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Electrical Stimulation for Critically Ill Covid-19 Patients

NCT04685213 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-02-16

Study results available
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Summary

Unfortunately, hospital-acquired weakness is highly prevalent among COVID-19 hospitalized patients, who often require prolonged bed-rest or paralytics for an extended period of time in order to maintain oxygenation. Prolonged bed rest has been associated with pronounced loss of muscle mass that can exceed 10% over the 1st week, which leads to functional impairment and complications post-hospital discharge. Physical therapy and in-hospital mobility program may reduce the incident of hospital-acquired weakness, but they are often impractical for COVID-19 patients. In particular, conventional mobility programs are challenging for those who are being treated in an intensive Care Unit. The purpose of this study is to test feasibility and proof-of-concept effectiveness of daily use of lower extremity electrical stimulation (EE) therapy, as a practical solution to address lower extremity muscle deconditioning, to address chronic consequences of COVID-19 including hospital-acquired weakness.

Conditions

  • Covid19
  • Muscle Atrophy
  • Muscle Weakness

Interventions

DEVICE

Electrical Stimulation

Subjects will receive an active electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).

DEVICE

Electrical Stimulation - Sham

Subjects will receive a sham electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).

Sponsors & Collaborators

  • Avazzia, Inc

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-22
Primary Completion
2021-03-18
Completion
2021-03-18
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04685213 on ClinicalTrials.gov