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Mobility and Activity Patterns in Hospitalised Severe Brain Injury

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05571462
Acronym
MAP-ABI
Enrollment
100
Registered
2022-10-07
Start date
2022-11-03
Completion date
2024-04-30
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries

Keywords

Exercise, Physical activity

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.

Interventions

No intervention will be applied. All included patients will be monitored with body-worn physical activity monitors during two periods.

Sponsors

SENS Innovation Aps
CollaboratorUNKNOWN
Christian Riberholt
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Early physical activityContinuous measure of physical activity during day three to ten of rehabilitationActivity data collected in the early phase will be the exposure variable. Amount of minutes patients are physically active.

Secondary

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

Other

MeasureTime frameDescription
Complications during rehabilitationRehabilitation period (3 months)Registration of the number of complications during rehabilitation stay at hospital (e.g. pneumonia, unrinary infection, hydrocephalus etc). Predefined in protocol.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026