Prediction of Gait After Stroke; an External Validation

NCT06438770 | Completed

• 1 other identifier: 2020-01966
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Keywords

prediction model; external validation

Outcome Measures

Primary Outcomes (1)

• Functional Ambulation Categories (0-5 points, higher scores being better)

  functional gait

  3 months poststroke

Other Outcomes (2)

• Trunk Control Test (0-100 points, higher scores being better)

  within 72 hours poststroke

• Motricity Index - lower extremity subscale (0-100 points, higher scores being better)

  within 72 hours poststroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

admitted to hospital with an acute stroke

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead

Study Sites (1)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

Location

Related Publications (13)

• 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.

  PMID: 34487721 BACKGROUND

• Kennedy 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.

  PMID: 33737383 BACKGROUND

• Ramspek 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.

  PMID: 33564405 BACKGROUND

• Moons 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.

  PMID: 19237405 BACKGROUND

• Kwah 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.

  PMID: 27827835 BACKGROUND

• Altman 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.

  PMID: 19477892 BACKGROUND

• Langerak 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.

  PMID: 33812010 BACKGROUND

• Kwah 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.

  PMID: 23896334 BACKGROUND

• 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.

  PMID: 21186329 BACKGROUND

• Stinear 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.

  PMID: 31610763 BACKGROUND

• Smith 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.

  PMID: 35586876 BACKGROUND

• Veerbeek 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.

  PMID: 35585839 BACKGROUND

• 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.

  PMID: 29090654 BACKGROUND

Related Links

• Schweizerisches Gesundheitsobservatorium
• Bundesamt für Statistik

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Physiotherapist, Clinical Specialist

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 3, 2024
• Study Start: July 1, 2020
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

CH (1)