Critical Periods After Stroke Study (CPASS)

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Georgetown University

  collaborator OTHER

• University of Wisconsin, Madison

  collaborator OTHER

• The Catholic University of America

  collaborator OTHER

• Medstar Health Research Institute

  collaborator OTHER

• MedStar National Rehabilitation Network

  lead OTHER

Principal Investigators

• Alexander W Dromerick, MD · MedStar National Rehabilitation Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-08-26

Primary Completion

2020-12-31

Completion

2021-01-31

Countries

• United States

Study Locations