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NCT Number: NCT05393661

Focused Intensive Repeated Stepping 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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

Location status: Recruiting

Location contact

George Hornby

CONTACT

[email protected]

317-329-2353

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inpatient physical therapy poststroke

Other

routine care

Primary outcomes

  1. Change in 10 meter walk test

    Time frame: Time from admission & discharge inpatient rehabilitation or approximately 20 days

    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

  2. Change in 6 minute walk test

    Time frame: Time from admission & discharge inpatient rehabilitation or approximately 20 days

    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

  3. Change in 6 minute walk test level of assistance

    Time frame: Time from admission & discharge inpatient rehabilitation or approximately 20 days

    Differences in amount of physical assistance provided by physical therapist during 6 minute walk test

Secondary outcomes

  1. Change in Berg Balance Scale

    Time frame: Time from admission & discharge inpatient rehabilitation or approximately 20 days

    Differences in performance on a 14 item static balance assessment

  2. Change in Functional Independence Measure - bed to chair transfer subscore

    Time frame: Time from admission & discharge inpatient rehabilitation or approximately 20 days

    Differences in performance during task assessed using an ordinal score (0-7) for amount of physical assistance necessary to complete functional task

  3. Change in Functional Independence Measure - toilet transfer subscore

    Time frame: Time from admission & discharge inpatient rehabilitation or approximately 20 days

    Differences in performance during task assessed using an ordinal score (0-7) for amount of physical assistance necessary to complete functional task

  4. Change in Functional Independence Measure - locomotion

    Time frame: Time from admission & discharge inpatient rehabilitation or approximately 20 days

    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

  5. Change in Functional Independence Measure - stairs

    Time frame: Time from admission & discharge inpatient rehabilitation or approximately 20 days

    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

Other outcomes

  1. Incidence of significant adverse events

    Time frame: Throughout time from admission & discharge inpatient rehabilitation or approximately 20 days

    Includes death, new cerebrovascular events, or rehospitalization

  2. Incidence of falls without injuries

    Time frame: Throughout time from admission & discharge inpatient rehabilitation or approximately 20 days

    Medical documentation indicating a fall without an associated significant adverse event

Study contacts

Contact information is provided by the study sponsor or research team.

Chris Henderson, PhD

CONTACT

[email protected]

3173292353

Thomas G Hornby, PhD

CONTACT

[email protected]

3173292353

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • ACL Administration for Community Living
  • Shirley Ryan AbilityLab

Registry information

Official study title

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

Acronym: FIRST-IN

Important dates

Study start
2017
Primary completion
2030
Study completion
2030
First posted
May 26, 2022
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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