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VR Training for Pilots With Neck Pain

23. Mai 2018 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

47

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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
Experimental: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm)
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cervical range of motion is measured using the neck VR system (ROM, degrees)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2016

Primärer Abschluss (Tatsächlich)

30. Dezember 2017

Studienabschluss (Tatsächlich)

30. Dezember 2017

Studienanmeldedaten

Zuerst eingereicht

5. Oktober 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. November 2016

Zuerst gepostet (Schätzen)

1. Dezember 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Mai 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Mai 2018

Zuletzt verifiziert

1. Juni 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • UHaifaAF

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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