Critical Periods After Stroke Study (CPASS) "CPASS"

Recruiting

Phase N/A Results N/A

Trial Description

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

Interventions

  • Control Device
    Intervention Desc: Usual and Customary Care only. No additional therapy will be given during the 1-year study.
    ARM 1: Kind: Experimental
    Label: Control
    Description: Intervention: Usual and customary care. No additional therapy will be initiated during the 1-year study.
  • Early Intensive upper extremity motor training Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Acute/Early
    Description: A 20-hour dose of intensive upper extremity motor training therapy will be given within 30 days post-stroke.
  • Sub-acute intensive upper extremity motor training Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Sub-acute/Outpatient
    Description: A 20-hour dose of intensive upper extremity motor training therapy will be given within 2 to 3 months post-stroke.
  • Chronic intensive upper extremity motor training Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Chronic
    Description: A 20-hour dose of intensive upper extremity motor training therapy will be given 6 to 9 months post-stroke.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Action Research Arm Test (ARAT) Baseline (within 30 days post stroke), pre-treatment (within 72 hours of baseline), post-treatment (within 72 hours after treatment), 1 year post stroke No
Secondary Motor Activity Log - 28 Quality of Movement (MAL-28 QOM) Baseline (within 30 days post stroke), pre-treatment (within 72 hours of baseline), post-treatment (within 72 hours after treatment), 1 year post stroke No
Secondary Nine Hole Peg Test (9-HPT) Baseline (within 30 days post stroke), pre-treatment (within 72 hours of baseline), post-treatment (within 72 hours after treatment), 1 year post stroke No
Secondary Functional Independence Measure (FIM) Baseline (within 30 days post stroke), pre-treatment (within 72 hours of baseline), post-treatment (within 72 hours after treatment), 1 year post stroke No
Secondary Motor Assessment Scale - Upper Arm Function (MAS) Baseline (within 30 days of stroke onset) No
Secondary Barthel Index (BI) Baseline (within 30 days post stroke), pre-treatment (within 72 hours of baseline), post-treatment (within 72 hours after treatment), 1 year post stroke No
Secondary Motricity Index - Arm only (MI) Baseline (within 30 days post stroke), pre-treatment (within 72 hours of baseline), post-treatment (within 72 hours after treatment), 1 year post stroke No
Secondary Stroke Impact Scale - perceptions of change (SIS-POC) Baseline (within 30 days post stroke), pre-treatment (within 72 hours of baseline), post-treatment (within 72 hours after treatment), 1 year post stroke No
Secondary Stroke Impact Scale - Hand-Arm subscale (SIS) Baseline (within 30 days post stroke), pre-treatment (within 72 hours of baseline), post-treatment (within 72 hours after treatment), 1 year post stroke No
Secondary Modified Rankin Scale (MRS) Baseline (pre-stroke assessment), pre-treatment (within 72 hours of baseline), post-treatment (within 72 hours after treatment), 1 year post stroke No
Secondary Activity Card Sort (ACS) Pre-treatment (within 72 hours of baseline), post-treatment (within 72 hours after treatment), 1 year post stroke No
Secondary Reintegration to Normal Living Index (RNLI) Post-treatment (within 72 hours after treatment) and 1 year post stroke No
Secondary Geriatric Depression Scale (GDS-15) Baseline (within 30 days post stroke), pre-treatment (within 72 hours of baseline) and 1 year post stroke No
Secondary NIH Stroke Scale (NIHSS) Baseline (within 30 days post stroke), pre-treatment (within 72 hours of baseline), post-treatment (within 72 hours after treatment), 1 year post stroke No
Secondary Short Blessed Orientation and Memory Concentration Test (SBT) Baseline (within 30 days post stroke) No
Secondary Mesulam Symbol Cancellation Test (SCT) Baseline (within 30 days post stroke), pre-treatment (within 72 hours of baseline), post-treatment (within 72 hours after treatment), 1 year post stroke No
Secondary Faces Pain Scale Baseline (within 30 days post stroke), pre-treatment (within 72 hours of baseline), post-treatment (within 72 hours after treatment), 1 year post stroke No
Secondary 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 No
Secondary Fugl Meyer Assessment (Upper Extremity) Baseline (within 30 days post stroke) and 1 year post stroke No

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