Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

Stroke Clinical Trial

Official title:

Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04238260
• Other study ID #: H19-02809
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 25, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 307
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Infarction
• Brain Ischemia
• Cerebral Infarction
• Infarction
• Infarction, Brain
• Stroke

Intervention

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.
• Physical Therapy Usual Care
Usual physical therapy

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-minute walk Test	This test measures distance a participant can walk in 6 minutes.	4 weeks
Secondary	Six-minute walk test	This test measures distance a participant can walk in 6 minutes.	12 months post-stroke
Secondary	Blood pressure	Blood pressure measures physiological effects of the intervention	4 weeks & 12 months post-stroke
Secondary	Euro-QOL 5D-5L	This test is the most widely used instrument to measure quality of life.	4 weeks & 12 months post-stroke
Secondary	Montreal Cognitive Assessment	This test measures levels of cognitive function.	4 weeks & 12 months post-stroke
Secondary	Short performance physical battery	This test measures levels of lower extremity function.	4 weeks & 12 months post-stroke
Secondary	Patient Health Questionnaire-9 (PHQ-9)	This test screens for depression	4 weeks & 12 months post-stroke
Secondary	Modified Rankin Scale (mRS)	This scale measures the degree of disability. Score range: minimum 0 to maximum 6. Lower score means a better outcome.	4 weeks & 12 months post-stroke
Secondary	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	12 months post-stroke
Secondary	Step activity monitor	The number of steps per day over 3 days	12 months post stroke