Critical Periods After Stroke Study (CPASS)

Sponsor

MedStar National Rehabilitation Network (Other)

Overall Status

Unknown status

CT.gov ID

NCT02235974

Collaborator

Georgetown University (Other), University of Wisconsin, Madison (Other), The Catholic University of America (Other), Medstar Health Research Institute (Other)

150

Enrollment

Location

Arms

77.2

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Critical Periods After Stroke Study (CPASS); Sensitive Periods and Consumer Preferences: Optimizing Upper Extremity Stroke Rehabilitation

Actual Study Start Date :

Aug 26, 2014

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Jan 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Action Research Arm Test (ARAT) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [Baseline (within 30 days post stroke)]
An assessment of cognitive ability and impairment.
Mesulam Symbol Cancellation Test (SCT) [Baseline (within 30 days post stroke)]
An assessment used to evaluate visuospatial function and attention.
Faces Pain Scale [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) [Baseline (within 30 days post stroke) and 1 year post stroke]
A performanced-based impairment index to assess motor function, sensation and joint function.
Manual Muscle Test (Upper Extremity) [Baseline (within 30 days post stroke)]
Muscle strength assessment

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

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.

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)