Study Results
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Basic Information
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NOT_YET_RECRUITING
140 participants
OBSERVATIONAL
2026-01-01
2030-12-31
Brief Summary
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Detailed Description
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Denmark currently lacks a comprehensive national guideline for managing concussions within regional and municipal healthcare systems. As a result, individuals with concussions are often left to navigate the healthcare system on their own, leading to limited or no access to rehabilitation services. The Danish Center for Concussion and other experts have recommended the establishment of national concussion clinics.
Since 2016, the Special Education and Employment Unit (SuB) in Slagelse, part of the municipality's Center for Disability and Psychiatry, has been developing and providing concussion interventions based on national and international evidence. Participants in these programs have reported significant improvements in weekly work hours and overall quality of life. However, the long-term effects of these interventions remain unknown.
Participants are typically in great distress and need help, which is why a lack of interventions-or the delay of interventions for several months-in a control group is considered unethical. It should be noted that single-group studies, which evaluate outcomes longitudinally, are often the only possible method and can provide both interesting and reliable results. Investigators will be blinded for participants being allocated to early or late interventions.
This single-center and uncontrolled study aims to investigate the long-term impact of interdisciplinary and personalized concussion rehabilitation programs on quality of life and work capacity. Researchers will compare the outcomes of individuals who begin the program within 1-3 months post-concussion to those who start later (more than 9 months post-concussion) to determine the significance of early intervention. This research is groundbreaking as it will provide valuable insights into the long-term effects of concussions and the importance of timely interventions.
Aim: To evaluate the effectiveness of tailored concussion rehabilitation programs.
Outcomes: Changes in quality of life and work capacity. Timeframes: Immediate post-program and at 1 and 3 years. Comparison: Early vs. late intervention. Significance: The study will fill a gap in the current understanding of concussion recovery.
In essence, this study seeks to determine if a comprehensive and individualized approach to concussion rehabilitation can lead to sustained improvements in the lives of those affected, and whether starting treatment sooner is beneficial.
The investigators expect that an early intervention will result in significantly higher average weekly work hours and quality of life compared to a late intervention. The main hypothesis is that an early intervention will counteract the chronic effects and prevent worsening, including by inhibiting the development of hypersensitivity to sound and light.
The vision is to offer an intervention for concussion sufferers at the highest international level, and with this focus, it is important to know the long-term effects.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Early intervention
Interventions for mTBI patients initiated within 1 to 3 months after symptoms onset:
Interventions include psychoeducation for the individual, their family, and their workplace or educational setting. Investigators initiate contact with the individual's workplace or educational setting to discuss the case and collaborate closely with both the individual and their employer/supervisor. Investigators focus on vocational rehabilitation, aiming to gradually increase the participant's work capacity, weekly working hours, and job retention. Ongoing supportive conversations are provided before and during work or study. Investigators offer counseling on cognitive and psychological aspects, with a focus on mental health.
All interventions focus on gradual progression, exposure, and rehabilitation in both personal and work life. Participants are guided in gradually increasing activities and working hours.
Psychoeducation
Focus on understanding mechanisms of concussion
Physiotherapy
Gradual training and physical exercises
Treatment of tinnitus and increased sound sensitivity
Treatment given individually or in groups
Vision training and examination
Training and examination by a neuro-optometrist
Sleep guidance and education
Counselling to achieve better sleep and reduce fatigue.
Mindfulness with a cognitive therapeutic approach
Training by certified mindfulness instructor
Employment-oriented intervention
The Concussion Team therapists work with a patient's employer to facilitate a gradual return to normal working hours.
Energy management and graded exercise
Counselling to achieve more energy and vitality.
Neuropsychological counseling
Talks with a neuropsychologist about mTBI sequelae.
Late intervention
Interventions for mTBI patients initiated at least 9 months after symptoms onset. Note that these interventions are the same as offered to the early interventions group:
Interventions include psychoeducation for the individual, their family, and their workplace or educational setting. Investigators initiate contact with the individual's workplace or educational setting to discuss the case and collaborate closely with both the individual and their employer/supervisor. Investigators focus on vocational rehabilitation, aiming to gradually increase the participant's work capacity, weekly working hours, and job retention. Ongoing supportive conversations are provided before and during work or study. Investigators offer counseling on cognitive and psychological aspects, with a focus on mental health.
All interventions focus on gradual progression, exposure, and rehabilitation in both personal and work life. Participants are guided in gradually increasing activities and working hours.
Psychoeducation
Focus on understanding mechanisms of concussion
Physiotherapy
Gradual training and physical exercises
Treatment of tinnitus and increased sound sensitivity
Treatment given individually or in groups
Vision training and examination
Training and examination by a neuro-optometrist
Sleep guidance and education
Counselling to achieve better sleep and reduce fatigue.
Mindfulness with a cognitive therapeutic approach
Training by certified mindfulness instructor
Employment-oriented intervention
The Concussion Team therapists work with a patient's employer to facilitate a gradual return to normal working hours.
Energy management and graded exercise
Counselling to achieve more energy and vitality.
Neuropsychological counseling
Talks with a neuropsychologist about mTBI sequelae.
Interventions
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Psychoeducation
Focus on understanding mechanisms of concussion
Physiotherapy
Gradual training and physical exercises
Treatment of tinnitus and increased sound sensitivity
Treatment given individually or in groups
Vision training and examination
Training and examination by a neuro-optometrist
Sleep guidance and education
Counselling to achieve better sleep and reduce fatigue.
Mindfulness with a cognitive therapeutic approach
Training by certified mindfulness instructor
Employment-oriented intervention
The Concussion Team therapists work with a patient's employer to facilitate a gradual return to normal working hours.
Energy management and graded exercise
Counselling to achieve more energy and vitality.
Neuropsychological counseling
Talks with a neuropsychologist about mTBI sequelae.
Eligibility Criteria
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Inclusion Criteria
* Adults with a connection to the labor market.
* Participants must be able to communicate in Danish and be able to independently participate in the intervention.
* Participants must be able to transport themsleves to and from SuB facility for their treatment sessions.
* Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score must be at least 20, indicating a significant severity of symptoms following a concussion.
Exclusion Criteria
* Person where brain injury was found at symptom onset.
* Persons with significant cognitive dysfunction.
* Persons who are unable to understand Danish or with communication disorders that hinder test performance.
* Persons with terminal illness or other progressive disease.
* Chronic use of opioids.
* Significant abuse of alcohol or euphoriants or narcotics or other serious illnesses that may affect test results or ability/possibility of attendance.
18 Years
ALL
No
Sponsors
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Special Education and Employment Unit (SuB) in Slagelse, part of the municipality's Center for Disability and Psychiatry
UNKNOWN
Danish Center for Concussion
UNKNOWN
Rune Skovgaard Rasmussen
OTHER
Responsible Party
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Rune Skovgaard Rasmussen
MSc, Ph.D., associate professor
Principal Investigators
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Rune S Rasmussen, MSc, PhD
Role: STUDY_DIRECTOR
Special Education and Employment Unit (SuB) in Slagelse
Signe E Petersson, OT
Role: STUDY_CHAIR
Special Education and Employment Unit (SuB) in Slagelse
Central Contacts
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Other Identifiers
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12292024
Identifier Type: -
Identifier Source: org_study_id
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