Early physical mobilisation for adults with moderate to severe acquired brain injury in neuro-ICUs
Official title: Describing the Physical Mobilisation Provided to Patients With Acquired Brain Injury in Intensive Care Units: Protocol for a Prospective Cohort Study
Run by Copenhagen University Hospital, Rigshospitalet · NCT07548580 · Data updated 2026-11-12
This project sees if the amount and intensity of early physical mobilisation for adults with moderate to severe acute brain injury in Scandinavian neuro-ICUs relates to safety and physiological responses.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 198 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 2 sites (Copenhagen and 1 other locations) |
| Status | Recruiting |
| Started | August 25, 2025 |
| Main results expected | June 2026 |
| Study ends | January 2027 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07548580 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with moderate to severe traumatic brain injury or stroke admitted to participating neuro-ICUs who are intubated and expected to require mechanical ventilation for at least 24 hours.
✕Probably not a fit
Patients who are not expected to survive, are receiving palliative care, have a significant allergy to the Sens monitor patch, or have milder brain injury and do not require prolonged mechanical ventilation are unlikely to benefit from this study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational cohort records physical mobilisation events for adults with moderate to severe traumatic brain injury or stroke admitted to participating neuro-ICUs. Enrolled patients are intubated and expected to require mechanical ventilation for at least 24 hours and wear a Sens activity monitor patch alongside standard ICU monitoring to capture activity intensity, duration, and physiological data. The study quantifies total and high-level mobilisation during the neuro-ICU stay and analyzes associations between mobilisation intensity/duration and physiological signals that are perceived to relate to safety. No experimental intervention is delivered; data are collected at participating Scandinavian neuro-ICUs to describe current practice and safety profiles.
Why it matters
Potential benefit: If successful, the results could identify safer timing and intensity ranges for early mobilisation to reduce immobilisation-related complications and help guide ICU practice.
How similar studies have gone: Previous ICU mobilisation research has shown mixed results and has not clearly addressed mobilisation intensity, so intensity-focused monitoring in neuro-ICU patients remains relatively untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Rigshospitalet
Copenhagen, Denmark Recruiting -
Odense Universitets Hospital
Odense, Denmark Active not recruiting
Study contacts
- Principal investigator: Christian Gunge Riberholt, PhD — Copenhagen University Hospital, Rigshospitalet
- Study coordinator: Christian Gunge Riberholt, PhD
- Email: christian.gunge.riberholt@regionh.dk
- Phone: 0045-38631600
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.