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StrokeREPEATNCT05039047

External Validation of Two Prediction Models for Independent Gait After Stroke

An observational study of Stroke, run by Janne Veerbeek at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Standard stroke acute care and rehabilitation
How many people
149 participants
Where
1 siteSwitzerland
Study dates
19 Oct 2021to 7 Jun 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: Admitted to a hospital with an acute stroke

Who may be able to join

  • 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

Who cannot join

  • Not able to walk independently before hospital admission (Functional Ambulation Categories <4)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Luzerner Kantonsspital

    Lucerne, 6000

Other trials in Switzerland

About this study

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.

Read more

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.

Conditions
Stroke
Being tested
Standard stroke acute care and rehabilitation
Keywords
Gait, Prognosis, External validation, EPOS model, TWIST model, Falls
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard stroke acute care and rehabilitationOther

    According to Swiss national guidelines and local protocols

Study groups in NCT05039047
Study groupRoleWhat they receive
CohortNot described
Receives: Other: Standard stroke acute care and rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Walking ability (independence)

    Measured: 6 weeks poststroke

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

    Walking ability (independence)

    Measured: 12 weeks poststroke

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

    Walking ability (independence)

    Measured: 26 weeks poststroke

Secondary outcomes (3)

  1. Falls

    Number of falls

    Measured: 6 weeks poststroke

  2. Falls

    Number of falls

    Measured: 12 weeks poststroke

  3. Falls

    Number of falls

    Measured: 26 weeks poststroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2021
  2. Study start19 Oct 2021
  3. Primary completion7 Jun 2024
  4. Study completion7 Jun 2024

Why it stopped: Change position of PI, no replacement available, therefore unable to continue recruitment - all enrolled patients finished the study according to plan

Resources

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
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05039047
Sponsor's protocol ID
BASEC-ID 2021-01519
Acronym
REPEAT
Status last verified
Oct 2024
First submitted
18 Aug 2021
Last updated
17 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 21186329

  • 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.

    PubMed 29090654

  • 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.

    PubMed 23393430

  • 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.

    PubMed 30596876

  • 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.

    PubMed 22397946

  • 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.

    PubMed 16137297

  • 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.

    PubMed 22494388

  • 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.

    PubMed 27008035

  • 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.

    PubMed 28104593

  • Rajkovic LA, Veerbeek-Preuss S, Bartschi S, Ottiger B, Nyffeler T, Veerbeek JM. External Validation of the Time to Walking Independently After Stroke (TWIST) Prediction Algorithm within 72 Hours Poststroke. Neurorehabil Neural Repair. 2026 Aug 26:15459683261477077. doi: 10.1177/15459683261477077. Online ahead of print.

    PubMed 42648903

  • Vinzens 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

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Janne Veerbeek 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 1 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: stopped early, as of the sponsor's last update on 17 Oct 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 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 was stopped early (reason given: Change position of PI, no replacement available, therefore unable to continue recruitment - all enrolled patients finished the study according to plan). 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?

Functional Ambulation Categories (0-5 points, higher scores being better) (time frame: 6 weeks poststroke). The study lists 3 primary outcomes in all. 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 NCT05039047, which also lists 11 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 17 Oct 2024.

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