Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

Sponsor

University of British Columbia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04238260

Collaborator

(none)

200

Enrollment

Location

Arms

47.2

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Cerebral Infarction Brain Ischemia Infarction, Brain	Behavioral: Enhancing Physical Therapy Usual Care Behavioral: Physical Therapy Usual Care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention 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").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 (Outcomes Assessor)

Masking Description:

Assessors at each site will be blinded to intervention. Site study coordinators will be unblinded.

Primary Purpose:

Treatment

Official Title:

Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

Actual Study Start Date :

Apr 25, 2021

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Six-minute walk test at post intervention [4 weeks]
This test measures distance a participant can walk in 6 minutes.

Secondary Outcome Measures

Six-minute walk test at 12 months [12 months post-stroke]
This test measures distance a participant can walk in 6 minutes.
Blood pressure post intervention [12 months post-stroke]
Blood pressure measures physiological effects of the intervention
Quality of life from Euro-QOL 5D-5L at post intervention [12 months post-stroke]
This test is the most widely used instrument to measure quality of life.
Cognition from the Montreal Cognitive Assessment at 12 months post stroke [12 months post-stroke]
This test measures levels of cognitive impairment.
Lower extremity function from baseline using the short performance physical battery at 12 months post stroke [12 months post-stroke]
This test measures levels of lower extremity function.
Depression using the Patient Health Questionnaire-9 (PHQ-9) at 12 months post-stroke [12 months post-stroke]
This test screens for depression
Degree of disability using the Modified Rankin Scale (mRS) at 12 months post-stroke [12 months post-stroke]
This scale measures the degree of disability. Score range: minimum 0 to maximum 6. Lower score means a better outcome.
Amount of physical activity 12 months after stroke using the 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 after stroke [12 months post stroke]
The number of steps per day over 3 days

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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