Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-25

Study Completion Date

2025-04-30

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.

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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.

Conditions

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Stroke Cerebral Infarction Brain Ischemia Infarction, Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Assessors at each site will be blinded to intervention. Site study coordinators will be unblinded.

Study Groups

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Usual Physical Therapy Care

Physical Therapists continue usual care

Group Type ACTIVE_COMPARATOR

Physical Therapy Usual Care

Intervention Type BEHAVIORAL

Usual physical therapy

Enhanced Physical Therapy Usual Care

Best practice implemented

Group Type EXPERIMENTAL

Enhancing Physical Therapy Usual Care

Intervention Type BEHAVIORAL

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.

Interventions

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Enhancing 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.

Intervention Type BEHAVIORAL

Physical Therapy Usual Care

Usual physical therapy

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No