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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
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    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
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    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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