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External Validation of Two Prediction Models for Independent Gait After Stroke

External Validation of Two Prediction Models for Independent Gait After Stroke

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05039047
Acronym
REPEAT
Enrollment
149
Registered
2021-09-09
Start date
2021-10-19
Completion date
2024-06-07
Last updated
2024-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Gait, Prognosis, External validation, EPOS model, TWIST model, Falls

Brief 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. 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.

Interventions

OTHERStandard stroke acute care and rehabilitation

According to Swiss national guidelines and local protocols

Sponsors

Janne Veerbeek
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Functional Ambulation Categories (0-5 points, higher scores being better)6 weeks poststrokeWalking ability (independence)

Secondary

MeasureTime frameDescription
Falls6 weeks poststrokeNumber of falls

Other

MeasureTime frameDescription
Motricity Index - lower extremity subscale (0-100 points, higher scores being better)within 72 hours poststrokeLower extremity isometric muscle strength
National Institutes of Health Stroke Scale (0-42 points, lower scores being better)Hospital admission, usually within 24 hours poststrokeNeurological functions
Modified Rankin Scale (0-5 points, lower scores being better)6 weeks poststrokeGlobal disability
Medical Research Grading - hip extension (0-5 points, higher scores being better)within 72 hours poststrokeHip extension muscle strength
Trunk Control Test (0-100 points, higher scores being better)within 72 hours poststrokeTrunk control

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026