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NCT Number: NCT04436042

MyHand 2: An Active Hand Orthosis for Stroke Patients

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Carley Teachout, MS

CONTACT

[email protected]

212-305-6722

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MyHand Device

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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carley Teachout, MS

CONTACT

[email protected]

212-305-6722

Joel Stein, MD

CONTACT

212-305-4818

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Acronym: MyHand 2

Important dates

Study start
2020
Primary completion
2028
Study completion
2029
First posted
Jun 17, 2020
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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