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

Sponsor
Christian Riberholt (Other)
Overall Status
Recruiting
CT.gov ID
NCT05571462
Collaborator
SENS Innovation Aps (Other)
100
Enrollment
1
Location
16.9
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Activity monitor group

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Mobility and Activity Patterns in Hospitalised Patients With Severe Acquired Brain Injury Undergoing Rehabilitation. The MAP-study.
Actual Study Start Date :
Nov 3, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. Functional Independence Measure (discharge) [Discharge from rehabilitation (3 months)]

    Functional scale evaluating independence from a score of 18 (worst) to 126 (best)

  3. Glasgow Coma Scale (GCS) (admission) [Admission]

    Coma scale with score between 3 (worst) to 15 (best)

  4. Comorbidities at admission [Admission]

    Number of comorbidities

  5. Early Functional Ability (EFA) score [Admission]

    Early signs of functional ability. Score between 20 (worst) and 100 (best)

  6. Ranchos Los Amigos Score [Admission]

    Level of cognitive function. Score between 1 (worst) and 8 (best)

  7. 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

  8. Agitated Behaviour Scale (ABS) [Day three to ten of rehabilitation]

    Days with ABS above 22. Dichotomised outcome with scores above 22 indicating agitated behaviour.

Other Outcome Measures

  1. Complications during rehabilitation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Brain and Spinal Cord Injury Hvidovre Denmark 2650

Sponsors and Collaborators

  • Christian Riberholt
  • SENS Innovation Aps

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Christian Riberholt, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT05571462
Other Study ID Numbers:
  • H-22031667
First Posted:
Oct 7, 2022
Last Update Posted:
Nov 8, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christian Riberholt, Principal investigator, Rigshospitalet, Denmark
Exercise
Physical activity
Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries

Study Results

No Results Posted as of Nov 8, 2022