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Completed

NCT Number: 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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iWalk Toolkit

Other

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 outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • CorHealth Ontario
  • Dalhousie University
  • Drexel University
  • McMaster University
  • Nova Scotia Health Authority
  • Sinai Health System
  • Sunnybrook Health Sciences Centre
  • Unity Health Toronto
  • University Health Network, Toronto

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 4, 2019
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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