Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

NCT04238260 | Completed DMC

• 1 other identifier: H19-02809
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cerebral Infarction; Brain Ischemia; Infarction, Brain

Keywords

Stroke; Lower extremity; Rehabilitation; Wearable device; Exercise; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Six-minute walk Test

  This test measures distance a participant can walk in 6 minutes.

  4 weeks

Secondary Outcomes (9)

• Six-minute walk test

  12 months post-stroke

• Blood pressure

  4 weeks & 12 months post-stroke

• Euro-QOL 5D-5L

  4 weeks & 12 months post-stroke

• Montreal Cognitive Assessment

  4 weeks & 12 months post-stroke

• Short performance physical battery

  4 weeks & 12 months post-stroke

Study Arms (2)

Usual Physical Therapy Care

ACTIVE COMPARATOR

Physical Therapists continue usual care

Behavioral: Physical Therapy Usual Care

Enhanced Physical Therapy Usual Care

EXPERIMENTAL

Best practice implemented

Behavioral: Enhancing Physical Therapy Usual Care

Interventions

Enhancing Physical Therapy Usual Care 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.

Enhanced Physical Therapy Usual Care

Physical Therapy Usual Care BEHAVIORAL

Usual physical therapy

Usual Physical Therapy Care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V5Z2G9, Canada

Location

Related Publications (4)

• Ackerley S, Hung SH, Sheehy L, Donkers SJ, Timofeeva P, Best KL, Peters S, Park SS, Ouellet B, Ezeugwu VE, Milot MH, Sakakibara BM, Eng JJ, Connell LA. Exploring factors influencing implementation across the explanatory-to-pragmatic trial continuum: a sequential qualitative integration of delivering higher-intensity walking exercise within inpatient stroke rehabilitation. Implement Sci Commun. 2026 Jan 8. doi: 10.1186/s43058-025-00812-y. Online ahead of print.

  PMID: 41508158 DERIVED

• Hung SH, Ackerley S, Connell LA, Bayley MT, Best KL, Donkers SJ, Dukelow SP, Ezeugwu VE, Milot MH, Peters S, Sakakibara BM, Sheehy L, Yao J, Eng JJ. Real-World Experiences of Therapy Staff Implementing an Intensive Rehabilitation Protocol in Canadian Stroke Inpatient Rehabilitation Settings: A Multi-Site Survey Study. Phys Ther. 2025 Oct 1;105(10):pzaf111. doi: 10.1093/ptj/pzaf111.

  PMID: 41139309 DERIVED

• Yan Y, Eng JJ, Hung SH, Bayley MT, Best KL, Connell LA, Donkers SJ, Dukelow SP, Ezeugwu VE, Milot MH, Sakakibara BM, Sheehy L, Wong H, Yao J, Peters S. Aerobic minutes and step number remain low in inpatient stroke rehabilitation. PLoS One. 2025 Jul 28;20(7):e0328930. doi: 10.1371/journal.pone.0328930. eCollection 2025.

  PMID: 40720450 DERIVED

• Peters S, Hung SH, Bayley MT, Best KL, Connell LA, Donkers SJ, Dukelow SP, Ezeugwu VE, Milot MH, Sakakibara BM, Sheehy L, Wong H, Yang Y, Yao J, Eng JJ. Safety and effectiveness of the Walk 'n Watch structured, progressive exercise protocol delivered by physical therapists for inpatient stroke rehabilitation in Canada: a phase 3, multisite, pragmatic, stepped-wedge, cluster-randomised controlled trial. Lancet Neurol. 2025 Aug;24(8):643-655. doi: 10.1016/S1474-4422(25)00201-7.

  PMID: 40683274 DERIVED

MeSH Terms

Conditions

Stroke; Cerebral Infarction; Brain Ischemia; Brain Infarction; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Behavior

Study Officials

• Janice J Eng, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors at each site will be blinded to intervention. Site study coordinators will be unblinded.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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").

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 23, 2020
• Study Start: April 25, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)