Development and Evaluation of iWalk: A Guide to Facilitate Evidence-informed Assessment of Walking After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iWalk Toolkit
Sponsored by

About this trial
This is an interventional diagnostic trial for Stroke
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iWalk Toolkit
Arm Description
Intervention period: 5 months Intervention: A toolkit consisting of 3 components: an educational guide, a smartphone app, and an educational video. Access to a clinical expert by email or phone
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Data collected from pre- and post-intervention online questionnaire.
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.
Data collected from pre- and post-intervention online questionnaire.
Median score from 1 (inadequate) to 5 (excellent) for each domain (engagement, functionality, aesthetics, and information quality) on the Mobile App Rating Scale (MARS).
Data collected from post-intervention online questionnaire.
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.
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.
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
Data collected from face-to-face or telephone interviews and focus groups held with participants post-intervention.
Full Information
NCT ID
NCT04184843
First Posted
November 8, 2019
Last Updated
November 29, 2019
Sponsor
University of Toronto
Collaborators
Dalhousie University, University Health Network, Toronto, Nova Scotia Health Authority, McMaster University, CorHealth Ontario, Drexel University, Sunnybrook Health Sciences Centre, Sinai Health System, Unity Health Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04184843
Brief Title
Development and Evaluation of iWalk: A Guide to Facilitate Evidence-informed Assessment of Walking After Stroke
Official Title
Development and Evaluation of iWalk: A Guide to Facilitate Evidence-informed Assessment of Walking After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
Dalhousie University, University Health Network, Toronto, Nova Scotia Health Authority, McMaster University, CorHealth Ontario, Drexel University, Sunnybrook Health Sciences Centre, Sinai Health System, Unity Health Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iWalk Toolkit
Arm Type
Experimental
Arm Description
Intervention period: 5 months
Intervention:
A toolkit consisting of 3 components: an educational guide, a smartphone app, and an educational video.
Access to a clinical expert by email or phone
Intervention Type
Other
Intervention Name(s)
iWalk Toolkit
Intervention Description
Intervention period: 5 months
Intervention:
A toolkit consisting of 3 components: an educational guide, a smartphone app, and an educational video.
Access to a clinical expert by email or phone
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.
Description
Data collected from pre- and post-intervention online questionnaire.
Time Frame
Change from baseline to 5 months
Title
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.
Description
Data collected from pre- and post-intervention online questionnaire.
Time Frame
Change from baseline to 5 months
Title
Median score from 1 (inadequate) to 5 (excellent) for each domain (engagement, functionality, aesthetics, and information quality) on the Mobile App Rating Scale (MARS).
Description
Data collected from post-intervention online questionnaire.
Time Frame
At 5 months
Title
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.
Description
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.
Time Frame
At 5 months
Title
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
Description
Data collected from face-to-face or telephone interviews and focus groups held with participants post-intervention.
Time Frame
Up to 8 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Salbach, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Development and Evaluation of iWalk: A Guide to Facilitate Evidence-informed Assessment of Walking After Stroke
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