Critical Periods After Stroke Study (CPASS)

NCT ID: NCT02235974

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-26
• Study Completion Date: 2021-01-31

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.

Conditions

Stroke; Brain Infarction; Brain Ischemia; Cerebral Infarction; Cerebrovascular Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acute/Early

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

Group Type: EXPERIMENTAL

Early Intensive upper extremity motor training

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Sub-acute intensive upper extremity motor training

Intervention Type: BEHAVIORAL

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.

Chronic

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

Group Type: EXPERIMENTAL

Chronic intensive upper extremity motor training

Intervention Type: BEHAVIORAL

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.

Control

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

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Usual and Customary Care only. No additional therapy will be given during the 1-year study.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Control

Usual and Customary Care only. No additional therapy will be given during the 1-year study.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Georgetown University

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: collaborator

The Catholic University of America

OTHER

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: collaborator

MedStar National Rehabilitation Network

OTHER

Sponsor Role: lead

Responsible Party

Alexander W. Dromerick, MD

Vice President for Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander W Dromerick, MD

Role: PRINCIPAL_INVESTIGATOR

MedStar National Rehabilitation Network

Locations

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25972803 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34168611 (View on PubMed)

Other Identifiers

MNRH-2014-065

Identifier Type: -

Identifier Source: org_study_id