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

Critically Ill Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479008
• Other study ID #: HUM00129402
• Status: Completed
• Phase: N/A
• Start date: March 26, 2018
• Est. completion date: March 22, 2019

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 22, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Exclusion Criteria:

1. Known pregnancy

2. Prisoner

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Post Intensive Care Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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)