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Post Concussion Symptoms Risk Stratification Tool

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05664620
Enrollment
75
Registered
2022-12-27
Start date
2021-02-17
Completion date
2024-12-31
Last updated
2022-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Concussion Syndrome

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.

Interventions

DIAGNOSTIC_TESTRisk Stratification Tool

Patients will be allocated to three groups (Low,medium and high risk) by using the Risk Stratification Tool, and High risk patients will receive multidisciplinary treatment assigned to them by a physician

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Diagnostic Test: Risk Stratification Tool Patients will be allocated to three groups (Low, medium and high risk) by using the Risk Stratification Tool, and High-risk patients will receive multidisciplinary treatment assigned to them by a physician.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Age between 18-60 years old 2. Clinical diagnosis of PCS for 1-12 months with at least 3 symptoms 3. Must be employed at time of injury 4. Full-time or part-time worker prior to concussion and cannot return to work 5. Must speak English and be sufficiently literate to complete questionnaires and perform assessments 6. Must be able to give consent

Exclusion criteria

1. Abnormalities on MRI such as contusion, hemorrhages, siderosis, or other non-traumatic conditions 2. History of neurological conditions (e.g. stroke, seizures) or major psychiatric disease

Design outcomes

Primary

MeasureTime frameDescription
Return to work12 months after treatment start dayThe 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.

Secondary

MeasureTime frameDescription
Work Quality12 months after treatment start dayThe type of work returned to in relation to the pre-concussion work and work stability in terms of being able to stay working after RTW. For this purpose, a modified work quality Index (WQI) will be used.

Countries

Canada

Contacts

Primary ContactMozhgan Khodadadi, MA
mozhgan.khodadadi@uhn.ca416-603-5800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026