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Completed

NCT Number: NCT04238260

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Vancouver, British Columbia, V5Z2G9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Physical Therapy Usual Care

Behavioral

Usual physical therapy

Primary outcomes

  1. Six-minute walk Test

    Time frame: 4 weeks

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

Secondary outcomes

  1. Six-minute walk test

    Time frame: 12 months post-stroke

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

  2. Blood pressure

    Time frame: 4 weeks & 12 months post-stroke

    Blood pressure measures physiological effects of the intervention

  3. Euro-QOL 5D-5L

    Time frame: 4 weeks & 12 months post-stroke

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

  4. Montreal Cognitive Assessment

    Time frame: 4 weeks & 12 months post-stroke

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

  5. Short Performance Physical Battery

    Time frame: 4 weeks & 12 months post-stroke

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

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

    Time frame: 4 weeks & 12 months post-stroke

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

  7. Modified Rankin Scale (mRS)

    Time frame: 4 weeks & 12 months post-stroke

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

  8. Physical Activity Scale for the Elderly (PASE)

    Time frame: 12 months post-stroke

    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

  9. Step activity monitor

    Time frame: 12 months post stroke

    The number of steps per day over 3 days

  10. Gait speed

    Time frame: 4 week and 12 month post-stroke

    self-paced gait speed in metre/second

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jan 23, 2020
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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