Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

Study Overview
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Brief Summary
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The aim of this study is to assess the effect of implementing best practices into current stroke rehabilitation physical therapy on walking outcomes. Participants will also be provided an activity monitor to help them track and target their walking practice to determine if this can improve walking ability.

Detailed Description
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This multi-site study will have each site start in usual care with participants consented to collecting outcome measures. The twelve inpatient stroke units include: Kelowna General Hospital, Nanaimo Regional General Hospital, Glenrose Rehabilitation Hospital, Saskatoon City Hospital, Wascana Rehabilitation Centre, Joseph Brant Hospital, Bruyère Hospital, Freeport Grand River Hospital, CIUSSS-de-l'Estrie-CHUS Centre de réadaptation de l'Estrie, Centre interdisciplinaire de recherche en réadaptation et intégration sociale, Dr. Everett Chalmers Regional Hospital, and Queen Elizabeth Hospital. Each site will randomly switch over to Enhanced Usual Care (best practice implementation) where all physical therapists at the site will be educated on delivery of best practice for locomotor retraining. The specific therapy activities are at the discretion of the physical therapist; however, physical therapists must work towards thirty minutes of weight-bearing/stepping activity at greater than forty percent heart rate reserve. Participants will continue to be consented to collecting outcome measures. Additionally, participants will be given and trained to use activity watches to monitor their own progress.

Official Title
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Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

Conditions
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Stroke, Cerebral Infarction, Brain Ischemia, Infarction, Brain

Intervention / Treatment
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* Behavioral: Enhancing Physical Therapy Usual Care
* Behavioral: Physical Therapy Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted by inpatient or day stroke rehabilitation Improved walking is a rehabilitation goal Within 12 weeks post hemorrhagic or ischemic CVA with hemiparesis (confirmed by medical chart or motor assessment) Able to ambulate at least 5 steps. May use assistive and/or orthotic device and maximum one person assist Overground walking speed slower than normal Able to understand and follow directions Greater than or equal to 19 years of age Medically stable Exclusion Criteria: Pre-stroke health included a serious gait disorder or disease that affected ambulation (musculoskeletal conditions, amputation, surgery/arthroplasty in the last 6 months, etc.) Pre-stroke health included a neurological condition (such as Parkinson's disease or Multiple Sclerosis) or other serious medical condition (active cancer, uncontrolled diabetes) Excessive pain in the body/joint preventing participation in an exercise intervention Participating in an experimental drug field study Participating in another formal exercise rehabilitation clinical trial Expected to receive <2 weeks daily in-/out- patient rehabilitation

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: This clinical trial uses a stepped-wedge design. Unlike typical studies where participants are randomized to two different interventions, this design has all sites start in the Usual Care period, and then switch-over to Enhanced Care at predetermined times, which will then be the new Usual Care (termed Enhanced Usual Care).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Physical Therapy Care<br>Physical Therapists continue usual care | Behavioral: Physical Therapy Usual Care<br>* Usual physical therapy<br>|
| Experimental: Enhanced Physical Therapy Usual Care<br>Best practice implemented | Behavioral: Enhancing Physical Therapy Usual Care<br>* The protocol is focused on the completion of a minimum of 30 minutes of weight-bearing, walking-related activities that progressively increase in intensity informed by heart rate and step counters over 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walk Test | This test measures distance a participant can walk in 6 minutes. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walk test | This test measures distance a participant can walk in 6 minutes. | 12 months post-stroke | 
| Blood pressure | Blood pressure measures physiological effects of the intervention | 4 weeks & 12 months post-stroke | 
| Euro-QOL 5D-5L | This test is the most widely used instrument to measure quality of life. | 4 weeks & 12 months post-stroke | 
| Montreal Cognitive Assessment | This test measures levels of cognitive function. | 4 weeks & 12 months post-stroke | 
| Short performance physical battery | This test measures levels of lower extremity function. | 4 weeks & 12 months post-stroke | 
| Patient Health Questionnaire-9 (PHQ-9) | This test screens for depression | 4 weeks & 12 months post-stroke | 
| Modified Rankin Scale (mRS) | This scale measures the degree of disability. Score range: minimum 0 to maximum 6. Lower score means a better outcome. | 4 weeks & 12 months post-stroke | 
| Physical Activity Scale for the Elderly (PASE) | This test assesses physical activity, including leisure, household, and occupational activity. Score range: minimum 0 to maximum 400 or more. Higher score means a better outcome | 12 months post-stroke | 
| Step activity monitor | The number of steps per day over 3 days | 12 months post stroke | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Lower extremity, Rehabilitation, Wearable device, Exercise, Clinical Trial