Clinical trial NCT05393661: Focused Intensive Repeated Stepping During Inpatient Rehabilitation Poststroke - A Quality Improvement Project
Official title: Implementation of Focused Intensive Repeated Stepping Training (FIRST) During Inpatient Rehabilitation Poststroke - A Quality Improvement Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Gait, Hemiplegic
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: ACL Administration for Community Living
name: Shirley Ryan AbilityLab
First posted: 2022-05-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals admitted to the Rehabilitation Hospital of Indiana for acute inpatient rehabilitation poststroke

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.

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

Primary outcomes:
measure: Change in 10 meter walk test
timeFrame: Time from admission & discharge inpatient rehabilitation or approximately 20 days
measure: Change in 6 minute walk test
timeFrame: Time from admission & discharge inpatient rehabilitation or approximately 20 days
measure: Change in 6 minute walk test level of assistance
timeFrame: Time from admission & discharge inpatient rehabilitation or approximately 20 days
Secondary outcomes:
measure: Change in Berg Balance Scale
timeFrame: Time from admission & discharge inpatient rehabilitation or approximately 20 days
measure: Change in Functional Independence Measure - bed to chair transfer subscore
timeFrame: Time from admission & discharge inpatient rehabilitation or approximately 20 days
measure: Change in Functional Independence Measure - toilet transfer subscore
timeFrame: Time from admission & discharge inpatient rehabilitation or approximately 20 days
measure: Change in Functional Independence Measure - locomotion
timeFrame: Time from admission & discharge inpatient rehabilitation or approximately 20 days
measure: Change in Functional Independence Measure - stairs
timeFrame: Time from admission & discharge inpatient rehabilitation or approximately 20 days
Other outcomes:
measure: Incidence of significant adverse events
timeFrame: Throughout time from admission & discharge inpatient rehabilitation or approximately 20 days
measure: Incidence of falls without injuries
timeFrame: Throughout time from admission & discharge inpatient rehabilitation or approximately 20 days
Locations:
city: Indianapolis
country: United States
facility: Rehabilitation Hospital of Indiana
state: Indiana
Study officials:
affiliation: Indiana University
name: Thomas G Hornby
role: PRINCIPAL_INVESTIGATOR
References: