跳至主要内容
临床试验/NCT05111925
NCT05111925招募中不适用

Pre-neuromusculoskeletal Injury Risk Factor Evaluation and Post-neuromusculoskeletal Injury Assessment for Return-to-duty/Activity Enhancement

Womack Army Medical Center4 个研究点 分布在 1 个国家目标入组 2,690 人开始时间: 2022年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,690
试验地点
4
主要终点
Number of musculoskeletal injuries (MSKIs) by study participant.

研究概览

简要总结

The purpose of this study is to develop comprehensive and efficient pre- and post- musculoskeletal injury (MSKI) risk assessments for Service members, incorporating both objective and subjective measures. This is a multi-site observational study to identify the pre- and post-MSKI physical and psychosocial factors contributing to MSKI risks and undesired patient outcomes following MSKI. The study hypothesis is that a set of field-expedient clinical assessments can identify Service member specific MSKI risk factors and post-MSKI deficits that contribute to undesired patient outcomes and provide data to guide patient-specific risk mitigation and rehabilitation programs.

详细描述

Non-combat related musculoskeletal injuries (MSKI) are the leading cause of morbidity and disability in the United States Military, eroding combat readiness more than any other single disease or health condition. The MSKI problem is challenging to address, in part because it is difficult to comprehensively assess all of the factors that increase MSKI risk and those factors that influence post-MSKI outcomes, value-based care must have the necessary infrastructure to capture and process actionable information, and then implement relevant changes (i.e., learning healthcare system). However, there are no comprehensive Military Health System (MHS) recommendations regarding the collection and use of objective and subjective patient-centric data to inform MSKI risk assessment and mitigation strategies. PREPARE will develop efficient pre- and post-MSKI risk assessments that incorporate objective and subjective measures. The overall study objective is to develop comprehensive clinical assessments that identify the Service member specific factors that contribute to MSKI risks and undesired post-MSKI outcomes.

These objectives will be achieved by the following Specific Aims (SA):

Specific Aim #1: Determine the intra-rater, inter-rater, and inter-day reliability of the study related measurements within a (pilot) cohort of healthy active duty Service members.

Hypothesis SA#1: There will be good-to-excellent intra-rater, inter-rater, and inter-day reliability for study related measurements.

Specific Aim #2: Determine the pre-MSKI physical and psychosocial traits of Service members that differentiate between individuals who go on to sustain an MSKI and those who do not within 1 year of study enrollment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Pilot Cohort
  • Active duty Service members cleared for full physical activity.
  • 18-44 years old
  • Uninjured Cohorts
  • Active duty Service members cleared for full physical activity.
  • 18-44 years old
  • Injured Cohorts
  • Active duty Service members receiving conservative treatment exclusively for a musculoskeletal injury affecting the low back or lower extremity.
  • Recruited at any time following presentation to a rehabilitation care facility for care of the MSKI of interest
  • 18-44 years old

排除标准

  • Pilot Cohort
  • Currently on limited duty status, for any reason.
  • Unable to read or comprehend the English language.
  • Pregnant females (will be eligible for participation in the study after the pregnancy)
  • Uninjured Cohorts
  • Currently on limited duty status, for any reason.
  • Scheduled for a deployment or separation from current unit within the next 12 months.
  • Unable to read or comprehend the English language.
  • Pregnant females (will be eligible for participation in the study after the pregnancy)
  • Injured Cohorts
  • Unable to read or comprehend the English language.
  • A MSKI within the last 6 months.
  • History of lower extremity or low back musculoskeletal related surgery.
  • History of moderate or severe traumatic brain injury.
  • Pregnant females (will be eligible for participation in the study after the pregnancy)

结局指标

主要结局

Number of musculoskeletal injuries (MSKIs) by study participant.

时间窗: through study completion, an average of 1 year.

Each MSKI that requires a participant to either seek medical attention from a healthcare provider or to not participate in normal physical activity for 1 or more consecutive days will be recorded.

次要结局

  • Percentage of participants who go on to develop a self-reported MSKI.(1 year.)
  • Time to Complete the PREPARE Clinical Assessment(1 year.)
  • Time to MSKI(through study completion, an average of 1 year.)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Megan Roach

Lead Musculoskeletal Health Scientist

Womack Army Medical Center

研究点 (4)

Loading locations...

相似试验