Study to Enhance Motor Acute Recovery With Intensive Training After Stroke (SMARTS2)

August 8, 2018 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • University of Zurich
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • New York
      • New York, New York, United States, 10032
        • Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Space-occupying hemorrhagic transformation or associated intracranial hemorrhage.
  2. Arm impairment that is too severe or too mild on day of baseline testing just prior to beginning of the study intervention.
  3. Recent botox injection to upper limb or planned botox injection over the course of the 7-month study duration.
  4. Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20.
  5. 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).
  6. Inability to sit in a chair and perform upper limb exercises for one hour at a time.
  7. Participation in another upper extremity rehabilitative therapy study during the study period.
  8. Terminal illness
  9. Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Device-assisted therapy
30 hours of therapy with the ArmeoPower device, a commercially available device for arm rehabilitation
Behavioral: Device-assisted therapy
Active Comparator: Therapy-based occupational therapy
30 hours of conventional occupational therapy that emphasizes task-oriented training.
Behavioral: Therapy-based occupational therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Upper Extremity (FM-UE)
Time Frame: from baseline to day 3 post-training
Change in arm impairment, measured by FM-UE
from baseline to day 3 post-training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Upper Extremity (FM-UE)
Time Frame: from baseline to day 90 post-training
Change in arm impairment, measured by FM-UE
from baseline to day 90 post-training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

University of Zurich
Columbia University
James S McDonnell Foundation

Investigators

  • Principal Investigator: John W. Krakauer, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

November 8, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00047647

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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