Mobility and Activity Patterns in Hospitalised Severe Brain Injury
NCT ID: NCT05571462
Last Updated: 2024-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
100 participants
OBSERVATIONAL
2022-11-03
2024-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Activity monitor group
No intervention will be applied. All included patients will be monitored with body-worn physical activity monitors during two periods.
Interventions
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Activity monitor group
No intervention will be applied. All included patients will be monitored with body-worn physical activity monitors during two periods.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Fractures of lower extremities, pelvis or spine prohibiting weight-bearing
* Amputation of lower extremities
18 Years
ALL
No
Sponsors
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SENS Innovation Aps
UNKNOWN
Christian Riberholt
OTHER
Responsible Party
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Christian Riberholt
Principal investigator
Principal Investigators
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Vibeke Wagner, MsC
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Department of Brain and Spinal Cord Injury
Locations
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Department of Brain and Spinal Cord Injury
Glostrup Municipality, , Denmark
Countries
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References
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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.
Zeiler 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.
Nielsen 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.
Larsen 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.
Ferguson 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.
von 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.
Vandenbroucke 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.
Pedersen 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.
Riberholt 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.
Whitehead 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.
Kramer 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.
Fini 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.
Adey-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.
Norvang 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.
Kjeldsen 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.
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. doi: 10.1016/j.heliyon.2023.e21927. eCollection 2023 Nov.
Related Links
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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.
Other Identifiers
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H-22031667
Identifier Type: -
Identifier Source: org_study_id
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