Clinical trial NCT05571462: Mobility and Activity Patterns in Hospitalised Severe Brain Injury
Official title: Mobility and Activity Patterns in Hospitalised Patients With Severe Acquired Brain Injury Undergoing Rehabilitation. The MAP-study.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Brain Injuries
Keywords: Exercise
Physical activity
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: SENS Innovation Aps
First posted: 2022-10-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acquired brain injury of any cause admitted for rehabilitation at the department will be recruited.

Brief summary: The purpose of this observational study is to quantify physical activity patterns in patients with severe acquired brain injury admitted for in-hospital rehabilitation.

Detailed description: Patients admitted for rehabilitation will be included for two periods of one-week monitorization of physical activity. The investigators will include all patients with moderate to severe brain injury.

This is an observational cross-sectional study including patients 18 years or above. Patients with conditions such as unstable fractures that restricts mobilisation are excluded. Physical activity is measured continuously during rehabilitation at two separate seven-day periods using a body-worn activity tracker. The first period will be initiated in the early phase of rehabilitation (3 days after admission) and the second at the late phase (10 days before discharge).

Baseline variables considered predictors, confounders or modifiers for physical activity will be collected along with registration of variables during the measurement periods and functional outcome variables at discharge.

Eligibility criteria: Inclusion Criteria:

* 18 years old

Exclusion Criteria:

* Planned discharge within two weeks
* Fractures of lower extremities, pelvis or spine prohibiting weight-bearing
* Amputation of lower extremities

Primary outcomes:
measure: Early physical activity
timeFrame: Continuous measure of physical activity during day three to ten of rehabilitation
Secondary outcomes:
measure: Late physical activity
timeFrame: Continuous measure of physical activity during day three to ten before discharge from rehabilitation
measure: Functional Independence Measure (discharge)
timeFrame: Discharge from rehabilitation (3 months)
measure: Glasgow Coma Scale (GCS) (admission)
timeFrame: Admission
measure: Comorbidities at admission
timeFrame: Admission
measure: Early Functional Ability (EFA) score
timeFrame: Admission
measure: Ranchos Los Amigos Score
timeFrame: Admission
measure: Length of stay at intensive care unit
timeFrame: Retrospectively recorded at admission to the rehabilitation department
measure: Agitated Behaviour Scale (ABS)
timeFrame: Day three to ten of rehabilitation
Other outcomes:
measure: Complications during rehabilitation
timeFrame: Rehabilitation period (3 months)
Locations:
city: Glostrup
country: Denmark
facility: Department of Brain and Spinal Cord Injury
Study officials:
affiliation: Rigshospitalet, Department of Brain and Spinal Cord Injury
name: Vibeke Wagner, MsC
role: PRINCIPAL_INVESTIGATOR
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