Stroke, AcuteFIRST-INNCT05393661
Focused Intensive Repeated Stepping During Inpatient Rehabilitation Poststroke - A Quality Improvement Project
An observational study of Stroke, Acute and Gait, Hemiplegic, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Stroke, Acute, Gait, Hemiplegic
- What is being tested?
- inpatient physical therapy poststroke
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals admitted to the Rehabilitation Hospital of Indiana for acute inpatient rehabilitation poststroke
Who may be able to join
- < 2 months poststroke
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254
About this study
Official title: Implementation of Focused Intensive Repeated Stepping Training (FIRST) During Inpatient Rehabilitation Poststroke - A Quality Improvement Project
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.
Read the 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.
- Conditions
- Stroke, Acute, Gait, Hemiplegic
- Being tested
- inpatient physical therapy poststroke
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inpatient physical therapy poststrokeOther
routine care
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing inpatient rehabilitation poststroke | Inpatient rehabilitation poststroke Receives: Other: inpatient physical therapy poststroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 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
Measured: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 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
Measured: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.
Secondary outcomes (5)
Change in Berg Balance Scale
Differences in performance on a 14 item static balance assessment of BERG Balance Scale (BBS). The Berg Balance Scale has a minimum value of 0 and a maximum value of 56. Higher scores means a higher performance on this test.
Measured: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.
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
Measured: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.
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
Measured: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.
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
Measured: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.
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
Measured: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Jan 2017
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- ACL Administration for Community Living, Shirley Ryan AbilityLab
- Responsible party
- Principal investigator, George Hornby, Indiana University
- Investigators
- Thomas G Hornby, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393661
- Sponsor's protocol ID
- 1608161738
- Acronym
- FIRST-IN
- Status last verified
- Jul 2026
- First submitted
- 16 May 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Focused Intensive Repeated Stepping Training (FIRST) During Inpatient Rehabilitation Poststroke - A Quality Improvement Project
- ClinicalTrials.gov ID
- NCT05393661
- Acronym / sponsor ID
- FIRST-IN / 1608161738
- Conditions
- Stroke, Acute, Gait, Hemiplegic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- ACL Administration for Community Living, Shirley Ryan AbilityLab
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing inpatient rehabilitation poststroke | – | Other: inpatient physical therapy poststrokeInpatient rehabilitation poststroke |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals admitted to the Rehabilitation Hospital of Indiana for acute inpatient rehabilitation poststroke
Key inclusion criteria (1 listed)
- < 2 months poststroke
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inpatient physical therapy poststrokeroutine care | Other | Patients undergoing inpatient rehabilitation poststroke |
Primary outcome
Change in 10 meter walk test
Time frame: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 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
Change in 6 minute walk test
Time frame: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 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
Change in 6 minute walk test level of assistance
Time frame: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.
Differences in amount of physical assistance provided by physical therapist during 6 minute walk test
5 secondary outcomes
Change in Berg Balance Scale
Time frame: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.
Change in Functional Independence Measure - bed to chair transfer subscore
Time frame: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.
Change in Functional Independence Measure - toilet transfer subscore
Time frame: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.
Change in Functional Independence Measure - locomotion
Time frame: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.
Change in Functional Independence Measure - stairs
Time frame: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified data available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas G Hornby principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Gait, Hemiplegic, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 10 meter walk test (time frame: Time from admission date & discharge date from inpatient rehabilitation. Time frame through inpatient stay completion, an average of 20 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.