Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

Not Applicable

Active, not recruiting

• Conditions: Infarction, Brain; Stroke; Brain Ischemia; Cerebral Infarction
• Interventions: Behavioral: Physical Therapy Usual Care; Behavioral: Enhancing Physical Therapy Usual Care

• Registration Number: NCT04238260
• Lead Sponsor: University of British Columbia

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-23
• Study Start: 2021-04-25
• Primary Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 307

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Usual Physical Therapy Care	Physical Therapy Usual Care	Physical Therapists continue usual care
Enhanced Physical Therapy Usual Care	Enhancing Physical Therapy Usual Care	Best practice implemented

Primary Outcome Measures

Name	Time	Method
Six-minute walk Test	4 weeks	This test measures distance a participant can walk in 6 minutes.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	4 weeks & 12 months post-stroke	Blood pressure measures physiological effects of the intervention
Six-minute walk test	12 months post-stroke	This test measures distance a participant can walk in 6 minutes.
Montreal Cognitive Assessment	4 weeks & 12 months post-stroke	This test measures levels of cognitive function.
Short performance physical battery	4 weeks & 12 months post-stroke	This test measures levels of lower extremity function.
Patient Health Questionnaire-9 (PHQ-9)	4 weeks & 12 months post-stroke	This test screens for depression
Modified Rankin Scale (mRS)	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.
Euro-QOL 5D-5L	4 weeks & 12 months post-stroke	This test is the most widely used instrument to measure quality of life.
Physical Activity Scale for the Elderly (PASE)	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
Step activity monitor	12 months post stroke	The number of steps per day over 3 days

Trial Locations

Locations (1)

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada