NCT02235974

Critical Periods After Stroke Study (CPASS)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: MedStar National Rehabilitation Network · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	Control	Usual and Customary Care only. No additional therapy will be given during the 1-year study.

Timeline

• Start date: 2014-08-26
• Primary completion: 2020-12-31
• Completion: 2021-01-31
• First posted: 2014-09-10
• Last updated: 2020-04-07

Locations

1 site across 1 country: United States