CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Electrical Stimulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05198466
NCT05198466Phase 2Completed

Electrical Stimulation Therapy for Recovery of Hospital-acquired Weakness in Critically Ill COVID-19 Patients - A Proof of Concept Randomized Controlled Trial

Baylor College of Medicine·interventional·Posted Jan 20, 2022·Updated Mar 7, 2023

In Brief

A Phase 2 clinical trial evaluating Electrical Stimulation and Electrical Stimulation - Sham for COVID-19 and 2 related conditions. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAvazzia, Inc

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJan 20, 2022
Enrollment StartAug 18, 2021
Primary CompletionAug 18, 2022
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 4.5 years ago

Interventions

Electrical Stimulationdevice

Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).

Electrical Stimulation - Shamdevice

Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).