Acute Brain InjuryFOOBScan2NCT07548580
Physical Mobilisation to Acquired Brain Injury Patients in Intensive Care Units: a Prospective Cohort Study
An observational study of Acute Brain Injury, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
The objective of this study is to quantify the amount of physical mobilisation provided to patients with moderate to severe acquired brain injury in Scandinavian neuro-ICs, and the association between intensity and duration of mobilisation, physiological data perceived to be related to the safety of high-level… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury
- How many people
- 198 participants
- Where
- 2 sitesDenmark
- Study dates
- 25 Aug 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to a neuro-ICU or to a regular ICU due to moderate to severe traumatic brain injury or stroke.
Who may be able to join
- Adults (age ≥ 18 years)
- Admitted to a neuro-ICU or to a regular ICU with dedicated beds for severe acquired brain injury patients in Scandinavia
- Patients with moderate to severe traumatic brain injury (TBI) or stroke
- Patients must be intubated and expected to require mechanically ventilation for at least 24 hours.
Who cannot join
- Patients that are not likely to survive or for whom a decision has been made on palliative care.
- Patients allergic to the Sens monitor patch or showing any type of allergic reactions from the patch after inclusion in the study that needs treatments or results in immediately removal of the patch.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen
Christian Gunge Riberholt, PhD, 0045-38631600, christian.gunge.riberholt@regionh.dk
- Active, not recruiting
Odense Universitets Hospital
Odense
About this study
Official title: Describing the Physical Mobilisation Provided to Patients With Acquired Brain Injury in Intensive Care Units: Protocol for a Prospective Cohort Study
The objective of this study is to quantify the amount of physical mobilisation provided to patients with moderate to severe acquired brain injury in Scandinavian neuro-ICs, and the association between intensity and duration of mobilisation, physiological data perceived to be related to the safety of high-level mobilisation, and amount of high-level mobilisation during the neuro-ICU stay.
Read the detailed description
In patients with severe acute brain injury (SABI) admitted to neurointensive care units (neuro-ICU), sedation and, consequently, immobilisation are applied to minimize intracranial complications such as increased intracranial pressure and metabolic crisis. However, complications associated to this immobilisation are of major concern. Physical inactivity has been demonstrated to have a negative impact on health in several studies and is accepted as a health threat in the general population.
For patients in neuro-ICUs with severe traumatic brain injury or acute stroke, both inactivity and high levels of inflammatory markers are associated with an increased risk of developing deep vein thrombosis. As an attempt to minimise inactivity-related complications, earlier onset of out-of-bed mobilisation in ICUs has gained increased interest, but the evidence for effect is small and inconclusive and does not address intensity.
The primary objective of this study is to quantify the amount of physical mobilisation provided to patients with moderate to severe acquired brain injury in Scandinavian neuro-ICUs, and the association between intensity and duration of mobilisation, physiological data perceived to be related to the safety of high-level mobilisation (as defined under Monitoring physical activity below), and amount of high-level mobilisation during the neuro-ICU stay. As secondary objectives, we aim to explore the association between the frequency of high-level mobilisation sessions during the neuro-ICU stay and the outcomes indicated as relevant by clinicians in Scandinavian neuro-ICUs.
- Conditions
- Acute Brain Injury
- Keywords
- Acute brain injury, Mobilisation
- Medical subject headings
- Brain Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of physical mobilisation
Amount of physical mobilisation provided during stay at neuro-ICU
Measured: From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
Amount of high-level mobilisation
Amount of high-level mobilisation during stay at neuro-ICU
Measured: From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
Association between intensity and duration of mobilisation
The association between the intensity and duration of mobilisation during stay at neuro-ICU
Measured: From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
Secondary outcomes (1)
Association between frequency of high-level mobilisation and outcomes indicated relevant
Outcomes indicated relevant by clinicians in Scandinavian neuro-ICUs
Measured: From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start25 Aug 2025
- Primary completionJun 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Riberholt, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christian Gunge Riberholt, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548580
- Sponsor's protocol ID
- H-24084284
- Acronym
- FOOBScan2
- Status last verified
- Apr 2026
- First submitted
- 3 Sep 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Describing the Physical Mobilisation Provided to Patients With Acquired Brain Injury in Intensive Care Units: Protocol for a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07548580
- Acronym / sponsor ID
- FOOBScan2 / H-24084284
- Conditions
- Acute Brain Injury
- Keywords
- Acute brain injury, Mobilisation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to quantify the amount of physical mobilisation provided to patients with moderate to severe acquired brain injury in Scandinavian neuro-ICs, and the association between intensity and duration of mobilisation, physiological data perceived to be related to the safety of high-level mobilisation, and amount of high-level mobilisation during the neuro-ICU stay.
Detailed description
In patients with severe acute brain injury (SABI) admitted to neurointensive care units (neuro-ICU), sedation and, consequently, immobilisation are applied to minimize intracranial complications such as increased intracranial pressure and metabolic crisis. However, complications associated to this immobilisation are of major concern. Physical inactivity has been demonstrated to have a negative impact on health in several studies and is accepted as a health threat in the general population.
For patients in neuro-ICUs with severe traumatic brain injury or acute stroke, both inactivity and high levels of inflammatory markers are associated with an increased risk of developing deep vein thrombosis. As an attempt to minimise inactivity-related complications, earlier onset of out-of-bed mobilisation in ICUs has gained increased interest, but the evidence for effect is small and inconclusive and does not address intensity.
The primary objective of this study is to quantify the amount of physical mobilisation provided to patients with moderate to severe acquired brain injury in Scandinavian neuro-ICUs, and the association between intensity and duration of mobilisation, physiological data perceived to be related to the safety of high-level mobilisation (as defined under Monitoring physical activity below), and amount of high-level mobilisation during the neuro-ICU stay. As secondary objectives, we aim to explore the association between the frequency of high-level mobilisation sessions during the neuro-ICU stay and the outcomes indicated as relevant by clinicians in Scandinavian neuro-ICUs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to a neuro-ICU or to a regular ICU due to moderate to severe traumatic brain injury or stroke.
Key inclusion criteria (4 listed)
- Adults (age ≥ 18 years)
- Admitted to a neuro-ICU or to a regular ICU with dedicated beds for severe acquired brain injury patients in Scandinavia
- Patients with moderate to severe traumatic brain injury (TBI) or stroke
- Patients must be intubated and expected to require mechanically ventilation for at least 24 hours.
Key exclusion criteria (2 listed)
- Patients that are not likely to survive or for whom a decision has been made on palliative care.
- Patients allergic to the Sens monitor patch or showing any type of allergic reactions from the patch after inclusion in the study that needs treatments or results in immediately removal of the patch.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amount of physical mobilisation
Time frame: From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
Amount of physical mobilisation provided during stay at neuro-ICU
Amount of high-level mobilisation
Time frame: From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
Amount of high-level mobilisation during stay at neuro-ICU
Association between intensity and duration of mobilisation
Time frame: From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
The association between the intensity and duration of mobilisation during stay at neuro-ICU
1 secondary outcome
Association between frequency of high-level mobilisation and outcomes indicated relevant
Time frame: From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Brain Injury
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Gunge Riberholt, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Brain Injury, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Gunge Riberholt, PhD (0045-38631600, christian.gunge.riberholt@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of physical mobilisation (time frame: From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.