Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03807115
Other study ID # CPSR-REPAR Research Award
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 24, 2020
Est. completion date December 31, 2021

Study information

Verified date February 2021
Source McGill University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 37
Est. completion date December 31, 2021
Est. primary completion date October 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Canada Nova Scotia Health Authority Halifax Nova Scotia
Canada Nanaimo General Hospital Nanaimo British Columbia
Canada St. John's Rehab - Sunnybrook Hospital North York Ontario
Canada Wascana Rehabilitation Centre Regina Saskatchewan
Canada Bridgepoint Rehabilitation Hospital Toronto Ontario
Canada Riverview Health Centre Winnipeg Manitoba

Sponsors (3)

Lead Sponsor Collaborator
McGill University Heart and Stroke Foundation of Canada - Canadian Partnership for Stroke Recovery, Réseau Provincial De Recherche En Adaptation-Réadaptation (REPAR)

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View Citation

Mayo NE, Wood-Dauphinee S, Côté R, Durcan L, Carlton J. Activity, participation, and quality of life 6 months poststroke. Arch Phys Med Rehabil. 2002 Aug;83(8):1035-42. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Six minute walk test (walking ability) Measurement of the total distance walked over six minutes on a hard, flat surface 1-3 months
Primary Functional Independence Measure 7-level measurement of functional independence (1=total assist; 7=complete independence) 1-3 months
Primary Functional Ambulation Category 6-point measurement of functional ambulation (0=nonfunctional ambulation; 5=ambulator independent) 1-3 months
Secondary Information Assessment Method Clinician-reported feedback on weekly delivery and retrieval of health information provided in educational capsules 1-3 months
Secondary Clinician-reported feedback on caseload (Calculation of Indicators) Number of patients with stroke treated per week 1-3 months
Secondary Clinician-reported feedback on delivery of interventions (Calculation of Indicators) Duration of interventions delivered per stroke patient per week (in 5 minute increments) 1-3 months
Secondary 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) 1-3 months
Secondary 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. 1-3 months
See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Recruiting NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT05993221 - Deconstructing Post Stroke Hemiparesis