Arm Rehabilitation Study After Stroke

Summary

This study is about arm and hand recovery after a stroke. The investigators are testing an experimental arm therapy called Accelerated Skill Acquisition Program (ASAP) which combines challenging, intensive and meaningful practice of tasks of the participant's choice compared to two standard types of therapy (usual and customary arm therapy totaling 30 hours and usual and customary arm therapy for a duration indicated on the therapy prescription). A second objective is to characterize current outpatient arm therapy (dosage \& content) following stroke for individuals who are eligible for ICARE. Eligible candidates must have had a stroke affecting an arm within the last 106 days.

Conditions

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

Interventions

BEHAVIORAL

Accelerated Skill Acquisition Program (ASAP)

A 30-hour dose is administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session precedes the first visit.

BEHAVIORAL

Dose-Equivalent Usual & Customary Care - DEUCC

Usual and customary arm therapy administered early post-acutely in the outpatient setting, adjusted for dose, but otherwise administered in accordance with usual and customary practices. This is a 30-hour dose equivalency group, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.

BEHAVIORAL

Usual and Customary Care - UCC

Usual and customary arm therapy administered early post-acutely in the outpatient setting. This is an observation only group and treatment dose will be administered in accordance with usual and customary practices.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of Southern California

  lead OTHER

Principal Investigators

• Carolee J. Winstein, PhD, PT · University of Southern California

• Alexander Dromerick, MD · MedStar National Rehabilitation Network

• Steven Wolf, PhD, PT · Emory University

• Monica A Nelsen, DPT, PT · University of Southern California

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2014-02-28

Completion

2014-02-28

Countries

• United States

Study Locations