Clinical trial NCT04238260: Enhancing Physical Therapy Best Practice for Improving Walking After Stroke
Official title: Enhancing Physical Therapy Best Practice for Improving Walking After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cerebral Infarction
Brain Ischemia
Infarction, Brain
Keywords: Stroke
Lower extremity
Rehabilitation
Wearable device
Exercise
Clinical Trial
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 306
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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").
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Six-minute walk Test
timeFrame: 4 weeks
Secondary outcomes:
measure: Six-minute walk test
timeFrame: 12 months post-stroke
measure: Blood pressure
timeFrame: 4 weeks & 12 months post-stroke
measure: Euro-QOL 5D-5L
timeFrame: 4 weeks & 12 months post-stroke
measure: Montreal Cognitive Assessment
timeFrame: 4 weeks & 12 months post-stroke
measure: Short performance physical battery
timeFrame: 4 weeks & 12 months post-stroke
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 4 weeks & 12 months post-stroke
measure: Modified Rankin Scale (mRS)
timeFrame: 4 weeks & 12 months post-stroke
measure: Physical Activity Scale for the Elderly (PASE)
timeFrame: 12 months post-stroke
measure: Step activity monitor
timeFrame: 12 months post stroke
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Janice J Eng, PhD
role: PRINCIPAL_INVESTIGATOR
References: