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Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

Primary Purpose

Stroke, Cerebral Infarction, Brain Ischemia

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Enhancing Physical Therapy Usual Care

Physical Therapy Usual Care

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Lower extremity, Rehabilitation, Wearable device, Exercise, Clinical Trial

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of British ColumbiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Physical Therapy Care

Enhanced Physical Therapy Usual Care

Arm Description

Physical Therapists continue usual care

Best practice implemented

Outcomes

Primary Outcome Measures

Six-minute walk Test

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

Secondary Outcome Measures

Six-minute walk test

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

Blood pressure

Blood pressure measures physiological effects of the intervention

Euro-QOL 5D-5L

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

Montreal Cognitive Assessment

This test measures levels of cognitive function.

Short performance physical battery

This test measures levels of lower extremity function.

Patient Health Questionnaire-9 (PHQ-9)

This test screens for depression

Modified Rankin Scale (mRS)

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

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

Step activity monitor

The number of steps per day over 3 days

Full Information

NCT ID

NCT04238260

First Posted

January 20, 2020

Last Updated

January 30, 2023

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT04238260

Brief Title

Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

Official Title

Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 25, 2021 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Cerebral Infarction, Brain Ischemia, Infarction, Brain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

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

Outcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Usual Physical Therapy Care

Arm Type

Active Comparator

Arm Description

Physical Therapists continue usual care

Arm Title

Enhanced Physical Therapy Usual Care

Arm Type

Experimental

Arm Description

Best practice implemented

Intervention Type

Behavioral

Intervention Name(s)

Enhancing Physical Therapy Usual Care

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Physical Therapy Usual Care

Intervention Description

Usual physical therapy

Primary Outcome Measure Information:

Title

Six-minute walk Test

Description

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Six-minute walk test

Description

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

Time Frame

12 months post-stroke

Title

Blood pressure

Description

Blood pressure measures physiological effects of the intervention

Time Frame