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FAME: Functional Assessment of a Myoelectric Orthosis Hand Orthoses

NCT04266158 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-04-11

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER

  • Northwestern University

    collaborator OTHER

  • Ohio State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2018-09-18
Completion
2018-09-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04266158 on ClinicalTrials.gov