External Validation of Two Prediction Models for Independent Gait After Stroke

Study Overview
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Brief Summary
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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.

Official Title
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External Validation of Two Prediction Models for Independent Gait After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: Standard stroke acute care and rehabilitation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | Other: Standard stroke acute care and rehabilitation<br>* According to Swiss national guidelines and local protocols<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait, Prognosis, External validation, EPOS model, TWIST model, Falls