NCT04266158

FAME: Functional Assessment of a Myoelectric Orthosis Hand Orthoses

Functional Assistance Provided by Myoelectric Elbow-wrist- Hand Orthosis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary study objective is to compare post-stroke upper extremity (UE) movement while wearing a brace called the MyoPro 2 Motion G versus UE movement while wearing a resting splint and no device in stroke survivors with moderate UE dysfunction. During the study, subjects will undergo general training in the operation of the EMG-controlled orthosis and the comparison orthosis, and then guided through a series of standard clinical outcome measures. These outcome measures will allow the researchers to directly compare the relative benefit of the MyoPro 2 Motion G with a resting hand splint and no device in reducing UE impairment and increasing UE dexterity and functional task performance.

Conditions

• Paresis
• Stroke

Interventions

Type	Name	Description
DEVICE	Myoelectric UE Device-UE Orthosis-No Device	all subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects.

Timeline

• Start date: 2017-10-01
• Primary completion: 2018-09-18
• Completion: 2018-09-18
• First posted: 2020-02-12
• Last updated: 2022-04-11
• Results posted: 2022-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study