Study to Enhance Motor Acute Recovery With Intensive Training After Stroke

Johns Hopkins University3 sites in 2 countries32 target enrollmentMay 2015

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: Johns Hopkins University
Enrollment: 32
Locations: 3
Primary Endpoint: Fugl-Meyer Upper Extremity (FM-UE)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Stroke often results in limitation of arm movements, from which many people do not fully recover. We believe that early and intensive therapy is important to enhance recovery of arm movements after stroke. We are doing this research study to see how much arm movements improve with intensive therapy in patients have had a stroke in the past 6 weeks.

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

April 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johns Hopkins University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age over 21 years
•Ischemic stroke confirmed by CT or MRI within the previous 6 weeks
•No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no motor symptoms is allowed)
•Residual unilateral arm weakness with Fugl-Meyer Upper Extremity (FM-UE) score 6-40 at time of enrollment.
•Ability to give informed consent and understand the tasks involved.

Exclusion Criteria

•Space-occupying hemorrhagic transformation or associated intracranial hemorrhage.
•Arm impairment that is too severe or too mild on day of baseline testing just prior to beginning of the study intervention.
•Recent botox injection to upper limb or planned botox injection over the course of the 7-month study duration.
•Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤
•History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease).
•Inability to sit in a chair and perform upper limb exercises for one hour at a time.
•Participation in another upper extremity rehabilitative therapy study during the study period.
•Terminal illness
•Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments.