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

This study is currently recruiting participants.
Verified September 2016 by John W. Krakauer, Johns Hopkins University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02292251
First Posted: November 17, 2014
Last Update Posted: September 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Columbia University
University of Zurich
James S McDonnell Foundation
Information provided by (Responsible Party):
John W. Krakauer, Johns Hopkins University
  Purpose
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.

Condition Intervention
Stroke Behavioral: Device-assisted therapy Behavioral: Therapy-based occupational therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study to Enhance Motor Acute Recovery With Intensive Training After Stroke

Further study details as provided by John W. Krakauer, Johns Hopkins University:

Primary Outcome Measures:
  • Fugl-Meyer Upper Extremity (FM-UE) [ Time Frame: from baseline to day 3 post-training ]
    Change in arm impairment, measured by FM-UE


Secondary Outcome Measures:
  • Fugl-Meyer Upper Extremity (FM-UE) [ Time Frame: from baseline to day 90 post-training ]
    Change in arm impairment, measured by FM-UE


Estimated Enrollment: 48
Study Start Date: May 2015
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02292251


Contacts
Contact: John Krakauer, MD 410-955-9320 jkrakau1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Susan Rice    410-614-3460    smrice@jhmi.edu   
Contact: Juan C Cortes, MD    410-955-9319    juancamilo@jhu.edu   
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Tomoko Kitago, MD    212-305-0737    tk2229@columbia.edu   
Switzerland
University of Zurich Recruiting
Zurich, Switzerland
Contact: Belen Valladares, MD    00412558806    Belen.Valladares@cereneo.ch   
Sponsors and Collaborators
Johns Hopkins University
Columbia University
University of Zurich
James S McDonnell Foundation
Investigators
Principal Investigator: John W. Krakauer, MD Johns Hopkins University
  More Information

Responsible Party: John W. Krakauer, Professor of Neurology and Neuroscience, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02292251     History of Changes
Other Study ID Numbers: JSMF220020220
First Submitted: November 8, 2014
First Posted: November 17, 2014
Last Update Posted: September 8, 2016
Last Verified: September 2016

Keywords provided by John W. Krakauer, Johns Hopkins University:
Stroke
Transcranial direct current stimulation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases