Get Going After concussIonN Lite (NCT05233475) | Clinical Trial Compass
RecruitingNot Applicable
Get Going After concussIonN Lite
Denmark100 participantsStarted 2023-02-13
Plain-language summary
Background:
Concussion affects around 25 000 people each year in Denmark. A large research initiative (GAIN 2.0) has been established, and the current study is a part of this initiative.
Aims:
1. To develop and test the efficacy of a novel intervention for people with persistent post-concussional mild-to-moderate symptoms: "Get going After concussion Lite" (GAIN Lite).
2. To increase the knowledge about the target group by investigating the association of physical activity, digital behaviour, and symptom load.
Methods:
A randomized controlled trial, comparing GAIN Lite to enhanced usual care. 100 adults diagnosed with a concussion at hospitals in Central Denmark Region or referred from general practitioners will be recruited. GAIN Lite is a digital intervention, and the primary outcome is the severity of post-concussional symptoms. A prospective cohort study will be performed to investigate the association between physical activity, cognitive processing, and symptom load.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri (26). The criteria are based on recommendations by the WHO Task Force, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out acceleration - deceleration traumas;
. Age 18 to 60 years at the time of the trauma;
. A total score of 10-30 on RPQ within 1 week before enrolment in the study;
. Able to understand, speak and read Danish;
. Living in Central Denmark Region;
. Identified from registers of the emergency departments or referred by GPs to GAIN Lite within 2-4 months after a concussion
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rivermead Post-concussion Questionnaire (RPQ/DK)
Timeframe: 6 months: From baseline to 24 weeks after baseline
2
Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P/DK)
Timeframe: 6 months: From baseline to 24 weeks after baseline
. Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage linked to the concussion, if performed;
. Previous concussion within the last 2 years with ongoing PCS at the time of the present concussion
. Severe misuse of alcohol, prescription drugs and/or illegal drugs
. Severe psychiatric co-morbidity (e.g. bipolar disorder, autism, psychotic disorder (life time)) or severe neurological disease (e.g. multiple sclerosis) that impedes participation in the programme.