Overview

This trial is active, not recruiting.

Condition stroke
Treatment observational - no intervention
Sponsor Weill Medical College of Cornell University
Start date July 2012
End date June 2018
Trial size 273 participants
Trial identifier NCT02876783, 1112012072

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Participation questionnaire - Boston University Activity Measure for Post-Acute Care (AM-PAC) - administered by research assistant
time frame: 6 months
Participation questionnaire - Community Participation Indicators (CPI) - administered by research assistant
time frame: 6 months
Participation questionnaire - Stroke Impact Scale (SIS) Participation domain - administered by research assistant
time frame: 6 months
Participation questionnaire - Boston University Activity Measure for Post-Acute Care (AM-PAC) - administered by research assistant
time frame: 12 months
Participation questionnaire - Community Participation Indicators (CPI) - administered by research assistant
time frame: 12 months
Participation questionnaire - Stroke Impact Scale (SIS) Participation domain - administered by research assistant
time frame: 12 months
Mobility - Trunk Control Test - administered by physical therapist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Mobility - Berg Balance Scale - administered by physical therapist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Mobility - Timed Up and Go (TUG) - administered by physical therapist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Mobility - Functional Reach Test - administered by physical therapist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Mobility - Postural Assessment Scale for Stroke (PASS) - administered by physical therapist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Mobility - 2 or 6 Minute Walk Test - administered by physical therapist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Mobility - 10 Meter Walk Test - administered by physical therapist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Mobility - Lower Extremity Motricity Index - administered by physical therapist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Upper extremity - Stroke Upper Limb Capacity Scale (SULCS) - administered by occupational therapist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Upper extremity - Upper Extremity Motricity Index - administered by occupational therapist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Functional domain - Functional Independence Measure (FIM) - administered by various members of rehabilitation team (physical therapy, occupational therapy, nursing, speech therapist)
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Functional domain - Boston University Activity Measure for Post-Acute Care (AM-PAC) - administered by research assistant
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Functional and cognitive domains - Executive Function Performance Test (EFPT) bill paying task - administered by occupational therapist
time frame: 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
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Cognition - Hopkins Verbal Learning Test-Revised (HVLT-R) - administered by speech therapist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Cognition - Trail Making Test (TMT) - administered by occupational therapist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Cognition - Digit Span test - administered by neuropsychologist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Cognition - Stroop Color and Word test - administered by neuropsychologist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Cognition - Logical memory test - administered by neuropsychologist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Cognition - Brief visuospatial memory test - administered by neuropsychologist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)
Cognition - Dementia Rating Scale - administered by neuropsychologist
time frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

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.

Additional Information

Official title Analysis of Stroke Rehabilitation Outcomes
Principal investigator Michael O'Dell, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.