Actively Recruiting
Get Going After concussIonN Lite
Led by University of Aarhus · Updated on 2025-04-02
100
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
H
Hammel Neurorehabilitation Centre and University Research Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Get Going After concussIonN Lite
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Concussion caused by a head trauma with direct contact between head and object as defined by Danish Consensus Report on Commotio Cerebri
- Age between 18 and 60 years at time of concussion
- Rivermead Post-concussion Questionnaire (RPQ) score between 10 and 30 within 1 week before enrollment
- Able to understand, speak, and read Danish
- Living in the Central Denmark Region
- Identified from emergency department records or referred by general practitioners within 2-4 months after concussion
You will not qualify if you...
- Neurological findings or acute trauma CT scan showing brain damage related to concussion, if performed
- Previous concussion within last 2 years with ongoing post-concussion symptoms at time of current concussion
- Severe misuse of alcohol, prescription drugs, or illegal drugs
- Severe psychiatric disorders (e.g., bipolar disorder, autism, psychotic disorder) or severe neurological disease (e.g., multiple sclerosis) that prevent participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hammel Neurorehabilitation Centre and University Research Clinic
Hammel, Deb´nmark, Denmark, 8450
Actively Recruiting
Research Team
S
Sedsel Pedersen, PhD student
CONTACT
I
Iris Brunner, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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