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 range18 Years – 60 Years
SexALL
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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
✕. 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
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
✕. 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.