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临床试验/NCT02979041
NCT02979041已完成不适用

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

University of Haifa3 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
3
主要终点
Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

control

Active Comparator

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.

干预措施: Standard Care (Other)

intervention

Experimental

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.

干预措施: Interactive virtual reality training (Behavioral)

结局指标

主要结局

Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm)

时间窗: 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.

时间窗: 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.

时间窗: change from baseline at 4 weeks, 3 and 6 months.

The number of days the pilot was grounded due to neck pain.

次要结局

  • Cervical motion velocity is measured using the neck VR system (degrees/second)(change from baseline at 4 weeks, 3 and 6 months.)
  • Cervical range of motion is measured using the neck VR system (ROM, degrees)(change from baseline at 4 weeks, 3 and 6 months.)
  • Cervical muscles isometric strength is measures using a dynamometer (Newton)(change from baseline at 4 weeks, 3 and 6 months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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