Mobility and Activity Patterns in Hospitalised Severe Brain Injury

Active, not recruiting

• Conditions: Brain Injuries
• Interventions: Other: Activity monitor group

• Registration Number: NCT05571462
• Lead Sponsor: Christian Riberholt

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.

Study Timeline

• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-07
• Study Start: 2022-11-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Activity monitor group	Activity monitor group	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.

Primary Outcome Measures

Name	Time	Method
Early physical activity	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 Outcome Measures

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

Trial Locations

Locations (1)

Department of Brain and Spinal Cord Injury; 🇩🇰 Glostrup, Denmark