Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Brain Ischemia; Cerebral Infarction; Infarction, Brain
• Intervention / Treatment: Behavioral: Physical Therapy Usual Care; Behavioral: Enhancing Physical Therapy Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 306
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z2G9
      • University of British Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Physical Therapy Care; Physical Therapists continue usual care	Behavioral: Physical Therapy Usual Care; Usual physical therapy
Experimental: Enhanced Physical Therapy Usual Care; Best practice implemented	Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Janice J Eng, PhD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2021
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Stroke; Clinical Trial; Lower extremity; Wearable device
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Necrosis; Ischemia; Stroke; Cerebral Infarction; Infarction; Brain Ischemia; Brain Infarction
• Other Study ID Numbers: H19-02809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If required by journal for publication, the following individual participant data will be entered into a repository: age in years, sex, and outcomes as described above.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No