StrokeNCT03807115
Effects of an Educational Intervention on Rehabilitation Clinicians' Practices for Health-related Outcomes After Stroke
A study testing Implementation of stroke mobility guidelines in people with Stroke and Knowledge, Attitudes, Practice, run by McGill University at 6 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stroke, Knowledge, Attitudes, Practice, Physical Disability
- What is being tested?
- Implementation of stroke mobility guidelines
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 6 sitesCanada
- Study dates
- 24 Feb 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Occupational or physical therapists who are currently participating in another knowledge translation study directed at enhancing practice in mobility training.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Nova Scotia Health Authority
Halifax, Nova Scotia
Nanaimo General Hospital
Nanaimo, British Columbia, V9S 2B7
St. John's Rehab - Sunnybrook Hospital
North York, Ontario, M2M 2G1
Wascana Rehabilitation Centre
Regina, Saskatchewan, S4S 0A5
Bridgepoint Rehabilitation Hospital
Toronto, Ontario, M4M 2B5
Riverview Health Centre
Winnipeg, Manitoba, R3L 2P4
About this study
Official title: 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.
Read the 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.
- Being tested
- Implementation of stroke mobility guidelines
- Keywords
- Stroke, Rehabilitation, Knowledge translation intervention, Walking capacity
- Medical subject headings
- Stroke, Behavior, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of stroke mobility guidelinesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Arm: Intervention: Implementation of stroke mobility guidelines Receives: Other: Implementation of stroke mobility guidelines |
| Control | No intervention | Arm: Control: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walk test (walking ability)
Measurement of the total distance walked over six minutes on a hard, flat surface
Measured: 1-3 months
Functional Independence Measure
7-level measurement of functional independence (1=total assist; 7=complete independence)
Measured: 1-3 months
Functional Ambulation Category
6-point measurement of functional ambulation (0=nonfunctional ambulation; 5=ambulator independent)
Measured: 1-3 months
Secondary outcomes (5)
Information Assessment Method
Clinician-reported feedback on weekly delivery and retrieval of health information provided in educational capsules
Measured: 1-3 months
Clinician-reported feedback on caseload (Calculation of Indicators)
Number of patients with stroke treated per week
Measured: 1-3 months
Clinician-reported feedback on delivery of interventions (Calculation of Indicators)
Duration of interventions delivered per stroke patient per week (in 5 minute increments)
Measured: 1-3 months
Clinician-reported feedback on confidence level in ability to deliver interventions (Calculation of Indicators)
Confidence level in ability to deliver interventions on 10-point scale (0=not at all confident; 10=extremely confident)
Measured: 1-3 months
My Guidelines Implementation Barometer
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.
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start24 Feb 2020
- Primary completion15 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a pilot stepped-wedge c-RCT. Data collection will take place over 16 weeks at 6 sites. Patient chart data (Functional Independence Measure (FIM), Functional Ambulation Category (FAC), 6-Minute-Walk-Test) will be collected weekly at all sites. Weeks 1-12: Participants at sites 1-6 will submit a weekly Calculation of Indicators (COI). Weeks 1-12: Sites 1 and 2 will receive 4 weekly online intervention packages and submit Information Assessment Method (IAM) and COI questionnaires for 12 weeks. Weeks 5-12: Sites 3 and 4 will receive 4 weekly online intervention packages and submit IAM and COI questionnaires for 8 weeks. Weeks 9-12: Sites 5 and 6 will receive 4 weekly online intervention packages and submit IAM and COI questionnaires for a total of 4 weeks. The longest exposure to the intervention will be 3 months and the minimum will be 1 month as per stepped-wedge c-RCT design. All participants will complete a My Guideline Implementation Barometer (MGIB) questionnaire at month 4.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Réseau Provincial De Recherche En Adaptation-Réadaptation (REPAR)
- Responsible party
- Principal investigator, Aliki Thomas, McGill University
- Investigators
- Aliki Thomas, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807115
- Sponsor's protocol ID
- CPSR-REPAR Research Award
- Status last verified
- Feb 2021
- First submitted
- 21 Dec 2018
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 12161823Korner-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.
PubMed 18382825Salbach 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.
PubMed 19372171Salbach 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.
PubMed 21040248Rochette 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.
PubMed 17724549Cahill 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.
PubMed 33058172
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03807115
- Acronym / sponsor ID
- CPSR-REPAR Research Award
- Keywords
- Stroke, Rehabilitation, Knowledge translation intervention, Walking capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Réseau Provincial De Recherche En Adaptation-Réadaptation (REPAR)
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pilot stepped-wedge c-RCT. Data collection will take place over 16 weeks at 6 sites. Patient chart data (Functional Independence Measure (FIM), Functional Ambulation Category (FAC), 6-Minute-Walk-Test) will be collected weekly at all sites. Weeks 1-12: Participants at sites 1-6 will submit a weekly Calculation of Indicators (COI). Weeks 1-12: Sites 1 and 2 will receive 4 weekly online intervention packages and submit Information Assessment Method (IAM) and COI questionnaires for 12 weeks. Weeks 5-12: Sites 3 and 4 will receive 4 weekly online intervention packages and submit IAM and COI questionnaires for 8 weeks. Weeks 9-12: Sites 5 and 6 will receive 4 weekly online intervention packages and submit IAM and COI questionnaires for a total of 4 weeks. The longest exposure to the intervention will be 3 months and the minimum will be 1 month as per stepped-wedge c-RCT design. All participants will complete a My Guideline Implementation Barometer (MGIB) questionnaire at month 4.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Implementation of stroke mobility guidelinesArm: Intervention: Implementation of stroke mobility guidelines |
| Control | No intervention | –Arm: Control: Usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Occupational or physical therapists who are currently participating in another knowledge translation study directed at enhancing practice in mobility training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of stroke mobility guidelinesDelivery 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. | Other | Intervention |
Primary outcome
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
Functional Independence Measure
Time frame: 1-3 months
7-level measurement of functional independence (1=total assist; 7=complete independence)
Functional Ambulation Category
Time frame: 1-3 months
6-point measurement of functional ambulation (0=nonfunctional ambulation; 5=ambulator independent)
5 secondary outcomes
Information Assessment Method
Time frame: 1-3 months
Clinician-reported feedback on caseload (Calculation of Indicators)
Time frame: 1-3 months
Clinician-reported feedback on delivery of interventions (Calculation of Indicators)
Time frame: 1-3 months
Clinician-reported feedback on confidence level in ability to deliver interventions (Calculation of Indicators)
Time frame: 1-3 months
My Guidelines Implementation Barometer
Time frame: 1-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Background: PubMed 12161823Mayo 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.
- Background: PubMed 18382825Korner-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.
- Background: PubMed 19372171Salbach 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.
- Background: PubMed 21040248Salbach 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.
- Background: PubMed 17724549Rochette 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.
- Derived from this study: PubMed 33058172Cahill 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliki Thomas, PhD principal investigator
McGill University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of stroke mobility guidelines in people with Stroke and Knowledge, Attitudes, Practice, run by McGill University at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six minute walk test (walking ability) (time frame: 1-3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03807115, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.