NCT04184843

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Sep 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

1.8 years

First QC Date

November 8, 2019

Last Update Submit

December 8, 2023

Conditions

Outcome Measures

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

    Data collected from patient health records pre- and post-intervention

    Change from baseline to 5 months

Secondary Outcomes (5)

  • 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.

    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.

    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).

    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.

    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

    Up to 8 months

Study Arms (1)

iWalk Toolkit

EXPERIMENTAL

Intervention period: 5 months Intervention: 1. A toolkit consisting of 3 components: an educational guide, a smartphone app, and an educational video. 2. Access to a clinical expert by email or phone

Other: iWalk Toolkit

Interventions

Intervention period: 5 months Intervention: 1. A toolkit consisting of 3 components: an educational guide, a smartphone app, and an educational video. 2. Access to a clinical expert by email or phone

iWalk Toolkit

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Salbach NM, MacKay-Lyons M, Howe JA, McDonald A, Solomon P, Bayley MT, McEwen S, Nelson M, Bulmer B, Lovasi GS. Assessment of Walking Speed and Distance Post-Stroke Increases After Providing a Theory-Based Toolkit. J Neurol Phys Ther. 2022 Oct 1;46(4):251-259. doi: 10.1097/NPT.0000000000000406. Epub 2022 Jun 7.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nancy Salbach, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 8, 2019

First Posted

December 4, 2019

Study Start

September 1, 2015

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

December 15, 2023

Record last verified: 2023-12