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临床试验/NCT05664620
NCT05664620招募中不适用

Development of a Persisting Concussion Symptoms (PCS) Risk Stratification Tool and Evaluation of the Effectiveness of an Enhanced WSIB Multidisciplinary Individualized Treatment Program to Enhance Return to Work and Recovery

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年2月17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
75
试验地点
2
主要终点
Return to work

研究概览

简要总结

Patients with Persisting Concussion Symptoms (PCS) have a multitude of different symptoms. Some patients are at risk of prolonged symptoms but currently there is no tool to assist in identifying patients at high risk. Intensive, multidisciplinary intervention is time-consuming and expensive and may not be warranted for all PCS patients, so it is essential to identify early on which patients are at risk of prolonged symptoms. The aim of this study is to improve the quality of care delivered to patients, especially those who are at high-risk of prolonged PCS by early identification and treatment of all the symptoms. The purpose of this research is to validate the use of a Persisting Concussion Symptoms (PCS) Risk Stratification Tool (RST).

详细描述

The information from 500 hundred concussion patients were used to develop the PCS RST. This is a screening tool that will assist in predicting patient outcomes by allocating patients with PCS into a low, medium and high risk group for prolonged PCS symptoms. This categorization would help target those patients at high risk of prolonged symptoms with a multidisciplinary individualized treatment and evaluate the effectiveness of it on return to work and recovery. For this research study, we ask workers who have had concussions and are categorized as high high risk (with PCS RST) for prolonged PCS symptoms to undergo individualized treatments and we will examine their recovery and return to work.

The study will involve 75 patients with persisting concussion symptoms from the Canadian Concussion Centre clinics and Altum Health concussion clinic at Toronto Western Hospital.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18-60 years old
  • Clinical diagnosis of PCS for 1-12 months with at least 3 symptoms
  • Must be employed at time of injury
  • Full-time or part-time worker prior to concussion and cannot return to work
  • Must speak English and be sufficiently literate to complete questionnaires and perform assessments
  • Must be able to give consent

排除标准

  • Abnormalities on MRI such as contusion, hemorrhages, siderosis, or other non-traumatic conditions
  • History of neurological conditions (e.g. stroke, seizures) or major psychiatric disease

结局指标

主要结局

Return to work

时间窗: 12 months after treatment start day

The Primary Outcome is the percentage of concussed workers who ultimately RTW one year after the treatment commences. The Recovery and Return to Work tracker will be completed in 3,6,9 and 12 months to track their recovery. However, the primary endpoint is "Return to work at 12 months."

次要结局

  • Work Quality(12 months after treatment start day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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