Testing of a New Therapeutic Vibration Device to Reduce Neuromuscular Weakness in Hospitalized Patients

NCT03479008 | Completed Results FDA Device

• 1 other identifier: HUM00129402
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Test the ability of vibration to produce physiologic, biochemical, and anatomic changes consistent with exercise that would help prevent the development of muscle weakness that occurs when patients are immobile for long periods of time.

Conditions

Critically Ill; Post Intensive Care Syndrome

Outcome Measures

Primary Outcomes (6)

• Change in Regional Hemoglobin Oxygen Saturation

  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.

  10 minutes

• VO2 and VCO2

  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.

  baseline and during device use (10 minutes)

• Energy Expenditure

  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.

  10 minutes

• Minute Variation

  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.

  10 minutes

• Tidal Volume

  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.

  10 minutes

• EMG

  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.

  baseline and during intervention (not exceeding 1 minute)

Study Arms (1)

Healthy volunteers (iterative device development)

OTHER

This phase will recruit healthy volunteers who will be vibrated with the prototype device using various vibration frequencies to determine which frequency produces the optimal physiologic response. Physiologic responses will be determined with a number of devices capable of measuring such things as tissue oxygenation, oxygen consumption, and muscle activity. Volunteers will be randomized to receive alternating 5 minute episodes of various vibration frequencies.

Diagnostic Test: Therapeutic Vibration Device

Interventions

Therapeutic Vibration Device DIAGNOSTIC_TEST

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.

Healthy volunteers (iterative device development)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Known pregnancy
• Prisoner

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Saxena H, Ward KR, Krishnan C, Epureanu BI. Effect of Multi-Frequency Whole-Body Vibration on Muscle Activation, Metabolic Cost and Regional Tissue Oxygenation. IEEE Access. 2020;8:140445-140455. doi: 10.1109/access.2020.3011691. Epub 2020 Jul 24.

  PMID: 34036017 BACKGROUND

MeSH Terms

Conditions

Critical Illness; postintensive care syndrome

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

One cannot extrapolate the results of this study to patients at risk for PICS from prolonged immobilization. Study participants were healthy and led relatively active lifestyles. Critically ill and injured patients who are immobilized might not realize physiologic responses similar to or greater than those of this cohort. This study doesn't show whether the degree of muscle activation changes observed with WBV would act as a significant mitigator of atrophy.

Results Point of Contact

• Title: Dr. Benjamin Bassin
• Organization: Unversity of Michigan

bsbassin@med.umich.edu

734 763-2134

Study Officials

• Benjamin S Bassin, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in the Department of Emergency Medicine

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 27, 2018
• Study Start: March 26, 2018
• Primary Completion: March 22, 2019
• Study Completion: March 22, 2019
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)