Focused Intensive Repeated Stepping During Inpatient Rehabilitation Poststroke - A Quality Improvement Project

NCT ID: NCT05393661

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2030-12-31

Brief Summary

The purpose of this quality improvement project was first to monitor usual physical therapy care (types & cardiovascular intensity of interventions and amount of stepping practice provided) and outcomes. Following which educational training and support was provided to treating physical therapists to encourage implementation of evidence-based practices. Specifically, therapists were encouraged to prioritize the practice of walking, particularly at higher cardiovascular intensities during scheduled therapy sessions. Fidelity metrics in the form of chart audits and pedometer-based step counts were utilized to determine compliance with the evidence-based intervention and ultimately investigated for potential effects on patient outcome measures.

Detailed Description

Converging data over the past 20 years suggest that the provision of large amounts of walking practice can improve walking function for individuals poststroke with greater improvements observed when the walking training is performed at moderate to high aerobic intensities. Despite this, current physical therapy practice during inpatient rehabilitation suggests limited walking practice is provided and low cardiovascular intensities achieved.

The purpose of this current quality improvement project is to evaluate the feasibility of implementing Focused, Intensive, Repeated Stepping Training (FIRST) during routine inpatient physical therapy and potential effects on patient outcome measures.

Prior to the usual care phase of the project, the outcome measures team worked to standardize routine collection of specific outcome measures (10 meter walk test, 6 minute walk test, Berg Balance Scale) at regular intervals (admission, weekly, discharge) in addition to 3rd party payer mandated measures (e.g., Functional Independence Measure; FIM). After which, existing physical therapy practice and outcomes will be monitored for a period of approximately 9-12 months. After which, educational training will be provided to physical therapists associated with the management of these patients as well as ongoing support (e.g., didactic, psychomotor, technical) and audit/feedback (e.g., chart audits, step count feedback) with fidelity metrics monitored from chart audits (walking practiced, walking prioritized, cardiovascular intensity documented, target intensity achieved) and pedometer step counts.

Potential changes in locomotor (e.g., 10 meter walk test, 6 minute walk test), non-locomotor outcomes (Berg Balance Scale, FIM-bed to chair transfers, FIM - toilet transfers), and incidence of adverse events will be evaluated if fidelity metrics indicate meaningful changes in clinical practice patterns. It is currently unknown what values of the fidelity metrics indicate successful implementation of the FIRST intervention, what knowledge translation strategies may be most effective to yield changes in therapists practice patterns, or the duration of time necessary to sufficiently achieve these changes in practice.

Conditions

Stroke, Acute; Gait, Hemiplegic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Patients undergoing inpatient rehabilitation poststroke

Inpatient rehabilitation poststroke

inpatient physical therapy poststroke

Intervention Type: OTHER

routine care

Interventions

inpatient physical therapy poststroke

routine care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• < 2 months poststroke

Exclusion Criteria

• restrictions in lower extremity weightbearing (e.g., amputation or lower limb fracture)
• unable to ambulate > 50 m prior to their most recent stroke
• discharged to home from inpatient rehabilitation after < 1 week

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ACL Administration for Community Living

UNKNOWN

Sponsor Role: collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

George Hornby

Professor of Physical Medicine and Rehab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas G Hornby

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Thomas G Hornby, PhD

Role: CONTACT

tghornby@iu.edu

3173292353

Chris Henderson, PhD

Role: CONTACT

henderce@iu.edu

3173292353

Facility Contacts

George Hornby

Role: primary

tghornby@iu.edu

317-329-2353

Other Identifiers

1608161738

Identifier Type: -

Identifier Source: org_study_id