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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05393661
Other study ID # 1608161738
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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