Trial Outcomes & Findings for Electrical Stimulation for Critically Ill Covid-19 Patients (NCT NCT04685213)
NCT ID: NCT04685213
Last Updated: 2023-02-16
Results Overview
Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).
COMPLETED
PHASE1
19 participants
an average of 2 weeks (Phase I)
2023-02-16
Participant Flow
Patients were randomized into intervention (n=9), and control (n=10) groups.
Participant milestones
| Measure |
Active E-Stim (Phase I)
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
|
Sham E-Stim (Phase I)
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Electrical Stimulation for Critically Ill Covid-19 Patients
Baseline characteristics by cohort
| Measure |
Active E-Stim (Phase I)
n=9 Participants
Subjects enrolled in Phase I will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
|
Sham E-Stim (Phase I)
n=10 Participants
Subjects enrolled in Phase I will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 2.9 • n=7 Participants
|
65.8 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: an average of 2 weeks (Phase I)Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).
Outcome measures
| Measure |
Active E-Stim (Phase I)
n=8 Participants
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
|
Sham E-Stim (Phase I)
n=8 Participants
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
|
|---|---|---|
|
Change in Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation
|
352 milliVolts
Standard Deviation 37
|
323 milliVolts
Standard Deviation 18
|
PRIMARY outcome
Timeframe: an average of 2 weeks (Phase I)Ankle strength will be measured in response to the average of three 5-second dorsiflexion maximum voluntary isometric contractions per 30 seconds of relaxation in-between using a dynamometer (RoMech Digital Hanging Scale).
Outcome measures
| Measure |
Active E-Stim (Phase I)
n=8 Participants
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
|
Sham E-Stim (Phase I)
n=8 Participants
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
|
|---|---|---|
|
Change in Ankle Strength
|
3.0 kg
Standard Deviation 1.6
|
2.1 kg
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: an average of 2 weeks (Phase I)Percentage of tissue oxygen saturation (SatO2) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time SatO2 level in superficial tissue. The metatarsus area including the five toes will be traced.
Outcome measures
| Measure |
Active E-Stim (Phase I)
n=8 Participants
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
|
Sham E-Stim (Phase I)
n=8 Participants
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
|
|---|---|---|
|
Change in Plantar Tissue Oxygen Saturation/Consumption
|
69.2 Percentage of oxygen saturation
Standard Deviation 8.9
|
67.2 Percentage of oxygen saturation
Standard Deviation 9.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: an average of 2 weeks (Phase I)Assessment via the total score of Morse Fall Scale, which is the sum of six variables' score depending on presence or absence of: 1. History of falling: Score 25 for falls during the present hospital admission or immediate history of physiological falls; if not, score 0. 2. Secondary diagnosis: 15 if there is more than one medical diagnosis; if not, score 0. 3. Ambulatory aids: 0 for walking without a walking aid, uses wheelchair, or is on bedrest; 15 for use of crutches, a cane, or a walker; 30 for ambulation clutching onto the furniture for support. 4. Intravenous therapy: 20 for intravenous apparatus or a heparin lock inserted; if not, score 0. 5. Gait: 0 if has a normal gait; 10 weak gait; 20 impaired gait. 6. Mental status: patient's own self-assessment; 0 if normal; 15 if impaired. Scale: Minimum score or low risk: \< 24 points Medium score or Moderate risk: 25-45 points Maximum score or high risk: \> 45 points.
Outcome measures
| Measure |
Active E-Stim (Phase I)
n=8 Participants
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
|
Sham E-Stim (Phase I)
n=8 Participants
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
|
|---|---|---|
|
Likelihood of Falling
|
39.3 score on a scale
Standard Deviation 11
|
46.2 score on a scale
Standard Deviation 11.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: An average of 2 weeks (Phase I)Gastrocnemius Muscle Strength will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).
Outcome measures
| Measure |
Active E-Stim (Phase I)
n=8 Participants
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
|
Sham E-Stim (Phase I)
n=8 Participants
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for up to 2 weeks.
|
|---|---|---|
|
Change in Gastrocnemius Muscle Strength
|
6.5 milliVolts
Standard Deviation 0.39
|
6.5 milliVolts
Standard Deviation 0.36
|
Adverse Events
Active E-Stim (Phase I)
Sham E-Stim (Phase I)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60