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MyHand 2: An Active Hand Orthosis for Stroke Patients (MyHand 2)

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.
 
ClinicalTrials.gov Identifier: NCT04436042
Recruitment Status : Not yet recruiting
First Posted : June 17, 2020
Last Update Posted : June 22, 2020
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Joel Stein, MD, Columbia University

Brief Summary:
This study is designed to further develop and test the hardware and software components of the MyHand device based on user feedback and results from our pilot study. The goal is to refine the device so that is more effective and easier for stroke patients to use to increase their hand function.

Condition or disease Intervention/treatment Phase
Stroke Hemiparesis Device: MyHand Device Not Applicable

Detailed Description:
From previous experimentation with the MyHand device, the investigators have determined that the device can improve the grasping ability of stroke patients. The investigators now aim to make the controls more intuitive and accurate for the users, to enable subjects to grasp a wider array of objects, to make the donning and doffing of the device easier, and to continue to assess the MyHand as it helps subjects in functional tasks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: MyHand 2: An Active Hand Orthosis for Stroke Patients
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : July 2025

Arm Intervention/treatment
Experimental: MyHand Treatment
Participants will use the MyHand device during repetitive grasp and release tasks.
Device: MyHand Device
These subjects may be asked to attend 1-10 sessions (approximately 90 mins) to trial a variety of device controls and/or components.




Primary Outcome Measures :
  1. Device Usability and Utility Questionnaire Score [ Time Frame: Up to 1 year at study completion ]

    Subjects will provide feedback about their perceptions of the device's usability and utility for post-stroke upper extremity recovery. Four questions will be rated on a 5-point Likert scale (1) strongly agree to (5) strongly disagree. Five questions will be rated on a 5-point reverse Likert scale (1) strongly disagree to (5) strongly agree.

    The 9 question survey has a score range of 9-45 with higher scores indicating higher levels of device usability and utility.




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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults over 18 years old
  • History of stroke(s) with most recent stroke at least six months ago
  • Upper extremity weakness with impaired ability to complete daily activities with affected hand
  • Full passive range of motion in all digits
  • Intact cognition to follow directions
  • Gross control of proximal upper extremity musculature

Exclusion Criteria:

  • Other neurological conditions besides stroke
  • Other orthopedic conditions to affected upper extremity
  • Significant spasticity in affected upper extremity that impairs device fit

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): NCT04436042


Contacts
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Contact: Michaela Fraser, MS, MPH 212-305-6722 mgf2124@cumc.columbia.edu
Contact: Joel Stein, MD 212-305-4818

Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Joel Stein Columbia University
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Responsible Party: Joel Stein, MD, Professor and Chair of the Department of Rehabilitation and Regenerative Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT04436042    
Other Study ID Numbers: AAAS8104
R01NS115652 ( U.S. NIH Grant/Contract )
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Joel Stein, MD, Columbia University:
Stroke
Rehabilitation
Hemiparesis
Robotics
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms