NCT04436042 · Columbia University
MyHand 2: An Active Hand Orthosis for Stroke Patients
(MyHand 2)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
MyHand Device
These subjects may be asked to attend 1-40 sessions (approximately 90 mins) to trial a variety of device controls and/or components.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations