VR Training for Pilots With Neck Pain
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|ClinicalTrials.gov Identifier: NCT02979041|
Recruitment Status : Completed
First Posted : December 1, 2016
Last Update Posted : May 24, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Neck Pain Cervical Pain||Behavioral: Interactive virtual reality training Other: Standard Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Therapeutic Virtual Reality Training for Neck Pain in Israeli Air Force Pilots - A Randomized Controlled Trial|
|Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||December 30, 2017|
|Actual Study Completion Date :||December 30, 2017|
Active Comparator: 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.
Other: Standard Care
physiotherapy and medical care as provided currently
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.
Behavioral: Interactive virtual reality training
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.
- Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm) [ Time Frame: change from baseline at 4 weeks, 3 and 6 months. ]Pain intensity was measured using the Visual Analogue Scale (VAS, 0-100mm)
- Global perceived effect of the provided treatment is measured on a scale from -5 to +5. [ Time Frame: 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.
- Functional outcome is measured by the number of grounding days from flying due to neck pain. [ Time Frame: change from baseline at 4 weeks, 3 and 6 months. ]The number of days the pilot was grounded due to neck pain.
- Cervical range of motion is measured using the neck VR system (ROM, degrees) [ Time Frame: 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.
- Cervical motion velocity is measured using the neck VR system (degrees/second) [ Time Frame: 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.
- Cervical muscles isometric strength is measures using a dynamometer (Newton) [ Time Frame: 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- fighter and helicopter pilots from the Israeli Air Force
- acute, sub-acute, and chronic neck pain, with or without referral to the upper limbs
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979041
|The Faculty of Social Welfare and Health Sciences|
|Haifa, Israel, 3498838|
|Medical Aviation Unit|
|Tel Hashomer, Israel|
|Principal Investigator:||Hilla Sarig-Bahat, PT, PhD||Department of Physical Therapy, University of Haifa|
|Responsible Party:||University of Haifa|
|Other Study ID Numbers:||
|First Posted:||December 1, 2016 Key Record Dates|
|Last Update Posted:||May 24, 2018|
|Last Verified:||June 2016|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Range of motion