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

NCT05393661 | Recruiting

• 1 other identifier: 1608161738
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute; Gait, Hemiplegic

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Change in Berg Balance Scale

  Time from admission & discharge inpatient rehabilitation or approximately 20 days

• Change in Functional Independence Measure - bed to chair transfer subscore

  Time from admission & discharge inpatient rehabilitation or approximately 20 days

• Change in Functional Independence Measure - toilet transfer subscore

  Time from admission & discharge inpatient rehabilitation or approximately 20 days

• Change in Functional Independence Measure - locomotion

  Time from admission & discharge inpatient rehabilitation or approximately 20 days

• Change in Functional Independence Measure - stairs

  Time from admission & discharge inpatient rehabilitation or approximately 20 days

Other Outcomes (2)

• Incidence of significant adverse events

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

• Incidence of falls without injuries

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

Study Arms (1)

Patients undergoing inpatient rehabilitation poststroke

Inpatient rehabilitation poststroke

Other: inpatient physical therapy poststroke

Interventions

inpatient physical therapy poststroke OTHER

routine care

Patients undergoing inpatient rehabilitation poststroke

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals admitted to the Rehabilitation Hospital of Indiana for acute inpatient rehabilitation poststroke

You may qualify if:

• \< 2 months poststroke

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• ACL Administration for Community Living: collaborator
• Shirley Ryan AbilityLab: collaborator

Study Sites (1)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas G Hornby

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas G Hornby, PhD

CONTACT

3173292353; tghornby@iu.edu

Chris Henderson, PhD

CONTACT

3173292353; henderce@iu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Medicine and Rehab

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 26, 2022
• Study Start: January 1, 2017
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: after completion of study for 3 years

Locations

US (1)