Critical Periods After Stroke Study (CPASS)

NCT02235974 | Unknown

• 1 other identifier: MNRH-2014-065
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Action Research Arm Test (ARAT)

  The ARAT assesses functional limitations and evaluates changes in limb function for the upper extremity.

  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 Outcomes (17)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (1)

• Motor Assessment Scale - Upper Arm Function (MAS)

  Baseline (within 30 days of stroke onset)

Study Arms (4)

Acute/Early

EXPERIMENTAL

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

Sub-acute/Outpatient

EXPERIMENTAL

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

Chronic

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Behavioral: Control

Interventions

Early Intensive upper extremity motor training 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.

Acute/Early

Sub-acute intensive upper extremity motor training 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.

Sub-acute/Outpatient

Chronic intensive upper extremity motor training 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.

Chronic

Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• MedStar National Rehabilitation Network: lead
• Georgetown University: collaborator
• University of Wisconsin, Madison: collaborator
• The Catholic University of America: collaborator
• Medstar Health Research Institute: collaborator

Study Sites (1)

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (2)

• 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.

  PMID: 25972803 BACKGROUND

• 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.

  PMID: 34168611 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Alexander W Dromerick, MD

  MedStar National Rehabilitation Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President for Research

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: September 10, 2014
• Study Start: August 26, 2014
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)