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Clinical Trials/NCT02876783
NCT02876783
Completed
Not Applicable

Analysis of Stroke Rehabilitation Outcomes

Weill Medical College of Cornell University1 site in 1 country273 target enrollmentJuly 25, 2012
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Weill Medical College of Cornell University
Enrollment
273
Locations
1
Primary Endpoint
Mobility - Lower Extremity Motricity Index - administered by physical therapist
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 25, 2012
End Date
January 3, 2017
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Mobility - Lower Extremity Motricity Index - administered by physical therapist

Time Frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)

Lower Extremity Motricity Index - Measures muscle strength of paretic side, post-stroke. Includes three items: ankle dorsiflexion, knee extension, hip flexion. Total score range 0-100

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)

A questionnaire that examines a set of functional activities that are likely to be encountered by most adults during daily routines within the context of either an inpatient episode of care or outpatient post acute services. AM-PAC item banks are organized into three functional areas: Basic Mobility (101 items), Daily Activity (70 items), and Applied Cognitive (69 items).

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)

Measures upper limb capability in post-stroke patients. It includes basic upper limb capacity items (requiring little to no hand function) and advanced upper limb capacity items (necessitates moderate to good hand function). Includes 10 items related to daily activities of patient in the home environment; three items that test proximal upper limb (arm) capacity without the need for active wrist and finger movements; four items that test for upper limb capacity requiring basic control of wrist and finger movements; three items for upper limb capacity requiring advanced control of wrist and finger movements

Upper extremity - Upper Extremity Motricity Index - administered by occupational therapist

Time Frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)

Measures muscle strength of the paretic side of patient who has had a stroke. It includes three items: pinch grip, elbow flexion, shoulder abduction. Total scores range 0-100

Participation questionnaire - Boston University Activity Measure for Post-Acute Care (AM-PAC) - administered by research assistant

Time Frame: 12 months

Boston University Activity Measure for Post-Acute Care (AM-PAC) - A questionnaire that examines a set of functional activities that are likely to be encountered by most adults during daily routines within the context of either an inpatient episode of care or outpatient post acute services. AM-PAC item banks are organized into three functional areas: Basic Mobility (101 items), Daily Activity (70 items), and Applied Cognitive (69 items).

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)

An instrumental activities of daily living assessment (IADL) that tests the patient's ability to use five executive functions of a task: (1) initiation of a task, (2) organization, (3) sequencing, (4) safety and judgment, and (5) completion.

Participation questionnaire - Community Participation Indicators (CPI) - administered by research assistant

Time Frame: 12 months

Community Participation Indicators (CPI) - Part 1 has the patient rate the frequency at which he/she does various activities, and asks if the activity is important to the patient. Part 2 has the patient rate how frequently their behavior aligns with various prompts, for example "I live my life the way that I want".

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)

A 12 item scale used for assessing postural control following stroke.

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)

Assesses patient's walking distance

Mobility - 10 Meter Walk Test - administered by physical therapist

Time Frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)

Assesses patient's walking speed

Mobility - Timed Up and Go (TUG) - administered by physical therapist

Time Frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)

Assesses mobility, balance, walking ability and fall risk. Measured in seconds.

Mobility - Functional Reach Test - administered by physical therapist

Time Frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)

Measures maximum distance an individual can reach forward while standing in a fixed position.

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)

A uniform system of measurement for disability. It measures the level of a patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living.

Participation questionnaire - Stroke Impact Scale (SIS) Participation domain - administered by research assistant

Time Frame: 12 months

Stroke Impact Scale (SIS) Participation domain - A stroke-specific, self-reported, health status measure separated into 8 domains. We only administer the Participation domain.

Mobility - Trunk Control Test - administered by physical therapist

Time Frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)

Includes four items: rolling to weak side, rolling to strong side, sitting up from lying down, balance in sitting position. Total score range 0-100

Mobility - Berg Balance Scale - administered by physical therapist

Time Frame: Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU)

Measures balance in patients by assessing performance of functional tasks. Total score range 0 (lowest level) to 56 (highest level)

Secondary Outcomes

  • Cognition - Hopkins Verbal Learning Test-Revised (HVLT-R) - administered by speech therapist(Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU))
  • Cognition - Brief visuospatial memory test - administered by neuropsychologist(Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU))
  • Engagement in rehabilitation - Hopkins Rehabilitation Engagement Rating Scale (HRERS) - administered independently by occupational and physical therapists(Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU))
  • Cognition - Stroop Color and Word test - administered by neuropsychologist(Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU))
  • Cognition - Trail Making Test (TMT) - administered by occupational therapist(Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU))
  • Cognition - Montreal Cognitive Assessment (MoCA) - administered by occupational therapist(Admission (within 72 hours after admission into the inpatient rehabilitation unit - IRU))
  • Cognition - Digit Span test - administered by neuropsychologist(Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU))
  • Cognition - Logical memory test - administered by neuropsychologist(Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU))
  • Cognition - Dementia Rating Scale - administered by neuropsychologist(Discharge (within 72 hours prior to discharge from inpatient rehabilitation unit - IRU))

Study Sites (1)

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