Brain InjuriesMAP-ABINCT05571462
Mobility and Activity Patterns in Hospitalised Severe Brain Injury
An observational study of Brain Injuries, run by Christian Riberholt at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Activity monitor group
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Nov 2022to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acquired brain injury of any cause admitted for rehabilitation at the department will be recruited.
Who may be able to join
- 18 years old
Who cannot join
- Planned discharge within two weeks
- Fractures of lower extremities, pelvis or spine prohibiting weight-bearing
- Amputation of lower extremities
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Brain and Spinal Cord Injury
Glostrup Municipality, 2600
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Injuries
- Being tested
- Activity monitor group
- Keywords
- Exercise, Physical activity
- Medical subject headings
- Brain Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity monitor groupOther
No intervention will be applied. All included patients will be monitored with body-worn physical activity monitors during two periods.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Activity monitor group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early physical activity
Activity data collected in the early phase will be the exposure variable. Amount of minutes patients are physically active.
Measured: Continuous measure of physical activity during day three to ten of rehabilitation
Secondary outcomes (8)
Late physical activity
Activity data collected in the early phase will be the exposure variable. Amount of minutes patients are physically active.
Measured: 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)
Measured: Discharge from rehabilitation (3 months)
Glasgow Coma Scale (GCS) (admission)
Coma scale with score between 3 (worst) to 15 (best)
Measured: Admission
Comorbidities at admission
Number of comorbidities
Measured: Admission
Early Functional Ability (EFA) score
Early signs of functional ability. Score between 20 (worst) and 100 (best)
Measured: Admission
Ranchos Los Amigos Score
Level of cognitive function. Score between 1 (worst) and 8 (best)
Measured: Admission
Length of stay at intensive care unit
Number of days at intensive care unit before admission to rehabilitation unit
Measured: 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.
Measured: Day three to ten of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start3 Nov 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Riberholt
- Sponsor type
- University, hospital or other
- Collaborators
- SENS Innovation Aps
- Responsible party
- Sponsor-investigator, Christian Riberholt, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Vibeke Wagner, MsC, Principal investigator, Rigshospitalet, Department of Brain and Spinal Cord Injury
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571462
- Sponsor's protocol ID
- H-22031667
- Acronym
- MAP-ABI
- Status last verified
- Mar 2024
- First submitted
- 29 Sep 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Okely AD, Kontsevaya A, Ng J, Abdeta C. 2020 WHO guidelines on physical activity and sedentary behavior. Sports Med Health Sci. 2021 May 14;3(2):115-118. doi: 10.1016/j.smhs.2021.05.001. eCollection 2021 Jun.
PubMed 35782159Zeiler SR, Krakauer JW. The interaction between training and plasticity in the poststroke brain. Curr Opin Neurol. 2013 Dec;26(6):609-16. doi: 10.1097/WCO.0000000000000025.
PubMed 24136129Nielsen JB, Willerslev-Olsen M, Christiansen L, Lundbye-Jensen J, Lorentzen J. Science-based neurorehabilitation: recommendations for neurorehabilitation from basic science. J Mot Behav. 2015;47(1):7-17. doi: 10.1080/00222895.2014.931273.
PubMed 25575219Larsen RT, Wagner V, Korfitsen CB, Keller C, Juhl CB, Langberg H, Christensen J. Effectiveness of physical activity monitors in adults: systematic review and meta-analysis. BMJ. 2022 Jan 26;376:e068047. doi: 10.1136/bmj-2021-068047.
PubMed 35082116Ferguson T, Olds T, Curtis R, Blake H, Crozier AJ, Dankiw K, Dumuid D, Kasai D, O'Connor E, Virgara R, Maher C. Effectiveness of wearable activity trackers to increase physical activity and improve health: a systematic review of systematic reviews and meta-analyses. Lancet Digit Health. 2022 Aug;4(8):e615-e626. doi: 10.1016/S2589-7500(22)00111-X.
PubMed 35868813von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008.
PubMed 18313558Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Epidemiology. 2007 Nov;18(6):805-35. doi: 10.1097/EDE.0b013e3181577511.
PubMed 18049195Pedersen BS, Kristensen MT, Josefsen CO, Lykkegaard KL, Jonsson LR, Pedersen MM. Validation of Two Activity Monitors in Slow and Fast Walking Hospitalized Patients. Rehabil Res Pract. 2022 May 16;2022:9230081. doi: 10.1155/2022/9230081. eCollection 2022.
PubMed 35615755Riberholt CG, Wagner V, Lindschou J, Gluud C, Mehlsen J, Moller K. Early head-up mobilisation versus standard care for patients with severe acquired brain injury: A systematic review with meta-analysis and Trial Sequential Analysis. PLoS One. 2020 Aug 13;15(8):e0237136. doi: 10.1371/journal.pone.0237136. eCollection 2020.
PubMed 32790771Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476Kramer SF, Hung SH, Brodtmann A. The Impact of Physical Activity Before and After Stroke on Stroke Risk and Recovery: a Narrative Review. Curr Neurol Neurosci Rep. 2019 Apr 22;19(6):28. doi: 10.1007/s11910-019-0949-4.
PubMed 31011851Fini NA, Bernhardt J, Said CM, Billinger SA. How to Address Physical Activity Participation After Stroke in Research and Clinical Practice. Stroke. 2021 Jun;52(6):e274-e277. doi: 10.1161/STROKEAHA.121.034557. Epub 2021 May 6. No abstract available.
PubMed 33951930Adey-Wakeling Z, Jolliffe L, O'Shannessy E, Hunter P, Morarty J, Cameron ID, Liu E, Lannin NA. Activity, Participation, and Goal Awareness After Acquired Brain Injury: A Prospective Observational Study of Inpatient Rehabilitation. Ann Rehabil Med. 2021 Dec;45(6):413-421. doi: 10.5535/arm.21034. Epub 2021 Dec 31.
PubMed 35000366Norvang OP, Hokstad A, Taraldsen K, Tan X, Lydersen S, Indredavik B, Askim T. Correction to: Time spent lying, sitting, and upright during hospitalization after stroke: a prospective observation study. BMC Neurol. 2019 Jan 11;19(1):8. doi: 10.1186/s12883-018-1226-x.
PubMed 30634934Kjeldsen SS, Brodal L, Brunner I. Activity and rest in patients with severe acquired brain injury: an observational study. Disabil Rehabil. 2022 Jun;44(12):2744-2751. doi: 10.1080/09638288.2020.1844317. Epub 2020 Nov 8.
PubMed 33161752
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobility and Activity Patterns in Hospitalised Patients With Severe Acquired Brain Injury Undergoing Rehabilitation. The MAP-study.
- ClinicalTrials.gov ID
- NCT05571462
- Acronym / sponsor ID
- MAP-ABI / H-22031667
- Conditions
- Brain Injuries
- Keywords
- Exercise, Physical activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Christian RiberholtUniversity, hospital or other
- Collaborators
- SENS Innovation Aps
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activity monitor group | – | Other: Activity monitor groupNo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acquired brain injury of any cause admitted for rehabilitation at the department will be recruited.
Key inclusion criteria (1 listed)
- 18 years old
Key exclusion criteria (3 listed)
- Planned discharge within two weeks
- Fractures of lower extremities, pelvis or spine prohibiting weight-bearing
- Amputation of lower extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity monitor groupNo intervention will be applied. All included patients will be monitored with body-worn physical activity monitors during two periods. | Other | Activity monitor group |
Primary outcome
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.
8 secondary outcomes
Late physical activity
Time frame: 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)
Glasgow Coma Scale (GCS) (admission)
Time frame: Admission
Comorbidities at admission
Time frame: Admission
Early Functional Ability (EFA) score
Time frame: Admission
Ranchos Los Amigos Score
Time frame: Admission
Length of stay at intensive care unit
Time frame: Retrospectively recorded at admission to the rehabilitation department
Agitated Behaviour Scale (ABS)
Time frame: Day three to ten of rehabilitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 35782159Okely AD, Kontsevaya A, Ng J, Abdeta C. 2020 WHO guidelines on physical activity and sedentary behavior. Sports Med Health Sci. 2021 May 14;3(2):115-118. doi: 10.1016/j.smhs.2021.05.001. eCollection 2021 Jun.
- Background: PubMed 24136129Zeiler SR, Krakauer JW. The interaction between training and plasticity in the poststroke brain. Curr Opin Neurol. 2013 Dec;26(6):609-16. doi: 10.1097/WCO.0000000000000025.
- Background: PubMed 25575219Nielsen JB, Willerslev-Olsen M, Christiansen L, Lundbye-Jensen J, Lorentzen J. Science-based neurorehabilitation: recommendations for neurorehabilitation from basic science. J Mot Behav. 2015;47(1):7-17. doi: 10.1080/00222895.2014.931273.
- Background: PubMed 35082116Larsen RT, Wagner V, Korfitsen CB, Keller C, Juhl CB, Langberg H, Christensen J. Effectiveness of physical activity monitors in adults: systematic review and meta-analysis. BMJ. 2022 Jan 26;376:e068047. doi: 10.1136/bmj-2021-068047.
- Background: PubMed 35868813Ferguson T, Olds T, Curtis R, Blake H, Crozier AJ, Dankiw K, Dumuid D, Kasai D, O'Connor E, Virgara R, Maher C. Effectiveness of wearable activity trackers to increase physical activity and improve health: a systematic review of systematic reviews and meta-analyses. Lancet Digit Health. 2022 Aug;4(8):e615-e626. doi: 10.1016/S2589-7500(22)00111-X.
- Background: PubMed 18313558von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008.
- Background: PubMed 18049195Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Epidemiology. 2007 Nov;18(6):805-35. doi: 10.1097/EDE.0b013e3181577511.
- Background: PubMed 35615755Pedersen BS, Kristensen MT, Josefsen CO, Lykkegaard KL, Jonsson LR, Pedersen MM. Validation of Two Activity Monitors in Slow and Fast Walking Hospitalized Patients. Rehabil Res Pract. 2022 May 16;2022:9230081. doi: 10.1155/2022/9230081. eCollection 2022.
- Background: PubMed 32790771Riberholt CG, Wagner V, Lindschou J, Gluud C, Mehlsen J, Moller K. Early head-up mobilisation versus standard care for patients with severe acquired brain injury: A systematic review with meta-analysis and Trial Sequential Analysis. PLoS One. 2020 Aug 13;15(8):e0237136. doi: 10.1371/journal.pone.0237136. eCollection 2020.
- Background: PubMed 26092476Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Background: PubMed 31011851Kramer SF, Hung SH, Brodtmann A. The Impact of Physical Activity Before and After Stroke on Stroke Risk and Recovery: a Narrative Review. Curr Neurol Neurosci Rep. 2019 Apr 22;19(6):28. doi: 10.1007/s11910-019-0949-4.
- Background: PubMed 33951930Fini NA, Bernhardt J, Said CM, Billinger SA. How to Address Physical Activity Participation After Stroke in Research and Clinical Practice. Stroke. 2021 Jun;52(6):e274-e277. doi: 10.1161/STROKEAHA.121.034557. Epub 2021 May 6. No abstract available.
- Wagner V, Gravesen P, Ghaziani E, Olsen MH, Riberholt CG. Mapping physical activity patterns in hospitalised patients with moderate to severe acquired brain injury - MAP-ABI: Protocol for an observational study. Heliyon. 2023 Nov 8;9(11):e21927.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vibeke Wagner, MsC principal investigator
Rigshospitalet, Department of Brain and Spinal Cord Injury
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, run by Christian Riberholt at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early physical activity (time frame: Continuous measure of physical activity during day three to ten of rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05571462, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.