Clinical trial NCT02876783: Analysis of Stroke Rehabilitation Outcomes
Official title: Analysis of Stroke Rehabilitation Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only inpatients with a primary diagnosis of stroke who have been admitted to the inpatient rehabilitation unit (IRU) will be recruited for this study. Participants are medically stable (criteria for admission to the IRU) and have recently had a stroke.

Brief summary: Observe and describe the relationships between impairments and function, systematically characterize recovery patterns and examine short and long term rehabilitation outcomes. This project is purely observational, descriptive and non-experimental. N=273

Detailed description: This project involves an interdisciplinary stroke database of demographic variables and clinical measures collected during routine acute care, inpatient rehabilitation admission and discharge as well as follow up questionnaires at 6 month and 12 months to examine stroke recovery.

Our aim is to observe and describe the relationships between impairments and function, systematically characterize recovery patterns and examine short and long term rehabilitation outcomes.

This project is purely observational, descriptive and non experimental. No rehabilitation interventions or treatment procedures are being introduced, modified or studied.

Eligibility criteria: Inclusion Criteria:

Patients who have a confirmed primary diagnosis of cerebrovascular accident (CVA) as per radiological assessment, met the criteria to be admitted onto Baker 17 (the New York Presbyterian inpatient rehabilitation unit), and were administered standardized assessments or rating scales as part of routine standard care will be included in the database.

Exclusion Criteria:

Persons with stroke who could not be given standard assessments or rating scales (eg.

due to fatigue, decreased attention span, global aphasia or refusal) will not be included in data analysis.

Primary outcomes:
measure: Participation questionnaire - Boston University Activity Measure for Post-Acute Care (AM-PAC) - administered by research assistant
timeFrame: 6 months
measure: Participation questionnaire - Community Participation Indicators (CPI) - administered by research assistant
timeFrame: 6 months
measure: Participation questionnaire - Stroke Impact Scale (SIS) Participation domain - administered by research assistant
timeFrame: 6 months
measure: Participation questionnaire - Boston University Activity Measure for Post-Acute Care (AM-PAC) - administered by research assistant
timeFrame: 12 months
measure: Participation questionnaire - Community Participation Indicators (CPI) - administered by research assistant
timeFrame: 12 months
measure: Participation questionnaire - Stroke Impact Scale (SIS) Participation domain - administered by research assistant
timeFrame: 12 months
measure: Mobility - Trunk Control Test - administered by physical therapist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Mobility - Berg Balance Scale - administered by physical therapist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Mobility - Timed Up and Go (TUG) - administered by physical therapist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Mobility - Functional Reach Test - administered by physical therapist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Mobility - Postural Assessment Scale for Stroke (PASS) - administered by physical therapist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Mobility - 2 or 6 Minute Walk Test - administered by physical therapist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Mobility - 10 Meter Walk Test - administered by physical therapist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Mobility - Lower Extremity Motricity Index - administered by physical therapist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Upper extremity - Stroke Upper Limb Capacity Scale (SULCS) - administered by occupational therapist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Upper extremity - Upper Extremity Motricity Index - administered by occupational therapist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Functional domain - Functional Independence Measure (FIM) - administered by various members of rehabilitation team (physical therapy, occupational therapy, nursing, speech therapist)
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Functional domain - Boston University Activity Measure for Post-Acute Care (AM-PAC) - administered by research assistant
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Functional and cognitive domains - Executive Function Performance Test (EFPT) bill paying task - administered by occupational therapist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Secondary outcomes:
measure: Engagement in rehabilitation - Hopkins Rehabilitation Engagement Rating Scale (HRERS) - administered independently by occupational and physical therapists
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Cognition - Hopkins Verbal Learning Test-Revised (HVLT-R) - administered by speech therapist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Cognition - Trail Making Test (TMT) - administered by occupational therapist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Cognition - Montreal Cognitive Assessment (MoCA) - administered by occupational therapist
timeFrame: Admission (within 72 hours after admission into the inpatient rehabilitation unit - IRU)
measure: Cognition - Digit Span test - administered by neuropsychologist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Cognition - Stroop Color and Word test - administered by neuropsychologist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Cognition - Logical memory test - administered by neuropsychologist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Cognition - Brief visuospatial memory test - administered by neuropsychologist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
measure: Cognition - Dementia Rating Scale - administered by neuropsychologist
timeFrame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian/Weill Cornell Medical Center Rehabilitation Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Michael O'Dell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercy College
name: Joan Toglia, PhD
role: STUDY_DIRECTOR
References:
citation: Mastrogiovanni, A., Toglia, J., & O'Dell, M. Relationship between Instrumental Activities of Daily Living (IADL) and Cognition after Mild Acute Stroke. Archives of Physical Medicine and Rehabilitation, 95(10), e12, 2014.
citation: Martinez, A. J., Fitzgerald, K. A., Mastrogiovanni, A. R., O'Dell, M. W., & Toglia, J. Exploring the Relationship of the Visuoexecutive Subscore of the Montreal Cognitive Assessment and Trails B to Functional Outcomes in Patients With Stroke. PM&R, 3(10): S162, 2011.
citation: Frantz, M.A.; Woznica, D., Schwabe, E.; Villanueva, M., Toglia, J., O'Dell, M. AM-PAC correlates with measures of impairment at discharge from inpatient stroke rehabilitation. American Journal of Physical Medicine & Rehabilitation: 93(3): a1-a97, 2014.
citation: O'Dell, M., Toglia, J., & Taub, M. Predicting Participation Level Six Month Following Inpatient Stroke Rehabilitation. Archives of Physical Medicine and Rehabilitation 10(96): e56, 2015.
citation: Tufaro, D. C., Toglia, J., O'Dell, M., & Villanueva, M. Concurrent Validity of the Stroke Upper Limb Capacity Scale (SULCS). Archives of Physical Medicine and Rehabilitation 10(95): e17, 2014.
citation: Parfene, C., Toglia, J., Taub, M., & O'Dell, M. W. Differences in identifying memory impairment using the Montreal Cognitive Assessment and Hopkins Verbal Learning Test-Revised delayed recall scores in an acute stroke population. Clinical Neuropsychologist 30(3): 393-394, 2016.
citation: Toglia J, Askin G, Gerber LM, Taub MC, Mastrogiovanni AR, O'Dell MW. Association Between 2 Measures of Cognitive Instrumental Activities of Daily Living and Their Relation to the Montreal Cognitive Assessment in Persons With Stroke. Arch Phys Med Rehabil. 2017 Nov;98(11):2280-2287. doi: 10.1016/j.apmr.2017.04.007. Epub 2017 May 4.
citation: Taub, M., O'Dell, M., & Toglia, J. (2016). Relationship of Hopkins Rehabilitation Engagement Rating Scale to Baseline Cognition and FIM Change in Acute Inpatient Stroke Rehabilitation. Archives of Physical Medicine and Rehabilitation, 97(10), e111-e112.
citation: Meyer, A., Batistick, H., Toglia, J., Taub, M., & O'Dell, M. (2016). Factors Associated with a Large Time Differential Between Timed Up and Go and Gait Speed During Inpatient Stroke Rehabilitation. Archives of Physical Medicine and Rehabilitation, 97(10), e70-e71.
citation: Lowder RJ, Jaywant A, Fridman CB, Toglia J, O'Dell MW. Cognitive impairment predicts engagement in inpatient stroke rehabilitation. Int J Rehabil Res. 2022 Dec 1;45(4):359-365. doi: 10.1097/MRR.0000000000000552. Epub 2022 Oct 17.
citation: O'Dell MW, Jaywant A, Frantz M, Patel R, Kwong E, Wen K, Taub M, Campo M, Toglia J. Changes in the Activity Measure for Post-Acute Care Domains in Persons With Stroke During the First Year After Discharge From Inpatient Rehabilitation. Arch Phys Med Rehabil. 2021 Apr;102(4):645-655. doi: 10.1016/j.apmr.2020.11.020. Epub 2021 Jan 10.
citation: Campo M, Toglia J, Batistick-Aufox H, O'Dell MW. Standardized Outcome Measures in Stroke Rehabilitation and Falls After Discharge: A Cohort Study. PM R. 2021 Mar;13(3):265-273. doi: 10.1002/pmrj.12396. Epub 2020 Jun 10.
citation: Jaywant A, Toglia J, Gunning FM, O'Dell MW. Subgroups Defined by the Montreal Cognitive Assessment Differ in Functional Gain During Acute Inpatient Stroke Rehabilitation. Arch Phys Med Rehabil. 2020 Feb;101(2):220-226. doi: 10.1016/j.apmr.2019.08.474. Epub 2019 Sep 10.