Persistent post-concussion symptoms (PPCS) Injury, Occupational Diseases, Poisoning
Conditions
Interventions
The present study, conducted between January 2023 and March 2024 at Cervello in Roskilde, Denmark, is a single-blind randomized controlled 2 x 2 cross over trial adhering to the CONSORT criteria of ra
Sponsors
Offerfonden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals who have sustained a concussion, defined in this study as resulting from a traumatic event involving a direct blow to the head, or a jolt capable of causing movement of the brain inside the skull, in conjunction with at least one of the following: 1.1. Brief loss of consciousness (up to 30 minutes) 1.2. Amnesia before or after the event (up to 24 hours post-trauma) 1.3. Altered consciousness during the trauma (such as confusion or disorientation) 1.4. Transient neurological symptoms, or 1.5. A Glasgow Coma Scale (GCS) score of no less than 13 at 30 minutes, which corresponds to a diagnosis of mild traumatic brain injury meeting the ICD-10 classification for concussion (S06.0X0A) within the last 3 months. 2. Participants must be between the ages of 18 and 65 years. 3. Participants must be motivated to engage in physical training and demonstrate a willingness to follow the exercise protocols. 4. They must be able to speak and understand Danish.
Exclusion criteria
Exclusion criteria: 1. GCS less than 13 at 30 minutes after injury 2. Individuals with severe psychiatric disorders. 3. Individuals with any pre-existing physical or psychological disability or other conditions that would prevent participation in physical training. 4. Those experiencing severe vestibular (balance) or oculomotor (vision) difficulties that would inhibit their ability to train due to conditions other than concussion/mTBI (e.g., cancer, poisoning, infectious diseases). 5. Pregnant women. 6. Individuals currently using prescription medications that could interfere with visual and vestibular function. 7. Participants with blood pressure readings above 160/100. 8. Participants were permitted to continue with necessary specialized treatments, such as manual therapy for neck-related issues, during the study period. However, they were not allowed to engage in additional physical training outside the study protocol. If any participant began other specialized physical treatments or exercises during the project period, they were excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Persistent post-concussion symptoms measured using the Rivermead Post Concussion Questionnaire at four timepoints: 1. Before randomisation into the two groups 2. After 8 weeks of intervention treatment/sham treatment (which is also the start of washout) 3. After the washout, which is after 4-6 weeks, which also marks the beginning of the cross-over intervention/sham treatment 4. After an additional 8 weeks at the conclusion of the intervention/sham treatment after crossover | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Buffalo concussion treadmill test measured in minutes to cessation 2. Postural Sway (95% CEA) measured using a KINVENT DELTA forceplate and software Measured at four timepoints: 1. Before randomisation into the two groups 2. After 8 weeks of intervention treatment/sham treatment (which is also the start of washout) 3. After the washout, which is after 4-6 weeks, which also marks the beginning of the cross-over intervention/sham treatment 4. After an additional 8 weeks at the conclusion of the intervention/sham treatment after crossover | — |
Countries
Denmark
Contacts
Public ContactKenneth Jay
Outcome results
None listed