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Trial record 1 of 4 for:    CPASS
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Critical Periods After Stroke Study (CPASS) (CPASS)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Alexander W. Dromerick, MD, MedStar National Rehabilitation Network
Sponsor:
Collaborators:
Georgetown University
University of Wisconsin, Madison
The Catholic University of America
Medstar Health Research Institute
Information provided by (Responsible Party):
Alexander W. Dromerick, MD, MedStar National Rehabilitation Network
ClinicalTrials.gov Identifier:
NCT02235974
First received: July 14, 2014
Last updated: May 19, 2017
Last verified: May 2017
  Purpose

To perform an exploratory single center randomized study that will form the basis for a larger scale, more definitive randomized clinical trial to determine the optimal time after stroke for intensive motor training. The investigators will perform a prospective exploratory study of upper extremity (UE) motor training delivered at higher than usual intensity at three different time points after stroke:

  • early (initiated within 30 days)
  • subacute/outpatient (initiated within 2-3 months)
  • chronic (initiated within 6-9 months)

The control group will not receive the therapy intervention during the 1-year study.

Outcome measures will be assessed at baseline, pre-treatment, post-treatment, 6 months and one year after stroke onset.

Compared to individuals randomized during the outpatient (2-3 months after stroke onset) or chronic (6-9 months after stroke onset) time points, participants randomized to early intensive motor training will show greater upper extremity motor improvement measured at one year post stroke.


Condition Intervention
Stroke Brain Infarction Brain Ischemia Cerebral Infarction Cerebrovascular Disorders Behavioral: Early Intensive upper extremity motor training Behavioral: Sub-acute intensive upper extremity motor training Behavioral: Chronic intensive upper extremity motor training Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Critical Periods After Stroke Study (CPASS); Sensitive Periods and Consumer Preferences: Optimizing Upper Extremity Stroke Rehabilitation

Resource links provided by NLM:


Further study details as provided by Alexander W. Dromerick, MD, MedStar National Rehabilitation Network:

Primary Outcome Measures:
  • Action Research Arm Test (ARAT) [ Time Frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke ]
    The ARAT assesses functional limitations and evaluates changes in limb function for the upper extremity.


Secondary Outcome Measures:
  • Motor Activity Log - 28 Quality of Movement (MAL-28 QOM) [ Time Frame: Pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke ]
    A structured interview to measure upper extremity use and function as well as assess the quality of movement of the hemiparetic arm.

  • Nine Hole Peg Test (9-HPT) [ Time Frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke ]
    A standardized quantitative test of upper extremity function and fine manual dexterity.

  • Functional Independence Measure (FIM) [ Time Frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke ]
    A basic indicator of severity of disability. Tracks changes in the functional ability of the patient during an episode of hospital rehabilitation care.

  • Barthel Index (BI) [ Time Frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke ]
    Measures performance in activities of daily living and functional disability.

  • Motricity Index - Arm only (MI) [ Time Frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke ]
    To assess motor impairment and strength in the upper extremity.

  • Perception of change (POC) [ Time Frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke ]
    A stroke-specific self-report to assess how stroke has impacted a person's life and their overall perception of recovery.

  • Stroke Impact Scale - Hand-Arm subscale (SIS) [ Time Frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke ]
    A self-report health status measure to assess perceived recovery with regard to the more affected hand and arm following a stroke.

  • Modified Rankin Scale (MRS) [ Time Frame: Baseline (pre-stroke assessment), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke ]
    A measure of the degree of disability or dependence in daily activities following a stroke.

  • Activity Card Sort (ACS) [ Time Frame: Pre-treatment (ideally within 72 hours of baseline), post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke ]
    An interview-based assessment used to measure an individual's participation in instrumental, leisure and social activities.

  • Reintegration to Normal Living Index (RNLI) [ Time Frame: Post-treatment (within 72 hours after treatment has ended), 6 months and 1 year post stroke ]
    To assess quantitatively the degree that individuals who have experienced a traumatic injury or illness come to manage and reintegrate normal social activities with regard to recreation, movement at home and within the community, family and relationships.

  • Geriatric Depression Scale (GDS-15) [ Time Frame: Baseline (within 30 days post stroke), pre-treatment, and 1 year post stroke ]
    A self-report assessment used to identify depressive symptoms in the elderly.

  • NIH Stroke Scale (NIHSS) [ Time Frame: Baseline (within 30 days post stroke), pre-treatment, 6 months and 1 year post stroke ]
    A systematic assessment used to evaluate and measure stroke-related. neurological impairments and stroke severity.

  • Short Blessed Orientation and Memory Concentration Test (SBT) [ Time Frame: Baseline (within 30 days post stroke) ]
    An assessment of cognitive ability and impairment.

  • Mesulam Symbol Cancellation Test (SCT) [ Time Frame: Baseline (within 30 days post stroke) ]
    An assessment used to evaluate visuospatial function and attention.

  • Faces Pain Scale [ Time Frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke ]
    A self-report measure of pain intensity.

  • Fugl Meyer Assessment (Upper Extremity) [ Time Frame: Baseline (within 30 days post stroke) and 1 year post stroke ]
    A performanced-based impairment index to assess motor function, sensation and joint function.


Other Outcome Measures:
  • Motor Assessment Scale - Upper Arm Function (MAS) [ Time Frame: Baseline (within 30 days of stroke onset) ]
    Performance-based scale to assess everyday motor function.


Estimated Enrollment: 64
Study Start Date: July 2014
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acute/Early
Intervention: A 20-hour dose of early intensive upper extremity motor training therapy will be initiated within 30 days post-stroke.
Behavioral: Early Intensive upper extremity motor training
Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 30 days of stroke onset.
Experimental: Sub-acute/Outpatient
Intervention: A 20-hour dose of sub-acute intensive upper extremity motor training therapy will be initiated within 2 to 3 months post-stroke.
Behavioral: Sub-acute intensive upper extremity motor training
Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 2 to 3 months post stroke.
Experimental: Chronic
Intervention: A 20-hour dose of chronic intensive upper extremity motor training therapy will be initiated 6 to 9 months post-stroke
Behavioral: Chronic intensive upper extremity motor training
Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 6 to 9 months post stroke.
Placebo Comparator: Control
Intervention: Usual and customary care. No additional therapy will be initiated during the 1-year study.
Behavioral: Control
Usual and Customary Care only. No additional therapy will be given during the 1-year study.

Detailed Description:

Please see the following reference:

Dromerick, A.W., Edwardson, M., Edwards, D.F., Giannetti, M.L., Barth, J., Brady, K.P., Chan, E., Tan, M.T., Tamboli, I., Chia, R., Orquiza, M., Padilla, R.M., Cheema, A.K., Mapstone, M., Fiandaca, M.S., Federoff, H.J., & Newport, E.L. (2015). Critical Periods after Stroke Study: Translating animal stroke recovery experiments into a clinical trial. Frontiers in Human Neuroscience, 9, 002231. PMCID: PMC4413691.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke (with confirmatory neuroimaging) within 28 days of admission to inpatient rehabilitation (allows those randomized to the early arm to begin study-related treatment within 30 days)
  • Age >21 years
  • Able to participate in first study-related treatment session within 30 days of stroke onset
  • Able to participate in all study-related activities, including one year follow up and blood draws
  • Persistent hemiparesis leading to impaired upper extremity function. Hemiparesis as indicated by NIHSS Motor Arm score ≥ 1
  • Recovering moderate motor impairment at the shoulder and elbow or hand such as:

    • Proximal UE voluntary activity indicated by a score of ≥ 3 on the upper arm item of the Motor Assessment Scale - wrist and finger movement is not required or
    • Manual Muscle Test (MMT) score of ≥ 2 on shoulder flexion or abduction and MMT score of ≥ 2 for any of the following: elbow flexion, elbow extension, wrist flexion, wrist extension, finger flexion or finger extension.
  • Score of ≤ 8 on the Short Blessed Memory Orientation and Concentration Scale
  • Follows 2 step commands
  • No upper extremity injury or conditions that limited use prior to the stroke
  • Pre-stroke independence: Modified Rankin Score 0 or 1

Exclusion Criteria:

  • Inability to give informed consent
  • Prior stroke with persistent motor impairment or other disabling neurologic condition such as multiple sclerosis, parkinsonism, amyotrophic lateral sclerosis (ALS), dementia requiring medication
  • Rapidly improving motor function
  • Clinically significant fluctuations in mental status in the 72 hours prior to randomization
  • Hemispatial neglect as determined by >3 errors on the Mesulam Symbol Cancellation Test
  • Not independent prior to stroke (determined by scores of <95 on Barthel Index or >1 on Modified Rankin Scale
  • Dense sensory loss indicated by a score of 2 on NIHSS sensory item
  • Ataxia out of proportion to weakness in the affected arm as described by a score of ≥ 1 on the NIHSS limb ataxia item
  • Active or prior psychosis within 2 years
  • Active or prior (within 2 years) substance abuse
  • Not expected to survive 1 year due to other illnesses (cardiac disease, malignancy, etc)
  • Received upper extremity botulinum toxin within 6 months (other medications do not exclude)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02235974

Contacts
Contact: Margot G McCloskey, BA 202-877-1071 Margot.Giannetti@medstar.net
Contact: Jessica Barth, MS, OTR/L 202-877-1031 Jessica.Barth@medstar.net

Locations
United States, District of Columbia
MedStar National Rehabilitation Hospital Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Alexander W Dromerick, MD    202-877-1946    Alexander.W.Dromerick@medstar.net   
Contact: Margot G McCloskey, BA    202-877-1071    Margot.Giannetti@medstar.net   
Principal Investigator: Alexander W Dromerick, MD         
Sponsors and Collaborators
MedStar National Rehabilitation Network
Georgetown University
University of Wisconsin, Madison
The Catholic University of America
Medstar Health Research Institute
Investigators
Principal Investigator: Alexander W Dromerick, MD MedStar National Rehabilitation Network
  More Information

Publications:
Responsible Party: Alexander W. Dromerick, MD, Vice President for Research, MedStar National Rehabilitation Network
ClinicalTrials.gov Identifier: NCT02235974     History of Changes
Other Study ID Numbers: MNRH-2014-065
Study First Received: July 14, 2014
Last Updated: May 19, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There is no plan at this time to make individual participant data available.

Keywords provided by Alexander W. Dromerick, MD, MedStar National Rehabilitation Network:
stroke
critical periods
sensitive periods
hemiparesis
upper extremity
physical rehabilitation
arm therapy
occupational therapy
physical therapy
task oriented training
patient focused
arm function
hand function
neurorehabilitation
motor learning
motor control
motor function
motor recovery
skill acquisition
skill training

Additional relevant MeSH terms:
Stroke
Infarction
Ischemia
Cerebral Infarction
Brain Infarction
Cerebrovascular Disorders
Brain Ischemia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on June 26, 2017