- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04184843
Development and Evaluation of iWalk: A Guide to Facilitate Evidence-informed Assessment of Walking After Stroke
Stroke remains a major health concern and the second highest cause of disability worldwide. After experiencing a stroke, many people lose the ability to walk independently. As a result, people with stroke require intensive rehabilitation services, spend the majority of their time in physical therapy on retraining walking, and cite recovery of walking as a primary rehabilitation goal. Assessment of walking using reliable and valid tools is a recommended practice in stroke rehabilitation guidelines in Canada, the United States, Australia, and The Netherlands. The 10-metre walk test (10mWT) and the 6-minute walk test (6MWT) are highly recommended in guidelines and by professional organizations for the clinical evaluation of walking across the care continuum. For the 10mWT, the time to traverse the middle 10 metres of a 14-metre walkway at a comfortable pace is used to compute comfortable walking speed. For the 6MWT, the maximum distance achieved walking back and forth along a 30-metre walkway in six minutes is documented.
To facilitate physical therapists' (PTs') use of an evidence-informed approach to administering these walking tests post-stroke in an acute care, inpatient rehabilitation, or outpatient rehabilitation setting, the iWalk Toolkit, a theory-based toolkit, was developed. This Toolkit consists of an educational guide, a smartphone app, and an educational video.
In this mixed methods study, PTs across multiple sites were evaluated before and after a 5-month intervention involving the implementation of the iWalk Toolkit. Objectives of this study were: (1) to determine the nature and extent to which PTs across the care continuum uptake/use information in a theory-based toolkit designed to guide use of the 10-metre and 6-minute walk tests post-stroke for initial assessment, goal setting, education, treatment selection and monitoring change; and (2) to describe PTs' perceptions of the features of the guide, the provider and the setting that facilitated or prevented walk test administration and use of test scores for initial assessment, prognosis, goal setting, treatment selection and monitoring change.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Physical therapists working in hospitals providing acute care, in-patient rehabilitation, or outpatient rehabilitation services for people with stroke
- Physical therapists registered with the provincial regulatory body
- Physical therapists who provided walking rehabilitation to 10 or more patients with stroke per year
- Individuals in a professional leader (PL) or professional practice leader (PPL) role defined as an individual who was responsible for facilitating and advancing evidence-based physical therapy practice and ensuring that professional practice standards were met.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: iWalk Toolkit
Intervention period: 5 months Intervention:
|
Intervention period: 5 months Intervention:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the percentage of ambulatory patients post-stroke for which physical therapists have documented administration of walk tests in the health record at least once during the patient's hospital stay or physical therapy treatment
Time Frame: Change from baseline to 5 months
|
Data collected from patient health records pre- and post-intervention
|
Change from baseline to 5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the percentage of physical therapists in the action or maintenance stage determined using the 26-item self-report Clinician Readiness for Measuring Outcomes Scale.
Time Frame: Change from baseline to 5 months
|
Data collected from pre- and post-intervention online questionnaire.
|
Change from baseline to 5 months
|
|
Change in the mean self-efficacy rating on an 11-point ordinal scale ranging from 0% (no confidence) to 100% (completely confident) for physical therapists performing 12 unique walk test practices.
Time Frame: Change from baseline to 5 months
|
Data collected from pre- and post-intervention online questionnaire.
|
Change from baseline to 5 months
|
|
Median score from 1 (inadequate) to 5 (excellent) for each domain (engagement, functionality, aesthetics, and information quality) on the Mobile App Rating Scale (MARS).
Time Frame: At 5 months
|
Data collected from post-intervention online questionnaire.
|
At 5 months
|
|
Percentage of therapists who attended each learning session, reviewed each iWalk guide module and the video, practiced each walk test with colleagues, completed learning activities outlined in the guide, and used the app in clinical or various practices.
Time Frame: At 5 months
|
Participants indicated extent to which app was used in clinical practice (1, 2, 3, 4, or 5 months), and for various practices (none/little of the time, some of the time, or most/all of the time). Data collected from post-intervention online questionnaire. |
At 5 months
|
|
Physical therapists' perceptions of the features of the guide, the provider and the setting that facilitated or prevented walk test administration and use of test scores
Time Frame: Up to 8 months
|
Data collected from face-to-face or telephone interviews and focus groups held with participants post-intervention.
|
Up to 8 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nancy Salbach, PhD, University of Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAL322155
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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