Brain Ischemia, Cerebral Infarction, Infarction, Brain, Stroke
Conditions
Keywords
Stroke, Lower extremity, Rehabilitation, Wearable device, Exercise, Clinical Trial
Brief summary
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
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.
Interventions
BEHAVIORALEnhancing Physical Therapy Usual Care
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.
BEHAVIORALPhysical Therapy Usual Care
Usual physical therapy
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors at each site will be blinded to intervention. Site study coordinators will be unblinded.
Intervention 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").
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute walk Test | 4 weeks | This test measures distance a participant can walk in 6 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute walk test | 12 months post-stroke | This test measures distance a participant can walk in 6 minutes. |
| Blood pressure | 4 weeks & 12 months post-stroke | Blood pressure measures physiological effects of the intervention |
| Euro-QOL 5D-5L | 4 weeks & 12 months post-stroke | This test is the most widely used instrument to measure quality of life. |
| Montreal Cognitive Assessment | 4 weeks & 12 months post-stroke | This test measures levels of cognitive function. Min 0, max 30, with higher scores reflecting better cognition. |
| Short Performance Physical Battery | 4 weeks & 12 months post-stroke | This test measures lower extremity function. Min value 0, max value 12. Higher scores reflect better lower extremity function |
| Patient Health Questionnaire-9 (PHQ-9) | 4 weeks & 12 months post-stroke | This test screens for depression. Min 0, max 27. Higher values reflect more severe symptoms. |
| Modified Rankin Scale (mRS) | 4 weeks & 12 months post-stroke | This scale measures the degree of disability. Score range: minimum 0 to maximum 6. Lower score means a better outcome. |
| Physical Activity Scale for the Elderly (PASE) | 12 months post-stroke | 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 |
| Step activity monitor | 12 months post stroke | The number of steps per day over 3 days |
| Gait speed | 4 week and 12 month post-stroke | self-paced gait speed in metre/second |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORJanice J Eng, PhD
University of British Columbia
Outcome results
None listed