Clinical trial NCT02235974: Critical Periods After Stroke Study (CPASS)
Official title: Critical Periods After Stroke Study (CPASS); Sensitive Periods and Consumer Preferences: Optimizing Upper Extremity Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: MedStar National Rehabilitation Network
Sponsor class: OTHER
Collaborators: name: Georgetown University
name: University of Wisconsin, Madison
name: The Catholic University of America
name: Medstar Health Research Institute
First posted: 2014-09-10
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: 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:
measure: Motor Activity Log - 28 Quality of Movement (MAL-28 QOM)
timeFrame: Pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
measure: Nine Hole Peg Test (9-HPT)
timeFrame: 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
measure: Functional Independence Measure (FIM)
timeFrame: 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
measure: Barthel Index (BI)
timeFrame: 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
measure: Motricity Index - Arm only (MI)
timeFrame: 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
measure: Perception of change (POC)
timeFrame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
measure: Stroke Impact Scale - Hand-Arm subscale (SIS)
timeFrame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
measure: Modified Rankin Scale (MRS)
timeFrame: Baseline (pre-stroke assessment), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
measure: Activity Card Sort (ACS)
timeFrame: 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
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: Post-treatment (within 72 hours after treatment has ended), 6 months and 1 year post stroke
measure: Geriatric Depression Scale (GDS-15)
timeFrame: Baseline (within 30 days post stroke), pre-treatment, and 1 year post stroke
measure: NIH Stroke Scale (NIHSS)
timeFrame: Baseline (within 30 days post stroke), pre-treatment, 6 months and 1 year post stroke
measure: Short Blessed Orientation and Memory Concentration Test (SBT)
timeFrame: Baseline (within 30 days post stroke)
measure: Mesulam Symbol Cancellation Test (SCT)
timeFrame: Baseline (within 30 days post stroke)
measure: Faces Pain Scale
timeFrame: 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
measure: Fugl Meyer Assessment (Upper Extremity)
timeFrame: Baseline (within 30 days post stroke) and 1 year post stroke
measure: Manual Muscle Test (Upper Extremity)
timeFrame: Baseline (within 30 days post stroke)
Other outcomes:
measure: Motor Assessment Scale - Upper Arm Function (MAS)
timeFrame: Baseline (within 30 days of stroke onset)
Locations:
city: Washington
country: United States
facility: MedStar National Rehabilitation Hospital
state: District of Columbia
Study officials:
affiliation: MedStar National Rehabilitation Network
name: Alexander W Dromerick, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.