Diagnosing Intensive Care Unit (ICU) Acquired Weakness

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04166630
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.2
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

The goal of this study is to develop a non-invasive test to diagnose intensive care unit (ICU) acquired weakness that can be administered to both responsive and non-responsive patients. Study participation will involve the measurement of muscle fatigue during a single 30 minute session. Skeletal muscle will be stimulated with an FDA approved clinical electrical stimulator and accelerations will be passively recorded with an accelerometer.

Condition or Disease	Intervention/Treatment	Phase
ICU Acquired Weakness	Device: Clinical Electrical Stimulator	N/A

Detailed Description

The primary purpose of this study is to develop a procedure to identify intensive care unit (ICU) acquired weakness. This condition occurs in a subset of people admitted into the ICU, and is associated with a 30% increased risk of death before discharge from the ICU. There are currently major limitations in the ability to diagnose ICU acquired weakness, making it difficult to study. The goal is to develop a non-invasive test that can be administered to both responsive and non-responsive patients. The current proposal will focus on replicating the results of previous research using motion detecting accelerometers to measure fatigue in human skeletal muscles. This study is designed to test out the procedures in patients who have been transferred from the ICU to a lower level of care so that follow-on studies can be designed to help mitigate this condition in the ICU.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Accelerometer Motion to Measure Muscle Fatigue in Critically Ill Patients
• Actual Study Start Date: Feb 2, 2021
• Actual Primary Completion Date: Jun 11, 2021
• Actual Study Completion Date: Jun 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ICU Acquired Weakness Group Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.	Device: Clinical Electrical Stimulator; Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).; Other Names: Vectra Genisys Therapy System
Experimental: No ICU Acquired Weakness Group Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.	Device: Clinical Electrical Stimulator; Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).; Other Names: Vectra Genisys Therapy System

Outcome Measures

Primary Outcome Measures

1. Peak Acceleration Measured in Extensor Carpi Radialis Longus [Day 1]

   The highest acceleration over a single muscle twitch will be used as the peak acceleration. Peak acceleration will be measured in acceleration in number of times gravity (g). Higher twitch acceleration is a better response.

2. Peak Acceleration Measured in Tibialis Anterior [Day 1]

   The highest acceleration over a single muscle twitch will be used as the peak acceleration. Peak acceleration will be measured in acceleration in number of times gravity (g). Higher twitch acceleration is a better response.

3. Time to Peak Acceleration Measured in Extensor Carpi Radialis Longus [Day 1 at 2 Hz, Day 1 at 4 Hz, Day 1 at 6 Hz]

   The time, in seconds, until peak acceleration is reached will be assessed at 2, 4 and 6 Hz. There is not a reference range for the time to peak force and at this time it is unclear if a shorter or longer time to peak force indicates a more desirable state of health.

4. Time to Peak Acceleration Measured in Tibialis Anterior [Day 1]

   The time, in seconds, until peak acceleration is reached will be assessed. There is not a reference range for the time to peak force and at this time it is unclear if a shorter or longer time to peak force indicates a more desirable state of health.

5. End Acceleration Measured in Extensor Carpi Radialis Longus [Day 1]

   End acceleration is the twitch acceleration averaged over 5 twitches over the last second of stable twitches within the stimulation period. A reference range has not yet been established for this measurement.

6. End Acceleration Measured in Tibialis Anterior [Day 1]

   End acceleration is the twitch acceleration averaged over 5 twitches over the last second of stable twitches within the stimulation period. A reference range has not yet been established for this measurement.

7. Fatigue Ratio Measured in Extensor Carpi Radialis Longus [Day 1]

   Fatigue ratio is the ending acceleration divided by peak acceleration during a given stimulation period. A reference range has not yet been established for this measurement. A higher ratio indicates less change from maximum. A lower score would indicate worse outcome.

8. Fatigue Ratio Measured in Tibialis Anterior [Day 1]

   Fatigue ratio is the ending acceleration divided by peak acceleration during a given stimulation period. A reference range has not yet been established for this measurement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients transferred from the ICU to a lower level of care within the past 7 days

• Mechanical ventilation for greater than 7 days while in the ICU

• Ability to understand English and provide written consent

Exclusion Criteria:

• Vulnerable populations including: patients who are pregnant or prisoners

• Patients who are unable to understand English or provide written consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grady Health System	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: Randi Smith, MD, MPH, Emory University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 27, 2019

More Information

Publications

None provided.

• Responsible Party: Randi Smith, Assistant Professor, Emory University
• ClinicalTrials.gov Identifier: NCT04166630
• Other Study ID Numbers: IRB00109793
• First Posted: Nov 18, 2019
• Last Update Posted: Aug 19, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Randi Smith, Assistant Professor, Emory University: Biofeedback; Muscular disorders; Neuromuscular disorders; Rehabilitation
• Additional relevant MeSH terms: Asthenia

Study Results

Participant Flow

Arm/Group Title	ICU Acquired Weakness Group	No ICU Acquired Weakness Group
Arm/Group Description	Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).	Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
Period Title: Overall Study
STARTED	5	17
COMPLETED	5	16
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	ICU Acquired Weakness Group	No ICU Acquired Weakness Group	Total
Arm/Group Description	Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).	Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).	Total of all reporting groups
Overall Participants	5	17	22
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 60%	14 82.4%	17 77.3%
>=65 years	2 40%	3 17.6%	5 22.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.5 (21.3)	44.6 (21.4)	45.5 (21.0)
Sex: Female, Male (Count of Participants)
Female	1 20%	2 11.8%	3 13.6%
Male	4 80%	15 88.2%	19 86.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	4 23.5%	4 18.2%
Not Hispanic or Latino	5 100%	13 76.5%	18 81.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 100%	11 64.7%	16 72.7%
White	0 0%	2 11.8%	2 9.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	4 23.5%	4 18.2%
Region of Enrollment (participants) [Number]
United States	5 100%	17 100%	22 100%

Outcome Measures

1. Primary Outcome

Title	Peak Acceleration Measured in Extensor Carpi Radialis Longus
Description	The highest acceleration over a single muscle twitch will be used as the peak acceleration. Peak acceleration will be measured in acceleration in number of times gravity (g). Higher twitch acceleration is a better response.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

2 subjects data sets in the No ICU Acquired Weakness Group, were lost due to device malfunction. One additional subject had no data due to a malfunction with the accelerometer firmware The device manufacturer was contacted and were able to update the device, but no data was recorded during that trial.

Arm/Group Title	ICU Acquired Weakness Group	No ICU Acquired Weakness Group
Arm/Group Description	Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).	Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
Measure Participants	5	13
Twitch acceleration at 20 Hz	0.476 (0.467)	1.639 (0.772)
Twitch acceleration at 40 Hz	0.541 (0.591)	1.608 (0.803)
Twitch acceleration at 60Hz	0.373 (0.402)	1.300 (0.662)

2. Primary Outcome

Title	Peak Acceleration Measured in Tibialis Anterior
Description	The highest acceleration over a single muscle twitch will be used as the peak acceleration. Peak acceleration will be measured in acceleration in number of times gravity (g). Higher twitch acceleration is a better response.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

1 subject data set in the No ICU Acquired Weakness Group, could not be analyzed due to excessive subject motion during the trial. One additional subject had no data due to a malfunction with the accelerometer firmware The device manufacturer was contacted and were able to update the device, but no data was recorded during that trial.

Arm/Group Title	ICU Acquired Weakness Group	No ICU Acquired Weakness Group
Arm/Group Description	Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).	Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
Measure Participants	5	14
Twitch acceleration at 20 Hz	0.105 (0.151)	1.115 (0.677)
Twitch acceleration at 40 Hz	0.102 (0.144)	1.029 (0.585)
Twitch acceleration at 60 Hz	0.101 (0.153)	0.593 (0.494)

3. Primary Outcome

Title	Time to Peak Acceleration Measured in Extensor Carpi Radialis Longus
Description	The time, in seconds, until peak acceleration is reached will be assessed at 2, 4 and 6 Hz. There is not a reference range for the time to peak force and at this time it is unclear if a shorter or longer time to peak force indicates a more desirable state of health.
Time Frame	Day 1 at 2 Hz, Day 1 at 4 Hz, Day 1 at 6 Hz

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ICU Acquired Weakness Group	No ICU Acquired Weakness Group
Arm/Group Description	Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).	Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
Measure Participants	5	13
Day 1 at 2 Hz	64.7 (69.3)	119.5 (55.1)
Day 1 at 4 Hz	9.8 (14.1)	64.6 (56.2)
Day 1 at 6 Hz	1.5 (1.8)	33.7 (53.2)

4. Primary Outcome

Title	Time to Peak Acceleration Measured in Tibialis Anterior
Description	The time, in seconds, until peak acceleration is reached will be assessed. There is not a reference range for the time to peak force and at this time it is unclear if a shorter or longer time to peak force indicates a more desirable state of health.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ICU Acquired Weakness Group	No ICU Acquired Weakness Group
Arm/Group Description	Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).	Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
Measure Participants	5	14
Day 1 at 2 Hz	45.5 (68.6)	100.1 (53.0)
Day 1 at 4 Hz	22.0 (47.9)	32.3 (43.3)
Day 1 at 6 Hz	8.8 (19.6)	19.3 (27.1)

5. Primary Outcome

Title	End Acceleration Measured in Extensor Carpi Radialis Longus
Description	End acceleration is the twitch acceleration averaged over 5 twitches over the last second of stable twitches within the stimulation period. A reference range has not yet been established for this measurement.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

2 subjects data sets in the No ICU Acquired Weakness Group, were lost due to device malfunction. One additional subject had no data due to a malfunction with the accelerometer firmware The device manufacturer was contacted and were able to update the device, but no data was recorded during that trial.

Arm/Group Title	ICU Acquired Weakness Group	No ICU Acquired Weakness Group
Arm/Group Description	Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).	Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
Measure Participants	5	13
Twitch acceleration at 20 Hz	0.289 (0.328)	1.383 (0.524)
Twitch acceleration at 40 Hz	0.147 (0.161)	1.021 (0.755)
Twitch acceleration at 60 Hz	0.239 (0.263)	1.133 (0.521)

6. Primary Outcome

Title	End Acceleration Measured in Tibialis Anterior
Description	End acceleration is the twitch acceleration averaged over 5 twitches over the last second of stable twitches within the stimulation period. A reference range has not yet been established for this measurement.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

1 subject data set on the No ICU Acquired Weakness Group, could not be analyzed due to excessive subject motion during the trial. One additional subject had no data due to a malfunction with the accelerometer firmware The device manufacturer was contacted and were able to update the device, but no data was recorded during that trial.

Arm/Group Title	ICU Acquired Weakness Group	No ICU Acquired Weakness Group
Arm/Group Description	Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).	Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
Measure Participants	5	14
Twitch acceleration at 20 Hz	0.057 (0.081)	1.088 (0.703)
Twitch acceleration at 40 Hz	0.042 (0.067)	0.767 (0.517)
Twitch acceleration at 60 Hz	0.059 (0.083)	0.640 (0.565)

7. Primary Outcome

Title	Fatigue Ratio Measured in Extensor Carpi Radialis Longus
Description	Fatigue ratio is the ending acceleration divided by peak acceleration during a given stimulation period. A reference range has not yet been established for this measurement. A higher ratio indicates less change from maximum. A lower score would indicate worse outcome.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

The team was unable to calculate change for 2 subjects in the ICU Acquired Weakness group. These had palpable contractions, but not large enough to displace the skin above the muscle. 1 subject's results were accidentally deleted and the device manufacturer deemed them unrecoverable. Another subject had no data due to software malfunction, the device manufacturer was able to update the device, but no data was recorded during that trial.

Arm/Group Title	ICU Acquired Weakness Group	No ICU Acquired Weakness Group
Arm/Group Description	Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).	Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
Measure Participants	3	13
Twitch acceleration at 20 Hz	0.578 (0.266)	0.862 (0.284)
Twitch acceleration at 40 Hz	0.306 (0.194)	0.562 (0.349)
Twitch acceleration at 60 Hz	0.639 (0.136)	0.707 (0.223)

8. Primary Outcome

Title	Fatigue Ratio Measured in Tibialis Anterior
Description	Fatigue ratio is the ending acceleration divided by peak acceleration during a given stimulation period. A reference range has not yet been established for this measurement.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

The team was unable to calculate change for 3 subjects in the ICU Acquired Weakness group. These had palpable contractions, but not large enough to displace the skin above the muscle. 1 subject's results were accidentally deleted and the device manufacturer deemed them unrecoverable. Another subject had no data due to software malfunction, the device manufacturer was able to update the device, but no data was recorded during that trial.

Arm/Group Title	ICU Acquired Weakness Group	No ICU Acquired Weakness Group
Arm/Group Description	Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).	Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
Measure Participants	2	14
Twitch acceleration at 2 Hz	0.610 (0.364)	0.899 (0.351)
Twitch acceleration at 4 Hz	0.471 (0.414)	0.572 (0.247)
Twitch acceleration at 6 Hz	0.437 (0.414)	0.549 (0.265)

Adverse Events

Time Frame	Day 1
Arm/Group Title	ICU Acquired Weakness Group		No ICU Acquired Weakness Group
Arm/Group Description	Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).		Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator. Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
All Cause Mortality
	ICU Acquired Weakness Group		No ICU Acquired Weakness Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/17 (0%)
Serious Adverse Events
	ICU Acquired Weakness Group		No ICU Acquired Weakness Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	ICU Acquired Weakness Group		No ICU Acquired Weakness Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.