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

NCT05352100 | Withdrawn FDA Device

• 1 other identifier: HUM00129402b
• Study Type: interventional
• Target: N/A
• 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

Outcome Measures

Primary Outcomes (9)

• StO2

  Tissue hemoglobin oxygen saturation (StO2) using near infrared spectroscopy of the thighs, biceps, and brain.

  2 hours

• VO2

  Oxygen consumption using a VO2 monitor and mask

  2 hours

• EMG

  Muscle contraction using noninvasive electromyography

  2 hours

• Blood markers - serum glucose

  Serum glucose (mg/dl)

  On the day of device use (1 day)

• Blood markers - lipids

  lipids (mg/dl)

  On the day of device use (1 day)

• Blood markers - cytokines

  inflammatory cytokines IL-6, TNFα, IL-1β (pg/ml)

  On the day of device use (1 day)

• Blood markers - growth hormone

  growth hormone (ng/ml)

  On the day of device use (1 day)

• Blood markers - cortisol

  cortisol (μg/dL)

  On the day of device use (1 day)

• bone turnover markers

  C-terminal telopeptide of type I collagen (CTX-I) and tartrate-resistant acid phosphatase 5b (U/L)

  On the day of device use (1 day)

Study Arms (1)

Hospitalized patients

EXPERIMENTAL

This phase will recruit hospitalized bedridden patients 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. Blood samples will also be taken to measure certain chemical markers associated with activity and increase blood flow. They may receive multiple 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.

Hospitalized patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• sick patients admitted to the ICUs at University of Michigan hospital

You may not qualify if:

• Acute Spinal Cord Injury
• Acute vertebral body fracture or injury
• Acute stroke or intracerebral hemorrhage
• Hemodynamic instability or other event/condition believed by care team to warrant nonparticipation
• Known pregnancy
• Prisoner

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

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

Study Officials

• Benjamin S Bassin, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• 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: April 22, 2022
• First Posted: April 28, 2022
• Study Start: November 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)