NCT07548580

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Aug 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Aug 2025Jan 2027

Study Start

First participant enrolled

August 25, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

September 3, 2025

Last Update Submit

April 21, 2026

Conditions

Keywords

Acute brain injuryMobilisation

Outcome Measures

Primary Outcomes (3)

  • Amount of physical mobilisation

    Amount of physical mobilisation provided during stay at neuro-ICU

    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

    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

    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

    From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients admitted to a neuro-ICU or to a regular ICU due to moderate to severe traumatic brain injury or stroke.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients that are not likely to survive or for whom a decision has been made on palliative care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Odense Universitets Hospital

Odense, Denmark

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Christian Gunge Riberholt, PhD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Gunge Riberholt, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher PhD

Study Record Dates

First Submitted

September 3, 2025

First Posted

April 23, 2026

Study Start

August 25, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations