Early physical mobilisation for adults with moderate to severe acquired brain injury in neuro-ICUs
Describing the Physical Mobilisation Provided to Patients With Acquired Brain Injury in Intensive Care Units: Protocol for a Prospective Cohort Study
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 |
|---|---|
| Enrollment | 198 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 2 sites (Copenhagen and 1 other locations) |
| Trial ID | NCT07548580 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Copenhagen and 1 other locations
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Odense Universitets Hospital — Odense, Denmark (Active_not_recruiting)
Study contacts
- Principal investigator: Christian Gunge Riberholt, PhD — Rigshospitalet, Denmark
- Study coordinator: Christian Gunge Riberholt, PhD
- Email: christian.gunge.riberholt@regionh.dk
- Phone: 0045-38631600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.