Mobility and Activity Patterns in Hospitalised Severe Brain Injury (MAP-ABI)

March 11, 2024 updated by: Christian Riberholt

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Department of brain and spinal cord injury

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acquired brain injury of any cause admitted for rehabilitation at the department will be recruited.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Activity monitor group
No intervention will be applied. All included patients will be monitored with body-worn physical activity monitors during two periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Continuous measure of physical activity during day three to ten of rehabilitation

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications during rehabilitation
Time Frame: Rehabilitation period (3 months)
Registration of the number of complications during rehabilitation stay at hospital (e.g. pneumonia, unrinary infection, hydrocephalus etc). Predefined in protocol.
Rehabilitation period (3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christian Riberholt

Collaborators

SENS Innovation Aps

Investigators

  • Principal Investigator: Vibeke Wagner, MsC, Rigshospitalet, Department of Brain and Spinal Cord Injury

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2022

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-22031667

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data that are truly anonymised will be uploaded to Zenodo after the publication of the study. Data that we are not able to truly anonymise will be available upon reasonable request.

IPD Sharing Time Frame

Two years after study completion. Data will be available for at least ten years.

IPD Sharing Access Criteria

Any researcher can make contact to primary investigator or sponsor with pre-planned project description.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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