Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT05233475

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

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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

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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