Viewing Study NCT05664620


Ignite Creation Date: 2025-12-25 @ 4:25 AM
Ignite Modification Date: 2025-12-26 @ 3:28 AM
Study NCT ID: NCT05664620
Status: UNKNOWN
Last Update Posted: 2022-12-27
First Post: 2022-11-22
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Post Concussion Symptoms Risk Stratification Tool
Sponsor: University Health Network, Toronto
Organization:

Study Overview

Official Title: 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
Status: UNKNOWN
Status Verified Date: 2022-12
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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).
Detailed Description: 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: