Skip to content

MyHand 2: An Active Hand Orthosis for Stroke Patients

MyHand 2: An Active Hand Orthosis for Stroke Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04436042
Acronym
MyHand 2
Enrollment
60
Registered
2020-06-17
Start date
2020-03-06
Completion date
2029-01-01
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiparesis, Stroke

Keywords

Stroke, Rehabilitation, Hemiparesis, Robotics

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.

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.

Interventions

DEVICEMyHand Device

These subjects may be asked to attend 1-40 sessions (approximately 90 mins) to trial a variety of device controls and/or components.

Sponsors

Columbia University
Lead SponsorOTHER
National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Device Usability and Utility Questionnaire ScoreUp to 1 year at study completionSubjects 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.

Countries

United States

Contacts

CONTACTCarley Teachout, MS
ct3351@cumc.columbia.edu212-305-6722
CONTACTJoel Stein, MD
212-305-4818
PRINCIPAL_INVESTIGATORJoel Stein, MD

Columbia University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026