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Clinical Trials/NCT05571462
NCT05571462
Active, Not Recruiting
N/A

Mobility and Activity Patterns in Hospitalised Patients With Severe Acquired Brain Injury Undergoing Rehabilitation. The MAP-study.

Christian Riberholt1 site in 1 country100 target enrollmentNovember 3, 2022
ConditionsBrain Injuries

Overview

Phase
N/A
Intervention
Not specified
Conditions
Brain Injuries
Sponsor
Christian Riberholt
Enrollment
100
Locations
1
Primary Endpoint
Early physical activity
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 3, 2022
End Date
April 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Christian Riberholt
Responsible Party
Sponsor Investigator
Principal Investigator

Christian Riberholt

Principal investigator

Rigshospitalet, Denmark

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

Outcomes

Primary Outcomes

Early physical activity

Time Frame: Continuous measure of physical activity during day three to ten of rehabilitation

Activity data collected in the early phase will be the exposure variable. Amount of minutes patients are physically active.

Secondary Outcomes

  • Late physical activity(Continuous measure of physical activity during day three to ten before discharge from rehabilitation)
  • Early Functional Ability (EFA) score(Admission)
  • Glasgow Coma Scale (GCS) (admission)(Admission)
  • Agitated Behaviour Scale (ABS)(Day three to ten of rehabilitation)
  • Functional Independence Measure (discharge)(Discharge from rehabilitation (3 months))
  • Comorbidities at admission(Admission)
  • Ranchos Los Amigos Score(Admission)
  • Length of stay at intensive care unit(Retrospectively recorded at admission to the rehabilitation department)

Study Sites (1)

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