StrokeNCT06438770
Prediction of Gait After Stroke; an External Validation
An observational study of Stroke, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
Trial summary
The aim of this observational study is to perform a temporal and geographical external validation of the EPOS (Early Prediction of Outcome after Stroke) model for the prediction of independent gait after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 136 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2020to 15 Sep 2023
- 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: admitted to hospital with an acute stroke
Who may be able to join
- aged 18 years or older
- having suffered an ischemic or hemorrhagic stroke, confirmed by computerized tomography and/ or magnetic resonance imaging
- being unable to walk independently (FAC < 4) within 72 hours
- giving written informed consent to participate
Who cannot join
- not able to walk independently before hospital admission (FAC < 4)
- clinically significant comorbidities that prevent walking ability
- deficits in cognition or communication, so consent cannot be given for study participation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
About this study
Official title: Predicting Independent Gait After Stroke: External Validation of a Multivariable Prediction Model
The aim of this observational study is to perform a temporal and geographical external validation of the EPOS (Early Prediction of Outcome after Stroke) model for the prediction of independent gait after stroke. The EPOS model measures the early presence of leg strength on the affected side and sitting ability to predict recovery of independent walking six months after stroke. Compared to the EPOS model development study, the prediction time point of independent gait in this study will be three months rather than six months post-stroke and the patients will be more heterogeneous. Due to the differences in the new cohort, it is expected that the performance of the models will be lower than in the development cohort, but still be adequate.
Read the detailed description
Worldwide, stroke is the second leading cause of death and is also the third leading cause of death and disability combined. According to the Global Burden of Disease, Injuries, and Risk Factors Study (GBD) by the Collaborator Network on the topic of stroke, the absolute number of incidence strokes and their deaths have steadily increased in recent years. The most important risk factors include high blood pressure, a high body-mass index, high plasma glucose, fine dust pollution and smoking. In Switzerland, an average of 20'423 people suffered a stroke per year between 2016 and 2020. Due to the growth and ageing of the population, the number of hospitalizations due to cardiovascular diseases is increasing, but deaths have decreased over time. According to a recent study, 75% of stroke survivors are able to walk independently after three months. On average, independent walking is achieved six days post-stroke whereby stroke severity is most strongly associated with recovery of gait.
In recent years, a large number of studies have been published showing that prognosis is of growing interest in stroke rehabilitation. Medical prognostic models are used to inform patients and their families about the course of their disease and to plan possible treatments. Early prognosis of recovery after stroke enables early discharge planning and efficient use of health care resources. In addition, therapy goals can be realistically formulated and thus recommendations for care or adaptations of the home environment can be made. Currently, prognostic models are rarely used in clinical practice. This is partly because most of the models have not been externally validated, which is a prerequisite for implementation in practice. External validation involves using new data from a similar population to investigate the generalizability of the model. In summary, a good and useful prognostic model should be accurate, generalizable and ideally clinically effective.
A narrative review described six prognostic models for independent gait after stroke. Only three of these models measure predictor and outcome variables at a specifically defined time point: the Australian model, the TWIST model and the EPOS model. The Australian model and the TWIST model have been updated but not externally validated and the EPOS model has been externally validated once. According to the review above, the EPOS model seems to be a promising model for predicting independent gait after a stroke. This is due to the early and fixed time point of simple and fast clinical tests as well as the prognosis time point of six months. The EPOS model shows that early presence of lower limb strength and sitting ability can predict recovery of independent walking six months after stroke. Predictive variables were measured using the Trunk Control Test with the item "sitting balance" (TCT-s) and the Motricity Index leg score (MI leg). The dependent outcome variable was the Functional Ambulation Categories (FAC). In the external validation, the dependent outcome variable FAC was measured after three months. The results show good performance of the model from the third day onwards for predicting independent gait three months after stroke.
In summary, these findings raise the question of whether the use of the EPOS model in post-stroke patients within the first 72 hours is accurate and generalizable for predicting independent walking three months after stroke. Although this first external validation shows promising results, further external validation studies need to be undertaken before the model can be applied in clinical practice. The aim of this study is to perform a temporal and geographical external validation of the EPOS prediction model for independent gait after stroke. Compared to the development study, this study will be conducted in Switzerland and the prediction of independent gait will be based on the time point of three months rather than six months post-stroke. In addition, all post-stroke patients will be included, regardless of the type of stroke, the affected circulation or positive stroke history. Furthermore, patients with pre-existing comorbidities are also being considered, as long as they were ambulatory before the stroke.
- Conditions
- Stroke
- Keywords
- prediction model, external validation
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Ambulation Categories (0-5 points, higher scores being better)
functional gait
Measured: 3 months poststroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Jul 2020
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Betschart, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438770
- Sponsor's protocol ID
- 2020-01966
- Status last verified
- May 2025
- First submitted
- 27 May 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
PubMed 34487721Kennedy C, Bernhardt J, Churilov L, Collier JM, Ellery F, Rethnam V, Carvalho LB, Donnan GA, Hayward KS. Factors associated with time to independent walking recovery post-stroke. J Neurol Neurosurg Psychiatry. 2021 Jul;92(7):702-708. doi: 10.1136/jnnp-2020-325125. Epub 2021 Mar 17.
PubMed 33737383Ramspek CL, Jager KJ, Dekker FW, Zoccali C, van Diepen M. External validation of prognostic models: what, why, how, when and where? Clin Kidney J. 2020 Nov 24;14(1):49-58. doi: 10.1093/ckj/sfaa188. eCollection 2021 Jan.
PubMed 33564405Moons KG, Royston P, Vergouwe Y, Grobbee DE, Altman DG. Prognosis and prognostic research: what, why, and how? BMJ. 2009 Feb 23;338:b375. doi: 10.1136/bmj.b375. No abstract available.
PubMed 19237405Kwah LK, Herbert RD. Prediction of Walking and Arm Recovery after Stroke: A Critical Review. Brain Sci. 2016 Nov 2;6(4):53. doi: 10.3390/brainsci6040053.
PubMed 27827835Altman DG, Vergouwe Y, Royston P, Moons KG. Prognosis and prognostic research: validating a prognostic model. BMJ. 2009 May 28;338:b605. doi: 10.1136/bmj.b605. No abstract available.
PubMed 19477892Langerak AJ, McCambridge AB, Stubbs PW, Fabricius J, Rogers K, Quel de Oliveira C, Nielsen JF, Verhagen AP. Externally validated model predicting gait independence after stroke showed fair performance and improved after updating. J Clin Epidemiol. 2021 Sep;137:73-82. doi: 10.1016/j.jclinepi.2021.03.022. Epub 2021 Mar 31.
PubMed 33812010Kwah LK, Harvey LA, Diong J, Herbert RD. Models containing age and NIHSS predict recovery of ambulation and upper limb function six months after stroke: an observational study. J Physiother. 2013 Sep;59(3):189-97. doi: 10.1016/S1836-9553(13)70183-8.
PubMed 23896334Veerbeek 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.
PubMed 21186329Stinear CM, Smith MC, Byblow WD. Prediction Tools for Stroke Rehabilitation. Stroke. 2019 Nov;50(11):3314-3322. doi: 10.1161/STROKEAHA.119.025696. Epub 2019 Oct 15. No abstract available.
PubMed 31610763Smith MC, Barber AP, Scrivener BJ, Stinear CM. The TWIST Tool Predicts When Patients Will Recover Independent Walking After Stroke: An Observational Study. Neurorehabil Neural Repair. 2022 Jul;36(7):461-471. doi: 10.1177/15459683221085287. Epub 2022 May 18.
PubMed 35586876Veerbeek JM, Pohl J, Held JPO, Luft AR. External Validation of the Early Prediction of Functional Outcome After Stroke Prediction Model for Independent Gait at 3 Months After Stroke. Front Neurol. 2022 May 2;13:797791. doi: 10.3389/fneur.2022.797791. eCollection 2022.
PubMed 35585839Smith 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.
PubMed 29090654Vinzens L, Betschart M, Veerbeek JM. External Validation of the EPOS Prediction Model for Independent Gait After Stroke. Neurorehabil Neural Repair. 2026 May 15:15459683261425934. doi: 10.1177/15459683261425934. Online ahead of print.
PubMed 42136245
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Independent Gait After Stroke: External Validation of a Multivariable Prediction Model
- ClinicalTrials.gov ID
- NCT06438770
- Acronym / sponsor ID
- 2020-01966
- Conditions
- Stroke
- Keywords
- prediction model, external validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 3 Jun 2024 (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 aim of this observational study is to perform a temporal and geographical external validation of the EPOS (Early Prediction of Outcome after Stroke) model for the prediction of independent gait after stroke. The EPOS model measures the early presence of leg strength on the affected side and sitting ability to predict recovery of independent walking six months after stroke. Compared to the EPOS model development study, the prediction time point of independent gait in this study will be three months rather than six months post-stroke and the patients will be more heterogeneous. Due to the differences in the new cohort, it is expected that the performance of the models will be lower than in the development cohort, but still be adequate.
Detailed description
Worldwide, stroke is the second leading cause of death and is also the third leading cause of death and disability combined. According to the Global Burden of Disease, Injuries, and Risk Factors Study (GBD) by the Collaborator Network on the topic of stroke, the absolute number of incidence strokes and their deaths have steadily increased in recent years. The most important risk factors include high blood pressure, a high body-mass index, high plasma glucose, fine dust pollution and smoking. In Switzerland, an average of 20'423 people suffered a stroke per year between 2016 and 2020. Due to the growth and ageing of the population, the number of hospitalizations due to cardiovascular diseases is increasing, but deaths have decreased over time. According to a recent study, 75% of stroke survivors are able to walk independently after three months. On average, independent walking is achieved six days post-stroke whereby stroke severity is most strongly associated with recovery of gait.
In recent years, a large number of studies have been published showing that prognosis is of growing interest in stroke rehabilitation. Medical prognostic models are used to inform patients and their families about the course of their disease and to plan possible treatments. Early prognosis of recovery after stroke enables early discharge planning and efficient use of health care resources. In addition, therapy goals can be realistically formulated and thus recommendations for care or adaptations of the home environment can be made. Currently, prognostic models are rarely used in clinical practice. This is partly because most of the models have not been externally validated, which is a prerequisite for implementation in practice. External validation involves using new data from a similar population to investigate the generalizability of the model. In summary, a good and useful prognostic model should be accurate, generalizable and ideally clinically effective.
A narrative review described six prognostic models for independent gait after stroke. Only three of these models measure predictor and outcome variables at a specifically defined time point: the Australian model, the TWIST model and the EPOS model. The Australian model and the TWIST model have been updated but not externally validated and the EPOS model has been externally validated once. According to the review above, the EPOS model seems to be a promising model for predicting independent gait after a stroke. This is due to the early and fixed time point of simple and fast clinical tests as well as the prognosis time point of six months. The EPOS model shows that early presence of lower limb strength and sitting ability can predict recovery of independent walking six months after stroke. Predictive variables were measured using the Trunk Control Test with the item "sitting balance" (TCT-s) and the Motricity Index leg score (MI leg). The dependent outcome variable was the Functional Ambulation Categories (FAC). In the external validation, the dependent outcome variable FAC was measured after three months. The results show good performance of the model from the third day onwards for predicting independent gait three months after stroke.
In summary, these findings raise the question of whether the use of the EPOS model in post-stroke patients within the first 72 hours is accurate and generalizable for predicting independent walking three months after stroke. Although this first external validation shows promising results, further external validation studies need to be undertaken before the model can be applied in clinical practice. The aim of this study is to perform a temporal and geographical external validation of the EPOS prediction model for independent gait after stroke. Compared to the development study, this study will be conducted in Switzerland and the prediction of independent gait will be based on the time point of three months rather than six months post-stroke. In addition, all post-stroke patients will be included, regardless of the type of stroke, the affected circulation or positive stroke history. Furthermore, patients with pre-existing comorbidities are also being considered, as long as they were ambulatory before the stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- admitted to hospital with an acute stroke
Key inclusion criteria (4 listed)
- aged 18 years or older
- having suffered an ischemic or hemorrhagic stroke, confirmed by computerized tomography and/ or magnetic resonance imaging
- being unable to walk independently (FAC < 4) within 72 hours
- giving written informed consent to participate
Key exclusion criteria (3 listed)
- not able to walk independently before hospital admission (FAC < 4)
- clinically significant comorbidities that prevent walking ability
- deficits in cognition or communication, so consent cannot be given for study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Ambulation Categories (0-5 points, higher scores being better)
Time frame: 3 months poststroke
functional gait
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Background: PubMed 34487721GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
- Background: PubMed 33737383Kennedy C, Bernhardt J, Churilov L, Collier JM, Ellery F, Rethnam V, Carvalho LB, Donnan GA, Hayward KS. Factors associated with time to independent walking recovery post-stroke. J Neurol Neurosurg Psychiatry. 2021 Jul;92(7):702-708. doi: 10.1136/jnnp-2020-325125. Epub 2021 Mar 17.
- Background: PubMed 33564405Ramspek CL, Jager KJ, Dekker FW, Zoccali C, van Diepen M. External validation of prognostic models: what, why, how, when and where? Clin Kidney J. 2020 Nov 24;14(1):49-58. doi: 10.1093/ckj/sfaa188. eCollection 2021 Jan.
- Background: PubMed 19237405Moons KG, Royston P, Vergouwe Y, Grobbee DE, Altman DG. Prognosis and prognostic research: what, why, and how? BMJ. 2009 Feb 23;338:b375. doi: 10.1136/bmj.b375. No abstract available.
- Background: PubMed 27827835Kwah LK, Herbert RD. Prediction of Walking and Arm Recovery after Stroke: A Critical Review. Brain Sci. 2016 Nov 2;6(4):53. doi: 10.3390/brainsci6040053.
- Background: PubMed 19477892Altman DG, Vergouwe Y, Royston P, Moons KG. Prognosis and prognostic research: validating a prognostic model. BMJ. 2009 May 28;338:b605. doi: 10.1136/bmj.b605. No abstract available.
- Background: PubMed 33812010Langerak AJ, McCambridge AB, Stubbs PW, Fabricius J, Rogers K, Quel de Oliveira C, Nielsen JF, Verhagen AP. Externally validated model predicting gait independence after stroke showed fair performance and improved after updating. J Clin Epidemiol. 2021 Sep;137:73-82. doi: 10.1016/j.jclinepi.2021.03.022. Epub 2021 Mar 31.
- Background: PubMed 23896334Kwah LK, Harvey LA, Diong J, Herbert RD. Models containing age and NIHSS predict recovery of ambulation and upper limb function six months after stroke: an observational study. J Physiother. 2013 Sep;59(3):189-97. doi: 10.1016/S1836-9553(13)70183-8.
- Background: PubMed 21186329Veerbeek 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.
- Background: PubMed 31610763Stinear CM, Smith MC, Byblow WD. Prediction Tools for Stroke Rehabilitation. Stroke. 2019 Nov;50(11):3314-3322. doi: 10.1161/STROKEAHA.119.025696. Epub 2019 Oct 15. No abstract available.
- Background: PubMed 35586876Smith MC, Barber AP, Scrivener BJ, Stinear CM. The TWIST Tool Predicts When Patients Will Recover Independent Walking After Stroke: An Observational Study. Neurorehabil Neural Repair. 2022 Jul;36(7):461-471. doi: 10.1177/15459683221085287. Epub 2022 May 18.
- Background: PubMed 35585839Veerbeek JM, Pohl J, Held JPO, Luft AR. External Validation of the Early Prediction of Functional Outcome After Stroke Prediction Model for Independent Gait at 3 Months After Stroke. Front Neurol. 2022 May 2;13:797791. doi: 10.3389/fneur.2022.797791. eCollection 2022.
- Schweizerisches GesundheitsobservatoriumLink provided by the sponsor.
- Bundesamt für StatistikLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stroke, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
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 4 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: finished, as of the sponsor's last update on 22 May 2025. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Ambulation Categories (0-5 points, higher scores being better) (time frame: 3 months poststroke). 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 NCT06438770, which also lists 14 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 22 May 2025.