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Development of a FES Device for Hand Use During Arm Activities Following Stroke

NCT03986216 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-03-07

Study results available
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Summary

The goal of the study is to develop an individualized, synergy resistant, portable electromyographic (EMG)-driven functional electrical stimulation (FES) device that allows for Reliable and Intuitive control of hand (ReIn-Hand) opening while using the paretic arm during lifting and reaching. Furthermore, to enable sufficient practice intensity both in the clinic and at home, the investigators propose to develop the ReIn-Hand device with easy-to-use utilities by developing a user-customized forearm/hand orthosis with embedded EMG recording and stimulation electrode. To test the device feasibility, a small clinical trial will be conducted. Information related to the clinical trial will be provided below.

Conditions

Interventions

DEVICE

ReIn-Hand device assisted home-based practice

Practice reach-grasp-retrieve-release at home with the aid of ReIn-hand device

Sponsors & Collaborators

Principal Investigators

  • Jun Yao, PhD · Department of Physical Therapy and Human Movement Sciences, Northwestern University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-17
Primary Completion
2021-03-18
Completion
2021-03-18
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03986216 on ClinicalTrials.gov