- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03807115
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
Unknown
Intervention / Treatment
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
Interventional
Enrollment (Actual)
37
Phase
- 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
-
-
British Columbia
-
Nanaimo, British Columbia, Canada, V9S 2B7
- Nanaimo General Hospital
-
-
Manitoba
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Winnipeg, Manitoba, Canada, R3L 2P4
- Riverview Health Centre
-
-
Nova Scotia
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Halifax, Nova Scotia, Canada
- Nova Scotia Health Authority
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Ontario
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North York, Ontario, Canada, M2M 2G1
- St. John's Rehab - Sunnybrook Hospital
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Toronto, Ontario, Canada, M4M 2B5
- Bridgepoint Rehabilitation Hospital
-
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Saskatchewan
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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
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 |
Intervention / Treatment |
|---|---|
|
OTHER: Intervention
Arm: Intervention: 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
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
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
Collaborators
Investigators
- 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
- Mayo NE, Wood-Dauphinee S, Cote R, Durcan L, Carlton J. Activity, participation, and quality of life 6 months poststroke. Arch Phys Med Rehabil. 2002 Aug;83(8):1035-42. doi: 10.1053/apmr.2002.33984.
- Korner-Bitensky N, Desrosiers J, Rochette A. A national survey of occupational therapists' practices related to participation post-stroke. J Rehabil Med. 2008 Apr;40(4):291-7. doi: 10.2340/16501977-0167.
- Salbach NM, Veinot P, Rappolt S, Bayley M, Burnett D, Judd M, Jaglal SB. Physical therapists' experiences updating the clinical management of walking rehabilitation after stroke: a qualitative study. Phys Ther. 2009 Jun;89(6):556-68. doi: 10.2522/ptj.20080249. Epub 2009 Apr 16.
- Salbach NM, Veinot P, Jaglal SB, Bayley M, Rolfe D. From continuing education to personal digital assistants: what do physical therapists need to support evidence-based practice in stroke management? J Eval Clin Pract. 2011 Aug;17(4):786-93. doi: 10.1111/j.1365-2753.2010.01456.x. Epub 2010 Oct 12.
- Rochette A, Korner-Bitensky N, Desrosiers J. Actual vs best practice for families post-stroke according to three rehabilitation disciplines. J Rehabil Med. 2007 Sep;39(7):513-9. doi: 10.2340/16501977-0082.
- Cahill LS, Carey LM, Lannin NA, Turville M, Neilson CL, Lynch EA, McKinstry CE, Han JX, O'Connor D. Implementation interventions to promote the uptake of evidence-based practices in stroke rehabilitation. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD012575. doi: 10.1002/14651858.CD012575.pub2.
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)
February 24, 2020
Primary Completion (ANTICIPATED)
October 15, 2021
Study Completion (ANTICIPATED)
December 31, 2021
Study Registration Dates
First Submitted
December 21, 2018
First Submitted That Met QC Criteria
January 14, 2019
First Posted (ACTUAL)
January 16, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 23, 2021
Last Update Submitted That Met QC Criteria
February 22, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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