Critical Periods After Stroke Study (CPASS)

Stroke Clinical Trial

— CPASS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02235974
• Other study ID #: MNRH-2014-065
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 26, 2014
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2020
• Source: MedStar National Rehabilitation Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain Infarction
• Brain Ischemia
• Cerebral Infarction
• Cerebrovascular Disorders
• Infarction
• Ischemia
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	MedStar National Rehabilitation Hospital	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
MedStar National Rehabilitation Network	Georgetown University, Medstar Health Research Institute, The Catholic University of America, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Motor Assessment Scale - Upper Arm Function (MAS)	Performance-based scale to assess everyday motor function.	Baseline (within 30 days of stroke onset)
Primary	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	Motor Activity Log - 28 Quality of Movement (MAL-28 QOM)	A structured interview to measure upper extremity use and function as well as assess the quality of movement of the hemiparetic arm.	Pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Secondary	Nine Hole Peg Test (9-HPT)	A standardized quantitative test of upper extremity function and fine manual dexterity.	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	Functional Independence Measure (FIM)	A basic indicator of severity of disability. Tracks changes in the functional ability of the patient during an episode of hospital rehabilitation care.	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	Barthel Index (BI)	Measures performance in activities of daily living and functional disability.	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	Motricity Index - Arm only (MI)	To assess motor impairment and strength in 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	Perception of change (POC)	A stroke-specific self-report to assess how stroke has impacted a person's life and their overall perception of recovery.	Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
Secondary	Stroke Impact Scale - Hand-Arm subscale (SIS)	A self-report health status measure to assess perceived recovery with regard to the more affected hand and arm following a stroke.	Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
Secondary	Modified Rankin Scale (MRS)	A measure of the degree of disability or dependence in daily activities following a stroke.	Baseline (pre-stroke assessment), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
Secondary	Activity Card Sort (ACS)	An interview-based assessment used to measure an individual's participation in instrumental, leisure and social activities.	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
Secondary	Reintegration to Normal Living Index (RNLI)	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.	Post-treatment (within 72 hours after treatment has ended), 6 months and 1 year post stroke
Secondary	Geriatric Depression Scale (GDS-15)	A self-report assessment used to identify depressive symptoms in the elderly.	Baseline (within 30 days post stroke), pre-treatment, and 1 year post stroke
Secondary	NIH Stroke Scale (NIHSS)	A systematic assessment used to evaluate and measure stroke-related. neurological impairments and stroke severity.	Baseline (within 30 days post stroke), pre-treatment, 6 months and 1 year post stroke
Secondary	Short Blessed Orientation and Memory Concentration Test (SBT)	An assessment of cognitive ability and impairment.	Baseline (within 30 days post stroke)
Secondary	Mesulam Symbol Cancellation Test (SCT)	An assessment used to evaluate visuospatial function and attention.	Baseline (within 30 days post stroke)
Secondary	Faces Pain Scale	A self-report measure of pain intensity.	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	Fugl Meyer Assessment (Upper Extremity)	A performanced-based impairment index to assess motor function, sensation and joint function.	Baseline (within 30 days post stroke) and 1 year post stroke
Secondary	Manual Muscle Test (Upper Extremity)	Muscle strength assessment	Baseline (within 30 days post stroke)