External Validation of Two Prediction Models for Independent Gait After Stroke (REPEAT)

October 15, 2024 updated by: Janne Veerbeek

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lucerne, Switzerland, 6000
        • Luzerner Kantonsspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Admitted to a hospital with an acute stroke

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
Other: Standard stroke acute care and rehabilitation
According to Swiss national guidelines and local protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Ambulation Categories (0-5 points, higher scores being better)
Time Frame: 6 weeks poststroke
Walking ability (independence)
6 weeks poststroke
Functional Ambulation Categories (0-5 points, higher scores being better)
Time Frame: 12 weeks poststroke
Walking ability (independence)
12 weeks poststroke
Functional Ambulation Categories (0-5 points, higher scores being better)
Time Frame: 26 weeks poststroke
Walking ability (independence)
26 weeks poststroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Falls
Time Frame: 6 weeks poststroke
Number of falls
6 weeks poststroke
Falls
Time Frame: 12 weeks poststroke
Number of falls
12 weeks poststroke
Falls
Time Frame: 26 weeks poststroke
Number of falls
26 weeks poststroke

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institutes of Health Stroke Scale (0-42 points, lower scores being better)
Time Frame: 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)
Time Frame: within 72 hours poststroke
Trunk control
within 72 hours poststroke
Motricity Index - lower extremity subscale (0-100 points, higher scores being better)
Time Frame: 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)
Time Frame: within 72 hours poststroke
Hip extension muscle strength
within 72 hours poststroke
Modified Rankin Scale (0-5 points, lower scores being better)
Time Frame: 6 weeks poststroke
Global disability
6 weeks poststroke
Modified Rankin Scale (0-5 points, lower scores being better)
Time Frame: 12 weeks poststroke
Global disability
12 weeks poststroke
Modified Rankin Scale (0-5 points, lower scores being better)
Time Frame: 26 weeks poststroke
Global disability
26 weeks poststroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janne Veerbeek

Investigators

  • Principal Investigator: Janne M. Veerbeek, PhD, Luzerner Kantonsspital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2021

Primary Completion (Actual)

June 7, 2024

Study Completion (Actual)

June 7, 2024

Study Registration Dates

First Submitted

August 18, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 9, 2021

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC-ID 2021-01519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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