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

Stroke, Acute Clinical Trial

— FIRST-IN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05393661
• Other study ID #: 1608161738
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: December 31, 2030

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: Thomas G Hornby, PhD
• Phone: 3173292353
• Email: tghornby[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Stroke
• Stroke, Acute

Intervention

Other:
• inpatient physical therapy poststroke
routine care

Locations

Country	Name	City	State
United States	Rehabilitation Hospital of Indiana	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	ACL Administration for Community Living, Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of significant adverse events	Includes death, new cerebrovascular events, or rehospitalization	Throughout time from admission & discharge inpatient rehabilitation or approximately 20 days
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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