prevalence and operational impact of neck pain in the intervention group more effectively than does standard care alone.

The proposed study will be designed as a randomized, controlled trial (RCT). Sixty fighter and helicopter pilots will be randomized into two groups, to receive either standard physiotherapy and medical care or standard care with the addition of interactive, dynamic, controlled training (a self-exercise program) in VR to address the fast, accurate head control required in flying tasks.

Subjective outcome measures will include pain intensity and global perceived effect. Objective measures will include range of motion, motion velocity and accuracy. The functional measure will include days grounded due to neck pain.

Statistical analysis will use independent, repeated measures ANOVA on each parameter, within and between groups. Post hoc comparisons, including several preplanned contrasts, will be performed to assess differences before and after treatment, and the stability of changes over time, in each group. The relationship of risk factors to performance failures will be assessed using multivariate logistic regression analyses.

This study is the first in the Israeli Air Force to evaluate this type of comprehensive, functional intervention program. Such research will dramatically advance the military's health care approach to neck pain, and may be further applied to other populations in and outside the Israeli Defence Force (IDF). This study may serve as a stepping stone to further research related to diagnosis, treatment, and prevention methods during a pilot's active service.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

47

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Haifa, Israel, 3498838
        • The Faculty of Social Welfare and Health Sciences
      • Tel Hashomer, Israel
        • Medical Aviation Unit

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • fighter and helicopter pilots from the Israeli Air Force
  • acute, sub-acute, and chronic neck pain, with or without referral to the upper limbs

Exclusion Criteria:

  • neurological disorders (e.g. evidence for positive neurological signs), systemic disease, history of spinal surgery, or any disorders that may limit the ability to exercise

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: control
Patients in the control group will receive standard physiotherapy and medical care, as provided to all patients with neck pain in the aviation medicine clinic. This will reflect the standard care that has been provided to all patients.
physiotherapy and medical care as provided currently
Eksperimentel: intervention
Standard care (as provided to controls) with the addition of virtual reality training (a self-exercise program) using a VR system to address the fast, accurate head control required in flying tasks.

The proposed VR intervention program will provide active training to be performed individually 4 times a week for 20 minutes a session.

The intervention program will be supervised by qualified, experienced physiotherapists, and will include individual training and two follow up meetings during the study period. The intervention program will include strengthening and endurance exercises for the cervical and shoulder girdle muscles. Training will include sensorimotor control and functional, quick, accurate, neck motion, using interactive VR training systems. This type of advanced training is very relevant to the pilots function in the cockpit as it includes interactive tasks aimed to increase range, speed, smoothness, accuracy, and control of cervical motion.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm)
Tidsramme: change from baseline at 4 weeks, 3 and 6 months.
Pain intensity was measured using the Visual Analogue Scale (VAS, 0-100mm)
change from baseline at 4 weeks, 3 and 6 months.
Global perceived effect of the provided treatment is measured on a scale from -5 to +5.
Tidsramme: change from baseline at 4 weeks, 3 and 6 months.
Global perceived effect of the provided treatment was measured on a scale from -5 to +5. Zero represented no change, +5 excellent improvement due to the treatment provided, and -5, vast worsening.
change from baseline at 4 weeks, 3 and 6 months.
Functional outcome is measured by the number of grounding days from flying due to neck pain.
Tidsramme: change from baseline at 4 weeks, 3 and 6 months.
The number of days the pilot was grounded due to neck pain.
change from baseline at 4 weeks, 3 and 6 months.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cervical range of motion is measured using the neck VR system (ROM, degrees)
Tidsramme: change from baseline at 4 weeks, 3 and 6 months.
Cervical range of motion (ROM, degrees) is measured using the neck VR system, into flexion, extension, right and left rotation.
change from baseline at 4 weeks, 3 and 6 months.
Cervical motion velocity is measured using the neck VR system (degrees/second)
Tidsramme: change from baseline at 4 weeks, 3 and 6 months.
Cervical motion velocity is measured using the neck VR system (degrees/second) into flexion, extension, right and left rotation.
change from baseline at 4 weeks, 3 and 6 months.
Cervical muscles isometric strength is measures using a dynamometer (Newton)
Tidsramme: change from baseline at 4 weeks, 3 and 6 months.
Cervical muscles isometric strength is measures using a dynamometer (Newton), in the directions of static flexion and extension.
change from baseline at 4 weeks, 3 and 6 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Hilla Sarig-Bahat, PT, PhD, Department of Physical Therapy, University of Haifa

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2016

Primær færdiggørelse (Faktiske)

30. december 2017

Studieafslutning (Faktiske)

30. december 2017

Datoer for studieregistrering

Først indsendt

5. oktober 2016

Først indsendt, der opfyldte QC-kriterier

28. november 2016

Først opslået (Skøn)

1. december 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. maj 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2018

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UHaifaAF

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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