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

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05393661
Collaborator
National Institute on Disability, Independent Living, and Rehabilitation Research (U.S. Fed), National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
2,000
1
168
11.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Implementation of Focused Intensive Repeated Stepping Training (FIRST) During Inpatient Rehabilitation Poststroke - A Quality Improvement Project
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2030
Anticipated Study Completion Date :
Dec 31, 2030

Arms and Interventions

Arm Intervention/Treatment
Patients undergoing inpatient rehabilitation poststroke

Inpatient rehabilitation poststroke

Other: inpatient physical therapy poststroke
routine care

Outcome Measures

Primary Outcome Measures

  1. Change in 10 meter walk test [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 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 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 Outcome Measures

  1. Change in Berg Balance Scale [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 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 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 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 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 Outcome Measures

  1. Incidence of significant adverse events [Throughout time from admission & discharge inpatient rehabilitation or approximately 20 days]

    Includes death, new cerebrovascular events, or rehospitalization

  2. Incidence of falls without injuries [Throughout time from admission & discharge inpatient rehabilitation or approximately 20 days]

    Medical documentation indicating a fall without an associated significant adverse event

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rehabilitation Hospital of Indiana Indianapolis Indiana United States 46254

Sponsors and Collaborators

  • Indiana University
  • National Institute on Disability, Independent Living, and Rehabilitation Research
  • National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Thomas G Hornby, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
George Hornby, Professor of Physical Medicine and Rehab, Indiana University
ClinicalTrials.gov Identifier:
NCT05393661
Other Study ID Numbers:
  • 1608161738
  • 13178
First Posted:
May 26, 2022
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2022