- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05039047
External Validation of Two Prediction Models for Independent Gait After Stroke (REPEAT)
Regaining independent gait is one of the main goals in stroke rehabilitation and early prediction of gait outcome is important to guide discharge planning at acute stroke units, design rehabilitation and inform patients and relatives. In the last decade, two easy-to-apply prediction models for gait were developed: the EPOS model in the Netherlands and the TWIST model in New Zealand. Although the models' performance in the development cohorts was good, this does not automatically mean that the models are ready for application in clinical practice, as it is unknown whether their performance is also good in an independent cohort from a different country and with different patient characteristics. Such external validation is an essential step towards clinical implementation of prediction models.
A mobility-related problem is the occurrence of falls after stroke. Walking is among the Top 3 activities during which stroke patients fall, with the other two activities being transferring or sitting in a wheelchair. Especially soft tissue injuries after a fall are common and in 1-15% of the patients, the fall results in a fracture. Apart from the costs that arise from these injuries, falls have a negative impact on the patient's physical functioning and psychological status, with an increased dependency and fear of falling, resulting in a reduced quality of life.
A systematic review found 12 studies that developed fall risk prediction models for either inpatient rehabilitation stroke patients or those living in the community. Important predictors for falls are the presence of hemi-inattention, fall history and balance deficits. However, none of the models had an acceptable performance and predictors were not always captured by a validated assessment, which is an important prerequisite for an unbiased prediction model.
The primary aim of this study is to externally validate the EPOS and TWIST models for independent gait after stroke in a heterogeneous sample of subjects admitted to the hospital with an acute stroke. It is hypothesized that the performance of both models in this independent cohort will be lower than in the development cohorts, but still be adequate.
The secondary objective is to investigate the occurrence and predictability of falls within the first six months after stroke and its relationship with the prognosis for independent gait within this sample.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Janne M. Veerbeek, PhD
- Telefonní číslo: +41 41 205 13 17
- E-mail: janne.veerbeek@luks.ch
Studijní místa
-
-
-
Lucerne, Švýcarsko, 6000
- Nábor
- Luzerner Kantonsspital
-
Kontakt:
- Janne M. Veerbeek, PhD
- Telefonní číslo: +41 41 205 13 17
- E-mail: janne.veerbeek@luks.ch
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion criteria:
- First-ever or recurrent stroke as confirmed by computerized tomography and/ or magnetic resonance imaging
- Not able to walk independently within the first 72 hours after stroke (Functional Ambulation Categories <4)
- Age ≥18 year
- Written informed consent
Exclusion criterion:
• Not able to walk independently before hospital admission (Functional Ambulation Categories <4)
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
Kohorta
|
According to Swiss national guidelines and local protocols
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Functional Ambulation Categories (0-5 points, higher scores being better)
Časové okno: 6 weeks poststroke
|
Walking ability (independence)
|
6 weeks poststroke
|
Functional Ambulation Categories (0-5 points, higher scores being better)
Časové okno: 12 weeks poststroke
|
Walking ability (independence)
|
12 weeks poststroke
|
Functional Ambulation Categories (0-5 points, higher scores being better)
Časové okno: 26 weeks poststroke
|
Walking ability (independence)
|
26 weeks poststroke
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Falls
Časové okno: 6 weeks poststroke
|
Number of falls
|
6 weeks poststroke
|
Falls
Časové okno: 12 weeks poststroke
|
Number of falls
|
12 weeks poststroke
|
Falls
Časové okno: 26 weeks poststroke
|
Number of falls
|
26 weeks poststroke
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
National Institutes of Health Stroke Scale (0-42 points, lower scores being better)
Časové okno: Hospital admission, usually within 24 hours poststroke
|
Neurological functions
|
Hospital admission, usually within 24 hours poststroke
|
Trunk Control Test (0-100 points, higher scores being better)
Časové okno: within 72 hours poststroke
|
Trunk control
|
within 72 hours poststroke
|
Motricity Index - lower extremity subscale (0-100 points, higher scores being better)
Časové okno: within 72 hours poststroke
|
Lower extremity isometric muscle strength
|
within 72 hours poststroke
|
Medical Research Grading - hip extension (0-5 points, higher scores being better)
Časové okno: within 72 hours poststroke
|
Hip extension muscle strength
|
within 72 hours poststroke
|
Modified Rankin Scale (0-5 points, lower scores being better)
Časové okno: 6 weeks poststroke
|
Global disability
|
6 weeks poststroke
|
Modified Rankin Scale (0-5 points, lower scores being better)
Časové okno: 12 weeks poststroke
|
Global disability
|
12 weeks poststroke
|
Modified Rankin Scale (0-5 points, lower scores being better)
Časové okno: 26 weeks poststroke
|
Global disability
|
26 weeks poststroke
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Janne M. Veerbeek, PhD, Luzerner Kantonsspital
Publikace a užitečné odkazy
Obecné publikace
- Smith MC, Barber PA, Stinear CM. The TWIST Algorithm Predicts Time to Walking Independently After Stroke. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):955-964. doi: 10.1177/1545968317736820. Epub 2017 Nov 1.
- Batchelor FA, Mackintosh SF, Said CM, Hill KD. Falls after stroke. Int J Stroke. 2012 Aug;7(6):482-90. doi: 10.1111/j.1747-4949.2012.00796.x. Epub 2012 Apr 12.
- Steyerberg EW, Moons KG, van der Windt DA, Hayden JA, Perel P, Schroter S, Riley RD, Hemingway H, Altman DG; PROGRESS Group. Prognosis Research Strategy (PROGRESS) 3: prognostic model research. PLoS Med. 2013;10(2):e1001381. doi: 10.1371/journal.pmed.1001381. Epub 2013 Feb 5.
- Veerbeek JM, Van Wegen EE, Harmeling-Van der Wel BC, Kwakkel G; EPOS Investigators. Is accurate prediction of gait in nonambulatory stroke patients possible within 72 hours poststroke? The EPOS study. Neurorehabil Neural Repair. 2011 Mar-Apr;25(3):268-74. doi: 10.1177/1545968310384271. Epub 2010 Dec 26.
- Moons KGM, Wolff RF, Riley RD, Whiting PF, Westwood M, Collins GS, Reitsma JB, Kleijnen J, Mallett S. PROBAST: A Tool to Assess Risk of Bias and Applicability of Prediction Model Studies: Explanation and Elaboration. Ann Intern Med. 2019 Jan 1;170(1):W1-W33. doi: 10.7326/M18-1377.
- Moons KG, Kengne AP, Grobbee DE, Royston P, Vergouwe Y, Altman DG, Woodward M. Risk prediction models: II. External validation, model updating, and impact assessment. Heart. 2012 May;98(9):691-8. doi: 10.1136/heartjnl-2011-301247. Epub 2012 Mar 7.
- Lamb SE, Jorstad-Stein EC, Hauer K, Becker C; Prevention of Falls Network Europe and Outcomes Consensus Group. Development of a common outcome data set for fall injury prevention trials: the Prevention of Falls Network Europe consensus. J Am Geriatr Soc. 2005 Sep;53(9):1618-22. doi: 10.1111/j.1532-5415.2005.53455.x.
- Walsh M, Galvin R, Horgan NF. Fall-related experiences of stroke survivors: a meta-ethnography. Disabil Rehabil. 2017 Apr;39(7):631-640. doi: 10.3109/09638288.2016.1160445. Epub 2016 Mar 23.
- Walsh ME, Galvin R, Boland F, Williams D, Harbison JA, Murphy S, Collins R, Crowe M, McCabe DJH, Horgan F. Validation of two risk-prediction models for recurrent falls in the first year after stroke: a prospective cohort study. Age Ageing. 2017 Jul 1;46(4):642-648. doi: 10.1093/ageing/afw255.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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