NCT04436042

MyHand 2: An Active Hand Orthosis for Stroke Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Hemiparesis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-03-06
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2020-06-17
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study