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Critical Periods After Stroke Study (CPASS) (CPASS)

Primary Purpose

Stroke, Brain Infarction, Brain Ischemia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Intensive upper extremity motor training
Sub-acute intensive upper extremity motor training
Chronic intensive upper extremity motor training
Control
Sponsored by
MedStar National Rehabilitation Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring 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

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

or

  • Active range of motion (AROM) to at least 50% of range in gravity eliminated position for shoulder flexion or abduction, and for any of the following motions: 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)

Sites / Locations

  • MedStar National Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Acute/Early

Sub-acute/Outpatient

Chronic

Control

Arm Description

Intervention: A 20-hour dose of early intensive upper extremity motor training therapy will be initiated within 30 days post-stroke.

Intervention: A 20-hour dose of sub-acute intensive upper extremity motor training therapy will be initiated within 2 to 3 months post-stroke.

Intervention: A 20-hour dose of chronic intensive upper extremity motor training therapy will be initiated 6 to 9 months post-stroke

Intervention: Usual and customary care. No additional therapy will be initiated during the 1-year study.

Outcomes

Primary Outcome Measures

Action Research Arm Test (ARAT)
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)
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)
A standardized quantitative test of upper extremity function and fine manual dexterity.
Functional Independence Measure (FIM)
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)
Measures performance in activities of daily living and functional disability.
Motricity Index - Arm only (MI)
To assess motor impairment and strength in the upper extremity.
Perception of change (POC)
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)
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)
A measure of the degree of disability or dependence in daily activities following a stroke.
Activity Card Sort (ACS)
An interview-based assessment used to measure an individual's participation in instrumental, leisure and social activities.
Reintegration to Normal Living Index (RNLI)
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)
A self-report assessment used to identify depressive symptoms in the elderly.
NIH Stroke Scale (NIHSS)
A systematic assessment used to evaluate and measure stroke-related. neurological impairments and stroke severity.
Short Blessed Orientation and Memory Concentration Test (SBT)
An assessment of cognitive ability and impairment.
Mesulam Symbol Cancellation Test (SCT)
An assessment used to evaluate visuospatial function and attention.
Faces Pain Scale
A self-report measure of pain intensity.
Fugl Meyer Assessment (Upper Extremity)
A performanced-based impairment index to assess motor function, sensation and joint function.
Manual Muscle Test (Upper Extremity)
Muscle strength assessment

Full Information

First Posted
July 14, 2014
Last Updated
April 6, 2020
Sponsor
MedStar National Rehabilitation Network
Collaborators
Georgetown University, University of Wisconsin, Madison, The Catholic University of America, Medstar Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02235974
Brief Title
Critical Periods After Stroke Study (CPASS)
Acronym
CPASS
Official Title
Critical Periods After Stroke Study (CPASS); Sensitive Periods and Consumer Preferences: Optimizing Upper Extremity Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 26, 2014 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
January 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MedStar National Rehabilitation Network
Collaborators
Georgetown University, University of Wisconsin, Madison, The Catholic University of America, Medstar Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Brain Infarction, Brain Ischemia, Cerebral Infarction, Cerebrovascular Disorders
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acute/Early
Arm Type
Experimental
Arm Description
Intervention: A 20-hour dose of early intensive upper extremity motor training therapy will be initiated within 30 days post-stroke.
Arm Title
Sub-acute/Outpatient
Arm Type
Experimental
Arm Description
Intervention: A 20-hour dose of sub-acute intensive upper extremity motor training therapy will be initiated within 2 to 3 months post-stroke.
Arm Title
Chronic
Arm Type
Experimental
Arm Description
Intervention: A 20-hour dose of chronic intensive upper extremity motor training therapy will be initiated 6 to 9 months post-stroke
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Intervention: Usual and customary care. No additional therapy will be initiated during the 1-year study.
Intervention Type
Behavioral
Intervention Name(s)
Early Intensive upper extremity motor training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sub-acute intensive upper extremity motor training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Chronic intensive upper extremity motor training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Usual and Customary Care only. No additional therapy will be given during the 1-year study.
Primary Outcome Measure Information:
Title
Action Research Arm Test (ARAT)
Description
The ARAT assesses functional limitations and evaluates changes in limb function for the upper extremity.
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
Secondary Outcome Measure Information:
Title
Motor Activity Log - 28 Quality of Movement (MAL-28 QOM)
Description
A structured interview to measure upper extremity use and function as well as assess the quality of movement of the hemiparetic arm.
Time Frame
Pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Title
Nine Hole Peg Test (9-HPT)
Description
A standardized quantitative test of upper extremity function and fine manual dexterity.
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
Title
Functional Independence Measure (FIM)
Description
A basic indicator of severity of disability. Tracks changes in the functional ability of the patient during an episode of hospital rehabilitation care.
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
Title
Barthel Index (BI)
Description
Measures performance in activities of daily living and functional disability.
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
Title
Motricity Index - Arm only (MI)
Description
To assess motor impairment and strength in the upper extremity.
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
Title
Perception of change (POC)
Description
A stroke-specific self-report to assess how stroke has impacted a person's life and their overall perception of recovery.
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
Title
Stroke Impact Scale - Hand-Arm subscale (SIS)
Description
A self-report health status measure to assess perceived recovery with regard to the more affected hand and arm following a stroke.
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
Title
Modified Rankin Scale (MRS)
Description
A measure of the degree of disability or dependence in daily activities following a stroke.
Time Frame
Baseline (pre-stroke assessment), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
Title
Activity Card Sort (ACS)
Description
An interview-based assessment used to measure an individual's participation in instrumental, leisure and social activities.
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
Title
Reintegration to Normal Living Index (RNLI)
Description
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.
Time Frame
Post-treatment (within 72 hours after treatment has ended), 6 months and 1 year post stroke
Title
Geriatric Depression Scale (GDS-15)
Description
A self-report assessment used to identify depressive symptoms in the elderly.
Time Frame
Baseline (within 30 days post stroke), pre-treatment, and 1 year post stroke
Title
NIH Stroke Scale (NIHSS)
Description
A systematic assessment used to evaluate and measure stroke-related. neurological impairments and stroke severity.
Time Frame
Baseline (within 30 days post stroke), pre-treatment, 6 months and 1 year post stroke
Title
Short Blessed Orientation and Memory Concentration Test (SBT)
Description
An assessment of cognitive ability and impairment.
Time Frame
Baseline (within 30 days post stroke)
Title
Mesulam Symbol Cancellation Test (SCT)
Description
An assessment used to evaluate visuospatial function and attention.
Time Frame
Baseline (within 30 days post stroke)
Title
Faces Pain Scale
Description
A self-report measure of pain intensity.
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
Title
Fugl Meyer Assessment (Upper Extremity)
Description
A performanced-based impairment index to assess motor function, sensation and joint function.
Time Frame
Baseline (within 30 days post stroke) and 1 year post stroke
Title
Manual Muscle Test (Upper Extremity)
Description
Muscle strength assessment
Time Frame
Baseline (within 30 days post stroke)
Other Pre-specified Outcome Measures:
Title
Motor Assessment Scale - Upper Arm Function (MAS)
Description
Performance-based scale to assess everyday motor function.
Time Frame
Baseline (within 30 days of stroke onset)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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. or Active range of motion (AROM) to at least 50% of range in gravity eliminated position for shoulder flexion or abduction, and for any of the following motions: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander W Dromerick, MD
Organizational Affiliation
MedStar National Rehabilitation Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar National Rehabilitation Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan at this time to make individual participant data available.
Citations:
PubMed Identifier
25972803
Citation
Dromerick AW, Edwardson MA, Edwards DF, Giannetti ML, Barth J, Brady KP, Chan E, Tan MT, Tamboli I, Chia R, Orquiza M, Padilla RM, Cheema AK, Mapstone ME, Fiandaca MS, Federoff HJ, Newport EL. Critical periods after stroke study: translating animal stroke recovery experiments into a clinical trial. Front Hum Neurosci. 2015 Apr 29;9:231. doi: 10.3389/fnhum.2015.00231. eCollection 2015.
Results Reference
background
PubMed Identifier
34168611
Citation
Geed S, Feit P, Edwards DF, Dromerick AW. Why Are Stroke Rehabilitation Trial Recruitment Rates in Single Digits? Front Neurol. 2021 Jun 8;12:674237. doi: 10.3389/fneur.2021.674237. eCollection 2021.
Results Reference
derived

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Critical Periods After Stroke Study (CPASS)

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