Get Going After concussIonN Lite
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Enhanced usual care (EUC)
- Get Going after concussIoN Lite
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Aarhus
Lead sponsor
Hammel Neurorehabilitation Centre and University Research Clinic
Collaborator
Health Research Foundation of Central Denmark Region
Collaborator
Source ClinicalTrials.gov