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StrokeNCT04238260

Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

A study of Stroke and Cerebral Infarction, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Stroke, Cerebral Infarction, Brain Ischemia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
306 participants
Where
1 siteCanada
Study dates
25 Apr 2021to 30 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of British Columbia

    Vancouver, British Columbia, V5Z2G9

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Enhancing Physical Therapy Usual Care, Physical Therapy Usual Care
Keywords
Stroke, Lower extremity, Rehabilitation, Wearable device, Exercise, Clinical Trial
Medical subject headings
Stroke, Cerebral Infarction, Brain Ischemia, Brain Infarction, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhancing Physical Therapy Usual CareBehavioural

    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.

  • Physical Therapy Usual CareBehavioural

    Usual physical therapy

Study groups in NCT04238260
Study groupRoleWhat they receive
Usual Physical Therapy CareActive comparatorPhysical Therapists continue usual care
Receives: Behavioral: Physical Therapy Usual Care
Enhanced Physical Therapy Usual CareExperimentalBest practice implemented
Receives: Behavioral: Enhancing Physical Therapy Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Six-minute walk Test

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

    Measured: 4 weeks

Secondary outcomes (10)

  1. Six-minute walk test

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

    Measured: 12 months post-stroke

  2. Blood pressure

    Blood pressure measures physiological effects of the intervention

    Measured: 4 weeks & 12 months post-stroke

  3. Euro-QOL 5D-5L

    This test is the most widely used instrument to measure quality of life.

    Measured: 4 weeks & 12 months post-stroke

  4. Montreal Cognitive Assessment

    This test measures levels of cognitive function. Min 0, max 30, with higher scores reflecting better cognition.

    Measured: 4 weeks & 12 months post-stroke

  5. Short Performance Physical Battery

    This test measures lower extremity function. Min value 0, max value 12. Higher scores reflect better lower extremity function

    Measured: 4 weeks & 12 months post-stroke

  6. Patient Health Questionnaire-9 (PHQ-9)

    This test screens for depression. Min 0, max 27. Higher values reflect more severe symptoms.

    Measured: 4 weeks & 12 months post-stroke

  7. Modified Rankin Scale (mRS)

    This scale measures the degree of disability. Score range: minimum 0 to maximum 6. Lower score means a better outcome.

    Measured: 4 weeks & 12 months post-stroke

  8. 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

    Measured: 12 months post-stroke

  9. Step activity monitor

    The number of steps per day over 3 days

    Measured: 12 months post stroke

  10. Gait speed

    self-paced gait speed in metre/second

    Measured: 4 week and 12 month post-stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2020
  2. Study start25 Apr 2021
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
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").
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
306 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04238260
Sponsor's protocol ID
H19-02809
Status last verified
Jun 2026
First submitted
20 Jan 2020
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Tang WK, Lu H, Leung TWH, Fong KNK, Chan SKY, Liew VWJ. A double-blind randomized control trial of transcranial direct current stimulation in post-stroke fatigue. Front Neurol. 2026 May 7;17:1658764. doi: 10.3389/fneur.2026.1658764. eCollection 2026.

    PubMed 42180207

  • 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;7(1):44. doi: 10.1186/s43058-025-00812-y.

    PubMed 41508158

  • 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.

    PubMed 41139309

  • 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.

    PubMed 40720450

  • 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.

    PubMed 40683274

Questions about this trial

What is this clinical trial studying?

A study of Stroke and Cerebral Infarction, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six-minute walk Test (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04238260, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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Clinical Trial NCT04238260 | AzTrials