Trial Outcomes & Findings for Testing of a New Therapeutic Vibration Device to Reduce Neuromuscular Weakness in Hospitalized Patients (NCT NCT03479008)

Last Updated: 2024-05-30

Results Overview

Change in tissue regional hemoglobin oxygen saturation (rSO2) using near infrared spectroscopy of the thighs,calf, and biceps Baseline measurements were taken for 1 minute and vibration period was for 10 minutes. The mean value of rSO2 for 1 minute preceding vibration was computed as the baseline value. For the data collected during vibration, a moving average peak analysis for every 1 minute for 10 minutes of rSO2 data was carried out. The maximum value of the moving average was selected as the mean value of vibration. The moving average peak analysis was independently conducted for all three measurements from GL, RF and BB.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

10 minutes

Results posted on

2024-05-30

Participant Flow

Prior to actual testing for the outcomes listed in this registration, 8 participants were recruited and consented for tuning and characterizing the device prior to structured testing.

6 participants consented for testing the device did not come in for their first appointment.

Participant milestones

Participant milestones
Measure	Healthy Volunteers (Iterative Device Development) This phase recruited healthy volunteers who were be vibrated with the prototype device using various vibration frequencies to determine which frequency produces the optimal physiologic response. Physiologic responses were determined with a number of devices capable of measuring such things as tissue oxygenation, oxygen consumption, and muscle activity. Volunteers were randomized to receive alternating 5 minute episodes of various vibration frequencies. Therapeutic Vibration Device: The Therapeutic Vibration Device is capable of applying force through the axial skeletal spine, through bidirectional compression loading (or prestressing) between the shoulder and the plantar surfaces of the feet. It is placed around the body like a mobile frame so that the applied vibration can affect the whole body. The vibration actuators (drivers) are mobile and can vary in size, frequency response, and force. The design minimizes the possibility of mechanical interference for ventilated/intubated patients.
Overall Study STARTED	22
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Volunteers (Iterative Device Development) This phase recruited healthy volunteers who were be vibrated with the prototype device using various vibration frequencies to determine which frequency produces the optimal physiologic response. Physiologic responses were determined with a number of devices capable of measuring such things as tissue oxygenation, oxygen consumption, and muscle activity. Volunteers were randomized to receive alternating 5 minute episodes of various vibration frequencies. Therapeutic Vibration Device: The Therapeutic Vibration Device is capable of applying force through the axial skeletal spine, through bidirectional compression loading (or prestressing) between the shoulder and the plantar surfaces of the feet. It is placed around the body like a mobile frame so that the applied vibration can affect the whole body. The vibration actuators (drivers) are mobile and can vary in size, frequency response, and force. The design minimizes the possibility of mechanical interference for ventilated/intubated patients.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Volunteers (Iterative Device Development) n=19 Participants This phase recruited healthy volunteers who were be vibrated with the prototype device using various vibration frequencies to determine which frequency produces the optimal physiologic response. Physiologic responses were determined with a number of devices capable of measuring such things as tissue oxygenation, oxygen consumption, and muscle activity. Volunteers were randomized to receive alternating 5 minute episodes of various vibration frequencies. Therapeutic Vibration Device: The Therapeutic Vibration Device is capable of applying force through the axial skeletal spine, through bidirectional compression loading (or prestressing) between the shoulder and the plantar surfaces of the feet. It is placed around the body like a mobile frame so that the applied vibration can affect the whole body. The vibration actuators (drivers) are mobile and can vary in size, frequency response, and force. The design minimizes the possibility of mechanical interference for ventilated/intubated patients.
Age, Continuous	51.7 years STANDARD_DEVIATION 19.5 • n=19 Participants
Sex: Female, Male Female	9 Participants n=19 Participants
Sex: Female, Male Male	10 Participants n=19 Participants
Region of Enrollment United States	19 Participants n=19 Participants

PRIMARY outcome

Timeframe: 10 minutes

Population: One dataset was discarded due to poor data quality due to instrumentation issues encountered during testing.

Outcome measures

Outcome measures
Measure	Healthy Volunteers (1st Iteration of Device Development) n=18 Participants This phase recruited healthy volunteers who were be vibrated with the prototype device using various vibration frequencies to determine which frequency produces the optimal physiologic response. Physiologic responses were determined with a number of devices capable of measuring such things as tissue oxygenation, oxygen consumption, and muscle activity. Volunteers were randomized to receive alternating 5 minute episodes of various vibration frequencies. Therapeutic Vibration Device: The Therapeutic Vibration Device is capable of applying force through the axial skeletal spine, through bidirectional compression loading (or prestressing) between the shoulder and the plantar surfaces of the feet. It is placed around the body like a mobile frame so that the applied vibration can affect the whole body. The vibration actuators (drivers) are mobile and can vary in size, frequency response, and force. The design minimizes the possibility of mechanical interference for ventilated/intubated patients.
Change in Regional Hemoglobin Oxygen Saturation Thighs (baseline)	75.65 percent of oxygenation Standard Error 0.98
Change in Regional Hemoglobin Oxygen Saturation Thighs (during stimulation	77.01 percent of oxygenation Standard Error 1.09
Change in Regional Hemoglobin Oxygen Saturation Calf muscle (baseline)	73.83 percent of oxygenation Standard Error 0.93
Change in Regional Hemoglobin Oxygen Saturation Calf (during stimulation)	77.09 percent of oxygenation Standard Error 1.13
Change in Regional Hemoglobin Oxygen Saturation Biceps (baseline)	72.23 percent of oxygenation Standard Error 1.27
Change in Regional Hemoglobin Oxygen Saturation Biceps (during stimulation)	74.15 percent of oxygenation Standard Error 1.40

PRIMARY outcome

Timeframe: baseline and during device use (10 minutes)

Population: Three datasets were discarded due to poor data quality due to instrumentation issues encountered during testing.

Oxygen consumption using a VO2 monitor and mask For the baseline data, a mean of 3 minutes of the segment preceding vibration was computed. For the data collected during vibration, a moving average peak analysis for every 3 minutes for 10 minutes of VO2, VCO2 data was carried out. The maximum value of the moving average was selected as the mean value. This methodology of segment extraction precluded the possibility of picking up short transient changes in metabolic data and helped ensure selection of steady set of values of metabolic variables which estimated the true response of the participant.

Outcome measures

Outcome measures
Measure	Healthy Volunteers (1st Iteration of Device Development) n=16 Participants This phase recruited healthy volunteers who were be vibrated with the prototype device using various vibration frequencies to determine which frequency produces the optimal physiologic response. Physiologic responses were determined with a number of devices capable of measuring such things as tissue oxygenation, oxygen consumption, and muscle activity. Volunteers were randomized to receive alternating 5 minute episodes of various vibration frequencies. Therapeutic Vibration Device: The Therapeutic Vibration Device is capable of applying force through the axial skeletal spine, through bidirectional compression loading (or prestressing) between the shoulder and the plantar surfaces of the feet. It is placed around the body like a mobile frame so that the applied vibration can affect the whole body. The vibration actuators (drivers) are mobile and can vary in size, frequency response, and force. The design minimizes the possibility of mechanical interference for ventilated/intubated patients.
VO2 and VCO2 VO2 (baseline)	3.19 ml/(kg*min) Standard Error 0.16
VO2 and VCO2 VO2 (during stimulation)	3.84 ml/(kg*min) Standard Error .22
VO2 and VCO2 VCO2 (baseline)	2.54 ml/(kg*min) Standard Error .14
VO2 and VCO2 VCO2 (during stimulation)	3.07 ml/(kg*min) Standard Error 0.18

PRIMARY outcome

Timeframe: 10 minutes

Population: Three datasets were discarded due to poor data quality due to instrumentation issues encountered during testing.

For the baseline data, a mean of 3 minutes of the segment preceding vibration was computed. For the data collected during vibration, a moving average peak analysis for every 3 minutes for 10 minutes of EE data was carried out. The maximum value of the moving average was selected as the mean value. This methodology of segment extraction precluded the possibility of picking up short transient changes in metabolic data and helped ensure selection of steady set of values of metabolic variables which estimated the true response of the participant.

Outcome measures

Outcome measures
Measure	Healthy Volunteers (1st Iteration of Device Development) n=16 Participants This phase recruited healthy volunteers who were be vibrated with the prototype device using various vibration frequencies to determine which frequency produces the optimal physiologic response. Physiologic responses were determined with a number of devices capable of measuring such things as tissue oxygenation, oxygen consumption, and muscle activity. Volunteers were randomized to receive alternating 5 minute episodes of various vibration frequencies. Therapeutic Vibration Device: The Therapeutic Vibration Device is capable of applying force through the axial skeletal spine, through bidirectional compression loading (or prestressing) between the shoulder and the plantar surfaces of the feet. It is placed around the body like a mobile frame so that the applied vibration can affect the whole body. The vibration actuators (drivers) are mobile and can vary in size, frequency response, and force. The design minimizes the possibility of mechanical interference for ventilated/intubated patients.
Energy Expenditure Baseline	1.12 kcal/minute Standard Error 0.07
Energy Expenditure Vibration	1.35 kcal/minute Standard Error 0.09

PRIMARY outcome

Timeframe: 10 minutes

Population: Three datasets were discarded due to poor data quality due to instrumentation issues encountered during testing.

For the baseline data, a mean of 3 minutes of the segment preceding vibration was computed. For the data collected during vibration, a moving average peak analysis for every 3 minutes for 10 minutes of data was carried out. The maximum value of the moving average was selected as the mean value. This methodology of segment extraction precluded the possibility of picking up short transient changes in metabolic data and helped ensure selection of steady set of values of metabolic variables which estimated the true response of the participant.

Outcome measures

Outcome measures
Measure	Healthy Volunteers (1st Iteration of Device Development) n=16 Participants This phase recruited healthy volunteers who were be vibrated with the prototype device using various vibration frequencies to determine which frequency produces the optimal physiologic response. Physiologic responses were determined with a number of devices capable of measuring such things as tissue oxygenation, oxygen consumption, and muscle activity. Volunteers were randomized to receive alternating 5 minute episodes of various vibration frequencies. Therapeutic Vibration Device: The Therapeutic Vibration Device is capable of applying force through the axial skeletal spine, through bidirectional compression loading (or prestressing) between the shoulder and the plantar surfaces of the feet. It is placed around the body like a mobile frame so that the applied vibration can affect the whole body. The vibration actuators (drivers) are mobile and can vary in size, frequency response, and force. The design minimizes the possibility of mechanical interference for ventilated/intubated patients.
Minute Variation Baseline	7.09 liters/minute Standard Error 0.40
Minute Variation Vibration	8.50 liters/minute Standard Error 0.55

PRIMARY outcome

Timeframe: 10 minutes

Population: Three datasets were discarded due to poor data quality due to instrumentation issues encountered during testing.

For the baseline data, a mean of 3 minutes of the segment preceding vibration was computed. For the data collected during vibration, a moving average peak analysis for every 3 minutes for 10 minutes of data was carried out. The maximum value of the moving average was selected as the mean value. This methodology of segment extraction precluded the possibility of picking up short transient changes in metabolic data and helped ensure selection of steady set of values of metabolic variables which estimated the true response of the participant.

Outcome measures

Outcome measures
Measure	Healthy Volunteers (1st Iteration of Device Development) n=16 Participants This phase recruited healthy volunteers who were be vibrated with the prototype device using various vibration frequencies to determine which frequency produces the optimal physiologic response. Physiologic responses were determined with a number of devices capable of measuring such things as tissue oxygenation, oxygen consumption, and muscle activity. Volunteers were randomized to receive alternating 5 minute episodes of various vibration frequencies. Therapeutic Vibration Device: The Therapeutic Vibration Device is capable of applying force through the axial skeletal spine, through bidirectional compression loading (or prestressing) between the shoulder and the plantar surfaces of the feet. It is placed around the body like a mobile frame so that the applied vibration can affect the whole body. The vibration actuators (drivers) are mobile and can vary in size, frequency response, and force. The design minimizes the possibility of mechanical interference for ventilated/intubated patients.
Tidal Volume Baseline	0.55 liters Standard Error 0.04
Tidal Volume Vibration	0.68 liters Standard Error 0.09

PRIMARY outcome

Timeframe: baseline and during intervention (not exceeding 1 minute)

Simultaneous multi-frequency synchronous excitation was the stimulus, using 15 Hz at shoulders and 25 Hz at feet. Baseline EMG data were recorded prior to commencement of vibration; a 1 second segment was extracted for post processing. For computing muscle activation during vibration, a 10 second EMG segment was extracted after 1 minute of start of the vibration. Extracted signals were filtered to remove artifacts; similar filtering procedures were carried out for EMG signals recorded during MVIC tests and baseline recording. The root-mean square values of EMG signals of vibration and MVIC were calculated. Normalization to MVIC followed (Vibration EMGRMS)/(MVIC EMGRMS) × 100. Bias calculated using (Filtered EMGRMS @ baseline)/(Unfiltered EMGRMS @ baseline); bias-corrected EMG during vibration computed using (Vibration EMGRMS /Bias). Therefore each muscle site has only 1 reported value, representative of the combined effect of multi-frequency excitation provided at shoulders and feet.

Outcome measures

Outcome measures
Measure	Healthy Volunteers (1st Iteration of Device Development) n=19 Participants This phase recruited healthy volunteers who were be vibrated with the prototype device using various vibration frequencies to determine which frequency produces the optimal physiologic response. Physiologic responses were determined with a number of devices capable of measuring such things as tissue oxygenation, oxygen consumption, and muscle activity. Volunteers were randomized to receive alternating 5 minute episodes of various vibration frequencies. Therapeutic Vibration Device: The Therapeutic Vibration Device is capable of applying force through the axial skeletal spine, through bidirectional compression loading (or prestressing) between the shoulder and the plantar surfaces of the feet. It is placed around the body like a mobile frame so that the applied vibration can affect the whole body. The vibration actuators (drivers) are mobile and can vary in size, frequency response, and force. The design minimizes the possibility of mechanical interference for ventilated/intubated patients.
EMG Baseline bellies of soleus (SO)	13.10 percentage of MVC Standard Error 1.72
EMG During vibration bellies of soleus (SO)	62.67 percentage of MVC Standard Error 17.42
EMG Baseline tibialis anterior (TA)	5.15 percentage of MVC Standard Error 0.75
EMG During vibration tibialis anterior (TA)	11.59 percentage of MVC Standard Error 2.36
EMG Baseline gastroenemius lateralis (GL)	3.17 percentage of MVC Standard Error 0.24
EMG During vibration gastroenemius lateralis (GL)	7.14 percentage of MVC Standard Error 1.16
EMG Baseline vastus medialis (VM)	5.41 percentage of MVC Standard Error 0.64
EMG During vibration vastus medialis (VM)	8.52 percentage of MVC Standard Error 1.25
EMG Baseline vastus lateralis (VL)	4.33 percentage of MVC Standard Error 0.52
EMG During vibration vastus lateralis (VL)	6.57 percentage of MVC Standard Error 0.73
EMG Baselin rectus femoris (RF)	4.82 percentage of MVC Standard Error 1.56
EMG During vibration rectus femoris (RF)	5.58 percentage of MVC Standard Error 0.51
EMG Baseline semitendinosus (ST)	6.31 percentage of MVC Standard Error 1.97
EMG During vibration semitendinosus (ST)	6.64 percentage of MVC Standard Error 0.95
EMG Baseline deltoideus medius	1.23 percentage of MVC Standard Error 0.13
EMG During vibration deltoideus medius	4.25 percentage of MVC Standard Error 1.05

Adverse Events

Healthy Volunteers (1st Iteration of Device Development)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Healthy Volunteers (1st Iteration of Device Development) n=22 participants at risk This phase recruited healthy volunteers who were vibrated with the prototype device using various vibration frequencies to determine which frequency produces the optimal physiologic response. Physiologic responses were determined with a number of devices capable of measuring such things as tissue oxygenation, oxygen consumption, and muscle activity. Volunteers were randomized to receive alternating 5 minute episodes of various vibration frequencies. Therapeutic Vibration Device: The Therapeutic Vibration Device is capable of applying force through the axial skeletal spine, through bidirectional compression loading (or prestressing) between the shoulder and the plantar surfaces of the feet. It is placed around the body like a mobile frame so that the applied vibration can affect the whole body. The vibration actuators (drivers) are mobile and can vary in size, frequency response, and force. The design minimizes the possibility of mechanical interference for ventilated/intubated patients.
General disorders Discomfort	13.6% 3/22 • AEs were collected only on the days of testing for occurrences during testing sessions. Testing sessions lasted 2-3 hours and the maximum time between first and last session was 146 days, though a more typical spread was 35 days. (Sessions were held at the participant's convenience.)

Additional Information

Dr. Benjamin Bassin

Unversity of Michigan

Phone: 734 763-2134

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place