Focused Intensive Repeated Stepping During Inpatient Rehabilitation Poststroke - A Quality Improvement Project (FIRST-IN)

Implementation of Focused Intensive Repeated Stepping Training (FIRST) During Inpatient Rehabilitation Poststroke - A Quality Improvement Project

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute; Gait, Hemiplegic
• Intervention / Treatment: Other: inpatient physical therapy poststroke

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Thomas G Hornby, PhD; Phone Number: 3173292353; Email: tghornby@iu.edu
• Study Contact Backup: Name: Chris Henderson, PhD; Phone Number: 3173292353; Email: henderce@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46254
      • Recruiting
      • Rehabilitation Hospital of Indiana
      • Contact: George Hornby; Phone Number: 317-329-2353; Email: tghornby@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals admitted to the Rehabilitation Hospital of Indiana for acute inpatient rehabilitation poststroke

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing inpatient rehabilitation poststroke; Inpatient rehabilitation poststroke	Other: inpatient physical therapy poststroke; routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 10 meter walk test	Differences in time for individual to ambulate 10 meters (with middle 6 meters timed) with directions "walk at your usual, comfortable pace" from admission and discharge from inpatient rehabilitation	Time from admission & discharge inpatient rehabilitation or approximately 20 days
Change in 6 minute walk test	Differences in distance able to be ambulated during a 6 minute period with directions "cover as much ground as possible" from admission and discharge from inpatient rehabilitation	Time from admission & discharge inpatient rehabilitation or approximately 20 days
Change in 6 minute walk test level of assistance	Differences in amount of physical assistance provided by physical therapist during 6 minute walk test	Time from admission & discharge inpatient rehabilitation or approximately 20 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Berg Balance Scale	Differences in performance on a 14 item static balance assessment	Time from admission & discharge inpatient rehabilitation or approximately 20 days
Change in Functional Independence Measure - bed to chair transfer subscore	Differences in performance during task assessed using an ordinal score (0-7) for amount of physical assistance necessary to complete functional task	Time from admission & discharge inpatient rehabilitation or approximately 20 days
Change in Functional Independence Measure - toilet transfer subscore	Differences in performance during task assessed using an ordinal score (0-7) for amount of physical assistance necessary to complete functional task	Time from admission & discharge inpatient rehabilitation or approximately 20 days
Change in Functional Independence Measure - locomotion	Differences in performance during task assessed using an ordinal score (0-7) for amount of physical assistance necessary and distance covered during level overground ambulation	Time from admission & discharge inpatient rehabilitation or approximately 20 days
Change in Functional Independence Measure - stairs	Differences in performance during task assessed using an ordinal score (0-7) for amount of physical assistance necessary and number of stairs able to be negotiated	Time from admission & discharge inpatient rehabilitation or approximately 20 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of significant adverse events	Includes death, new cerebrovascular events, or rehospitalization	Throughout time from admission & discharge inpatient rehabilitation or approximately 20 days
Incidence of falls without injuries	Medical documentation indicating a fall without an associated significant adverse event	Throughout time from admission & discharge inpatient rehabilitation or approximately 20 days

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Shirley Ryan AbilityLab; ACL Administration for Community Living
• Investigators: Principal Investigator: Thomas G Hornby, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Gait Disorders, Neurologic
• Other Study ID Numbers: 1608161738; 13178 (OTHER: Indiana University IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data available upon reasonable request
• IPD Sharing Time Frame: after completion of study for 3 years

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No