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NCT Number: NCT07548580

Physical Mobilisation to Acquired Brain Injury Patients in Intensive Care Units: 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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.

    Outcomes indicated relevant by clinicians in Scandinavian neuro-ICUs

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Gunge Riberholt, PhD

CONTACT

[email protected]

0045-38631600

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Acronym: FOOBScan2

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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