Physical Mobilisation to Acquired Brain Injury Patients in Intensive Care Units: a Prospective Cohort Study

Describing the Physical Mobilisation Provided to Patients With Acquired Brain Injury in Intensive Care Units: Protocol for a Prospective Cohort Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07548580

Acronym

FOOBScan2

Enrollment

198

Registered

2026-04-23

Start date

2025-08-25

Completion date

2027-01-01

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Brain Injury

Keywords

Acute brain injury, Mobilisation

Brief 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 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Amount of physical mobilisation	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	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	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

Secondary

Measure	Time frame	Description
Association between frequency of high-level mobilisation and outcomes indicated relevant	From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.	Outcomes indicated relevant by clinicians in Scandinavian neuro-ICUs

Countries

Denmark

Contacts

CONTACTChristian Gunge Riberholt, PhD

christian.gunge.riberholt@regionh.dk0045-38631600

PRINCIPAL_INVESTIGATORChristian Gunge Riberholt, PhD

Rigshospitalet, Denmark

Outcome results