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

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.

Study Overview

• Status: Completed
• Conditions: Critically Ill; Post Intensive Care Syndrome
• Intervention / Treatment: Diagnostic test: Therapeutic Vibration Device

Detailed Description

During critical illness, patients who are immobilized for more than a few days develop severe muscle and nerve weakness despite receiving full supportive care, which may include physical therapy. In patients requiring mechanical ventilation (a device that breaths for them) for longer than 7 days, the incidence of ICU-acquired weakness is reported to be between 25% and 60%. Such weakness may contribute to increased duration of mechanical ventilation, increased length of stay in the ICU and hospital, and poor quality of life among survivors. This is part of the newly recognized Post Intensive Care Syndrome (PICS). Moreover, patients who are transferred from the ICU to a high-dependency unit (HDU), intensive therapy unit (ITU), post-operative therapy or outpatient ambulatory care need to be mobile as well as awake for any physical therapy. Patients affected by sepsis (severe blood stream infections), osteoarthritis, spinal cord injury, stroke, multiple sclerosis, cerebral palsy, cancer, and other illnesses suffer muscle loss and weakness. Early mobilization (EM) has demonstrated the ability to significantly reduce the detrimental effects of prolonged immobilization such as polyneuropathy and myopathy (nerve damage and muscle weakness), which in turn reduces the time patients spend on mechanical ventilation and the overall length of hospital stay. EM treatments include intense physical therapy, cycle ergometry, transcutaneous electrical muscle stimulation (TEMS) and continuous lateral rotational therapy (CLRT). However, carrying out intense physical therapy using therapists is impractical (especially at smaller hospitals) and cannot be implemented in heavily sedated patients (patients who cannot cooperate). Evidence suggests that vibration may be capable of producing adequate muscle contraction via muscle-spinal loops that may be sufficient to reduce or prevent nerve damage and muscle weakness caused by prolonged immobilization thus serving as an effective treatment making patients stronger when they leave the ICU.

The purpose of this study is to test a prototype vibration device and strategy on its ability to exercise large muscle groups, increase muscle blood flow, and increase circulating levels of blood chemicals associated with exercise/activity. The study will be used to find optimal vibration frequencies that provide maximal evidence of associated muscle activity. Eventually the investigators hope to see a vibration device capable of delivering a more effective therapy compared to the smaller gains derived from traditional measures of physical therapy in critically ill patients such as TEMS, CLRT and cycle ergometry to patients. The vibration device may directly benefit the patient in terms of health, length of stay and reduced re-admission, hospital staff in terms of productivity (i.e., through reduction in nursing effort) and the hospital in terms of reduced cost and return on investment. Its value is also envisioned in many other populations of immobilized acutely ill and injured patients as well as those with chronic conditions.

Originally registered as a single record, this registration has been simplified to clarify the outcomes measured from the work with healthy volunteers. A new registration which will include the relevant outcomes for the trial part that will enroll hospitalized participants will be registered prior to their enrollment. The current registration will remain open until it is certain that no additional modifications of the device are required to go through a new round of iterative testing with healthy volunteers. While the total number of participants to be enrolled is larger than some early feasibility trials, the testing is done in small iterative batches to determine whether additional design changes are required. Each of these is generally less than 10 individuals.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Exclusion Criteria:

1. Known pregnancy
2. Prisoner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Healthy volunteers (iterative device development); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Benjamin S Bassin, MD, University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2018
• Primary Completion (Actual): March 22, 2019
• Study Completion (Actual): March 22, 2019

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: HUM00129402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No