An observational study in Stroke, sponsored by Janne Veerbeek. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Janne Veerbeek · Observational
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.
7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 149 is close to the median of 160 across 1,729 observational studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Janne Veerbeek as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Admitted to a hospital with an acute stroke
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criterion:
Other: Standard stroke acute care and rehabilitation
According to Swiss national guidelines and local protocols
Functional Ambulation Categories (0-5 points, higher scores being better)
Walking ability (independence)
Time frame: 6 weeks poststroke
Functional Ambulation Categories (0-5 points, higher scores being better)
Walking ability (independence)
Time frame: 12 weeks poststroke
Functional Ambulation Categories (0-5 points, higher scores being better)
Walking ability (independence)
Time frame: 26 weeks poststroke
Falls
Number of falls
Time frame: 6 weeks poststroke
Falls
Number of falls
Time frame: 12 weeks poststroke
Falls
Number of falls
Time frame: 26 weeks poststroke
National Institutes of Health Stroke Scale (0-42 points, lower scores being better)
Neurological functions
Time frame: Hospital admission, usually within 24 hours poststroke
Trunk Control Test (0-100 points, higher scores being better)
Trunk control
Time frame: within 72 hours poststroke
Motricity Index - lower extremity subscale (0-100 points, higher scores being better)
Lower extremity isometric muscle strength
Time frame: within 72 hours poststroke
Medical Research Grading - hip extension (0-5 points, higher scores being better)
Hip extension muscle strength
Time frame: within 72 hours poststroke
Modified Rankin Scale (0-5 points, lower scores being better)
Global disability
Time frame: 6 weeks poststroke
Modified Rankin Scale (0-5 points, lower scores being better)
Global disability
Time frame: 12 weeks poststroke
Modified Rankin Scale (0-5 points, lower scores being better)
Global disability
Time frame: 26 weeks poststroke
Plan to share: Undecided
Ran from Oct 2021 to primary completion in Jun 2024, 31 months.
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This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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