Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 9:22 PM
Study NCT ID:
NCT05393661
Status:
RECRUITING
Last Update Posted:
2025-07-15
First Post:
2022-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focused Intensive Repeated Stepping During Inpatient Rehabilitation Poststroke - A Quality Improvement Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2022-05-16', 'studyFirstSubmitQcDate': '2022-05-23', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of significant adverse events', 'timeFrame': 'Throughout time from admission & discharge inpatient rehabilitation or approximately 20 days', 'description': 'Includes death, new cerebrovascular events, or rehospitalization'}, {'measure': 'Incidence of falls without injuries', 'timeFrame': 'Throughout time from admission & discharge inpatient rehabilitation or approximately 20 days', 'description': 'Medical documentation indicating a fall without an associated significant adverse event'}], 'primaryOutcomes': [{'measure': 'Change in 10 meter walk test', 'timeFrame': 'Time from admission & discharge inpatient rehabilitation or approximately 20 days', 'description': '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'}, {'measure': 'Change in 6 minute walk test', 'timeFrame': 'Time from admission & discharge inpatient rehabilitation or approximately 20 days', 'description': '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'}, {'measure': 'Change in 6 minute walk test level of assistance', 'timeFrame': 'Time from admission & discharge inpatient rehabilitation or approximately 20 days', 'description': 'Differences in amount of physical assistance provided by physical therapist during 6 minute walk test'}], 'secondaryOutcomes': [{'measure': 'Change in Berg Balance Scale', 'timeFrame': 'Time from admission & discharge inpatient rehabilitation or approximately 20 days', 'description': 'Differences in performance on a 14 item static balance assessment'}, {'measure': 'Change in Functional Independence Measure - bed to chair transfer subscore', 'timeFrame': 'Time from admission & discharge inpatient rehabilitation or approximately 20 days', 'description': 'Differences in performance during task assessed using an ordinal score (0-7) for amount of physical assistance necessary to complete functional task'}, {'measure': 'Change in Functional Independence Measure - toilet transfer subscore', 'timeFrame': 'Time from admission & discharge inpatient rehabilitation or approximately 20 days', 'description': 'Differences in performance during task assessed using an ordinal score (0-7) for amount of physical assistance necessary to complete functional task'}, {'measure': 'Change in Functional Independence Measure - locomotion', 'timeFrame': 'Time from admission & discharge inpatient rehabilitation or approximately 20 days', 'description': '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'}, {'measure': 'Change in Functional Independence Measure - stairs', 'timeFrame': 'Time from admission & discharge inpatient rehabilitation or approximately 20 days', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Acute', 'Gait, Hemiplegic']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nPrior 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.\n\nPotential 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals admitted to the Rehabilitation Hospital of Indiana for acute inpatient rehabilitation poststroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\< 2 months poststroke\n\nExclusion Criteria:\n\n* restrictions in lower extremity weightbearing (e.g., amputation or lower limb fracture)\n* unable to ambulate \\> 50 m prior to their most recent stroke\n* discharged to home from inpatient rehabilitation after \\< 1 week'}, 'identificationModule': {'nctId': 'NCT05393661', 'acronym': 'FIRST-IN', 'briefTitle': 'Focused Intensive Repeated Stepping During Inpatient Rehabilitation Poststroke - A Quality Improvement Project', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Implementation of Focused Intensive Repeated Stepping Training (FIRST) During Inpatient Rehabilitation Poststroke - A Quality Improvement Project', 'orgStudyIdInfo': {'id': '1608161738'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing inpatient rehabilitation poststroke', 'description': 'Inpatient rehabilitation poststroke', 'interventionNames': ['Other: inpatient physical therapy poststroke']}], 'interventions': [{'name': 'inpatient physical therapy poststroke', 'type': 'OTHER', 'description': 'routine care', 'armGroupLabels': ['Patients undergoing inpatient rehabilitation poststroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46254', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'George Hornby', 'role': 'CONTACT', 'email': 'tghornby@iu.edu', 'phone': '317-329-2353'}], 'facility': 'Rehabilitation Hospital of Indiana', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'centralContacts': [{'name': 'Thomas G Hornby, PhD', 'role': 'CONTACT', 'email': 'tghornby@iu.edu', 'phone': '3173292353'}, {'name': 'Chris Henderson, PhD', 'role': 'CONTACT', 'email': 'henderce@iu.edu', 'phone': '3173292353'}], 'overallOfficials': [{'name': 'Thomas G Hornby', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'timeFrame': 'after completion of study for 3 years', 'ipdSharing': 'YES', 'description': 'De-identified data available upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'ACL Administration for Community Living', 'class': 'UNKNOWN'}, {'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Physical Medicine and Rehab', 'investigatorFullName': 'George Hornby', 'investigatorAffiliation': 'Indiana University'}}}}