18 and older, any sex, with ICU Acquired Weakness. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Peak Acceleration Measured in Extensor Carpi Radialis LongusPrimary· 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.
Twitch acceleration at 20 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.476
± 0.467
No ICU Acquired Weakness Group
1.639
± 0.772
Twitch acceleration at 40 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.541
± 0.591
No ICU Acquired Weakness Group
1.608
± 0.803
Twitch acceleration at 60Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.373
± 0.402
No ICU Acquired Weakness Group
1.300
± 0.662
Peak Acceleration Measured in Tibialis AnteriorPrimary· 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.
Twitch acceleration at 20 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.105
± 0.151
No ICU Acquired Weakness Group
1.115
± 0.677
Twitch acceleration at 40 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.102
± 0.144
No ICU Acquired Weakness Group
1.029
± 0.585
Twitch acceleration at 60 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.101
± 0.153
No ICU Acquired Weakness Group
0.593
± 0.494
Time to Peak Acceleration Measured in Extensor Carpi Radialis LongusPrimary· 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.
Day 1 at 2 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
64.7
± 69.3
No ICU Acquired Weakness Group
119.5
± 55.1
Day 1 at 4 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
9.8
± 14.1
No ICU Acquired Weakness Group
64.6
± 56.2
Day 1 at 6 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
1.5
± 1.8
No ICU Acquired Weakness Group
33.7
± 53.2
Time to Peak Acceleration Measured in Tibialis AnteriorPrimary· 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.
Day 1 at 2 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
45.5
± 68.6
No ICU Acquired Weakness Group
100.1
± 53.0
Day 1 at 4 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
22.0
± 47.9
No ICU Acquired Weakness Group
32.3
± 43.3
Day 1 at 6 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
8.8
± 19.6
No ICU Acquired Weakness Group
19.3
± 27.1
End Acceleration Measured in Extensor Carpi Radialis LongusPrimary· 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.
Twitch acceleration at 20 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.289
± 0.328
No ICU Acquired Weakness Group
1.383
± 0.524
Twitch acceleration at 40 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.147
± 0.161
No ICU Acquired Weakness Group
1.021
± 0.755
Twitch acceleration at 60 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.239
± 0.263
No ICU Acquired Weakness Group
1.133
± 0.521
End Acceleration Measured in Tibialis AnteriorPrimary· 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.
Twitch acceleration at 20 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.057
± 0.081
No ICU Acquired Weakness Group
1.088
± 0.703
Twitch acceleration at 40 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.042
± 0.067
No ICU Acquired Weakness Group
0.767
± 0.517
Twitch acceleration at 60 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.059
± 0.083
No ICU Acquired Weakness Group
0.640
± 0.565
Fatigue Ratio Measured in Extensor Carpi Radialis LongusPrimary· 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.
Twitch acceleration at 20 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.578
± 0.266
No ICU Acquired Weakness Group
0.862
± 0.284
Twitch acceleration at 40 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.306
± 0.194
No ICU Acquired Weakness Group
0.562
± 0.349
Twitch acceleration at 60 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.639
± 0.136
No ICU Acquired Weakness Group
0.707
± 0.223
Fatigue Ratio Measured in Tibialis AnteriorPrimary· 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.
Twitch acceleration at 2 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.610
± 0.364
No ICU Acquired Weakness Group
0.899
± 0.351
Twitch acceleration at 4 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.471
± 0.414
No ICU Acquired Weakness Group
0.572
± 0.247
Twitch acceleration at 6 Hz
Group
Value
95% CI
ICU Acquired Weakness Group
0.437
± 0.414
No ICU Acquired Weakness Group
0.549
± 0.265
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 19 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04166630.