Mobility and Activity Patterns in Hospitalised Severe Brain Injury

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Brain Injuries

Intervention / Treatment
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* Other: Activity monitor group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Activity monitor group<br>No intervention will be applied. All patients will have activity monitors placed at the distal part of the femur and on the torso. Normal rehabilitation will be performed as usual. | Other: Activity monitor group<br>* No intervention will be applied. All included patients will be monitored with body-worn physical activity monitors during two periods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early physical activity | Activity data collected in the early phase will be the exposure variable. Amount of minutes patients are physically active. | Continuous measure of physical activity during day three to ten of rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late physical activity | Activity data collected in the early phase will be the exposure variable. Amount of minutes patients are physically active. | Continuous measure of physical activity during day three to ten before discharge from rehabilitation | 
| Functional Independence Measure (discharge) | Functional scale evaluating independence from a score of 18 (worst) to 126 (best) | Discharge from rehabilitation (3 months) | 
| Glasgow Coma Scale (GCS) (admission) | Coma scale with score between 3 (worst) to 15 (best) | Admission | 
| Comorbidities at admission | Number of comorbidities | Admission | 
| Early Functional Ability (EFA) score | Early signs of functional ability. Score between 20 (worst) and 100 (best) | Admission | 
| Ranchos Los Amigos Score | Level of cognitive function. Score between 1 (worst) and 8 (best) | Admission | 
| Length of stay at intensive care unit | Number of days at intensive care unit before admission to rehabilitation unit | Retrospectively recorded at admission to the rehabilitation department | 
| Agitated Behaviour Scale (ABS) | Days with ABS above 22. Dichotomised outcome with scores above 22 indicating agitated behaviour. | Day three to ten of rehabilitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Physical activity