Critical Periods After Stroke Study (CPASS)
- Conditions
- StrokeBrain InfarctionCerebral InfarctionCerebrovascular DisordersBrain Ischemia
- Interventions
- Behavioral: Early Intensive upper extremity motor trainingBehavioral: Sub-acute intensive upper extremity motor trainingBehavioral: Chronic intensive upper extremity motor trainingBehavioral: Control
- Registration Number
- NCT02235974
- Lead Sponsor
- MedStar National Rehabilitation Network
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
-
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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acute/Early Early Intensive upper extremity motor training Intervention: A 20-hour dose of early intensive upper extremity motor training therapy will be initiated within 30 days post-stroke. Sub-acute/Outpatient Sub-acute intensive upper extremity motor training Intervention: A 20-hour dose of sub-acute intensive upper extremity motor training therapy will be initiated within 2 to 3 months post-stroke. Chronic Chronic intensive upper extremity motor training Intervention: A 20-hour dose of chronic intensive upper extremity motor training therapy will be initiated 6 to 9 months post-stroke Control Control Intervention: Usual and customary care. No additional therapy will be initiated during the 1-year study.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Manual Muscle Test (Upper Extremity) Baseline (within 30 days post stroke) Muscle strength assessment
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.
Trial Locations
- Locations (1)
MedStar National Rehabilitation Hospital
🇺🇸Washington, District of Columbia, United States