Analysis of Stroke Rehabilitation Outcomes

NCT02876783 | Completed

• 1 other identifier: 1112012072
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (19)

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

  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).

  6 months

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

  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".

  6 months

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

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

  6 months

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

  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).

  12 months

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

  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".

  12 months

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

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

  12 months

• Mobility - Trunk Control Test - administered by physical therapist

  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

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

• Mobility - Berg Balance Scale - administered by physical therapist

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

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

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

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

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

• Mobility - Functional Reach Test - administered by physical therapist

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

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

• Mobility - Postural Assessment Scale for Stroke (PASS) - administered by physical therapist

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

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

• Mobility - 2 or 6 Minute Walk Test - administered by physical therapist

  Assesses patient's walking distance

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

• Mobility - 10 Meter Walk Test - administered by physical therapist

  Assesses patient's walking speed

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

• Mobility - Lower Extremity Motricity Index - administered by physical therapist

  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

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

• Upper extremity - Stroke Upper Limb Capacity Scale (SULCS) - administered by occupational therapist

  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

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

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

  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

  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)

  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.

  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

  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).

  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

  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.

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

Secondary Outcomes (9)

• 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 - Hopkins Verbal Learning Test-Revised (HVLT-R) - administered by speech therapist

  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)

Interventions

Observational - No intervention OTHER

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

New York Presbyterian/Weill Cornell Medical Center Rehabilitation Medicine

New York, New York, 10065, United States

Location

Related Publications (13)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28478128 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 36237146 DERIVED

• 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.

  PMID: 33440132 DERIVED

• 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.

  PMID: 32358887 DERIVED

• 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.

  PMID: 31518565 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michael O'Dell, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Joan Toglia, PhD

  Mercy College

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 24, 2016
• Study Start: July 25, 2012
• Primary Completion: January 3, 2017
• Study Completion: January 3, 2017
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)