Effects of an Educational Intervention on Rehabilitation Clinicians' Practices for Health-related Outcomes After Stroke

February 22, 2021 updated by: Aliki Thomas, McGill University

Effects of an Innovative Continuing Professional Development Intervention on Rehabilitation Clinicians' Practices to Improve Walking and Independence in Activities of Daily Living After Stroke: a Pilot Study

The overall aim of this pilot study is to evaluate the feasibility of a study protocol for a future stepped wedge cluster randomized clinical trial (c-RCT) that will investigate the effects of an innovative KT intervention on 1) walking capacity and independence in ADL in patients undergoing rehabilitation after stroke (patient outcomes); and 2) clinicians' practice (i.e. use of 4 evidence-based stroke rehabilitation interventions: motor imagery/mental practice, rhythmic auditory stimulation gait therapy, task oriented training including fitness and mobility exercises and aerobic training) (provider outcome) aimed at improving walking capacity. The specific objectives are: 1) To evaluate the feasibility (effectiveness of clinician recruitment strategies, extent of losses to follow-up across sites, and data analysis plans) of the study protocol in terms of methodology (stepped wedge design is an innovative methodology); 2) To estimate intervention effect sizes on study outcomes (patient and clinician); 3) To evaluate the secondary outcome (clinicians' use of the 4 interventions) with regard to reliability and validity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Walking capacity is the major priority for patients after stroke. Strong research evidence shows that walking capacity can be improved by rehabilitation interventions such as motor imagery, rhythmic auditory cueing, task-oriented training and aerobic exercise. Despite strong evidence for the effectiveness of these interventions on walking capacity, many clinicians (occupational therapists (OTs) and physical therapists (PTs)) do not use these in their practice. This knowledge translation (KT) pilot study aims to support evidence-based practice amongst rehabilitation clinicians working in stroke rehabilitation and collect data to inform a future larger clinical trial that will investigate if having repeated exposure to an innovative KT intervention will: increase clinicians' use of four targeted rehabilitation interventions (listed above) and positively affect walking capacity and independence in daily activities in patients after stroke. The investigators will recruit 2-3 OTs and 2-3 PTs per site from 6 major inpatient stroke rehabilitation centres across Canada to participate in a KT intervention consisting of an interactive and readily accessible web-based platform to deliver evidence-based knowledge on 4 rehabilitation interventions targeting walking capacity. This will be done via email in short online educational capsules including strategies for implementing the interventions and tools to promote reflection on current and future practice. They will then ask clinicians for feedback on: 1) the value of the knowledge delivered via email; 2) their perceptions about the success of using the guidelines with specific stroke patients; 3) the barriers they experienced when using the platform; and 4) the actual benefits for their patients. Through this innovative KT intervention, clinicians will have an opportunity to reflect upon and subsequently modify their practice to include evidence-based interventions known to improve walking capacity and functional independence.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Nanaimo, British Columbia, Canada, V9S 2B7
        • Nanaimo General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3L 2P4
        • Riverview Health Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Nova Scotia Health Authority
    • Ontario
      • North York, Ontario, Canada, M2M 2G1
        • St. John's Rehab - Sunnybrook Hospital
      • Toronto, Ontario, Canada, M4M 2B5
        • Bridgepoint Rehabilitation Hospital
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4S 0A5
        • Wascana Rehabilitation Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Occupational therapists and physical therapists with a minimum of 1 year clinical experience, working in an in-patient stroke rehabilitation centre in Canada.
  • Sites will be eligible if they do not have an existing format knowledge translation initiative directed at enhancing practice in mobility training, have at least 10 people with stroke on their unit on a regular basis, and have an interdisciplinary team consisting of 2-3 occupational therapists and 2-3 physical therapists.
  • Patients with a documented walking deficit (documented in patient's chart) and which are on the caseload of a minimum of one participating clinician.

Exclusion Criteria:

  • Occupational or physical therapists who are currently participating in another knowledge translation study directed at enhancing practice in mobility training.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Intervention
Arm: Intervention: Implementation of stroke mobility guidelines
Other: Implementation of stroke mobility guidelines
Delivery of weekly online educational capsules on 4 evidence-based stroke recommendations (motor imagery/mental practice, rhythmic auditory stimulation gait therapy, task-oriented training including fitness and mobility exercises, and aerobic training) plus feedback on participant's awareness, agreement, satisfaction with, and perceived value of the content, perceived implementation success and facilitators and barriers encountered.
NO_INTERVENTION: Control
Arm: Control: Usual care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Six minute walk test (walking ability)
Time Frame: 1-3 months
Measurement of the total distance walked over six minutes on a hard, flat surface
1-3 months
Functional Independence Measure
Time Frame: 1-3 months
7-level measurement of functional independence (1=total assist; 7=complete independence)
1-3 months
Functional Ambulation Category
Time Frame: 1-3 months
6-point measurement of functional ambulation (0=nonfunctional ambulation; 5=ambulator independent)
1-3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Information Assessment Method
Time Frame: 1-3 months
Clinician-reported feedback on weekly delivery and retrieval of health information provided in educational capsules
1-3 months
Clinician-reported feedback on caseload (Calculation of Indicators)
Time Frame: 1-3 months
Number of patients with stroke treated per week
1-3 months
Clinician-reported feedback on delivery of interventions (Calculation of Indicators)
Time Frame: 1-3 months
Duration of interventions delivered per stroke patient per week (in 5 minute increments)
1-3 months
Clinician-reported feedback on confidence level in ability to deliver interventions (Calculation of Indicators)
Time Frame: 1-3 months
Confidence level in ability to deliver interventions on 10-point scale (0=not at all confident; 10=extremely confident)
1-3 months
My Guidelines Implementation Barometer
Time Frame: 1-3 months
Clinician-reported feedback on application of guideline recommendations in clinical practice, barriers to implementation and expected health benefits. Clinicians will be asked to list the factors that influenced the use of those recommendations in their practice.
1-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Heart and Stroke Foundation of Canada - Canadian Partnership for Stroke Recovery
Réseau Provincial De Recherche En Adaptation-Réadaptation (REPAR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aliki Thomas, PhD, McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPSR-REPAR Research Award

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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