Testing of a New Therapeutic Vibration Device to Reduce Neuromuscular Weakness in Hospitalized Patients
Primary Purpose
Critically Ill, Post Intensive Care Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapeutic Vibration Device
Sponsored by
About this trial
This is an interventional prevention trial for Critically Ill
Eligibility Criteria
Exclusion Criteria:
- Known pregnancy
- Prisoner
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Healthy volunteers (iterative device development)
Arm Description
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.
Outcomes
Primary Outcome Measures
StO2
1) Tissue hemoglobin oxygen saturation (StO2) using near infrared spectroscopy of the thighs, biceps, and brain.
VO2
Oxygen consumption using a VO2 monitor and mask
EMG
Muscle contraction using noninvasive electromyography
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03479008
Brief Title
Testing of a New Therapeutic Vibration Device to Reduce Neuromuscular Weakness in Hospitalized Patients
Official Title
Testing of a New Therapeutic Vibration Device to Reduce Neuromuscular Weakness in Hospitalized Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill, Post Intensive Care Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers (iterative device development)
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Therapeutic Vibration Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
StO2
Description
1) Tissue hemoglobin oxygen saturation (StO2) using near infrared spectroscopy of the thighs, biceps, and brain.
Time Frame
2 hours
Title
VO2
Description
Oxygen consumption using a VO2 monitor and mask
Time Frame
2 hours
Title
EMG
Description
Muscle contraction using noninvasive electromyography
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Exclusion Criteria:
Known pregnancy
Prisoner
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin L Bisco, BA
Phone
(734) 936-5947
Email
biscoe@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin S Bassin, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin L Bisco, BA
Phone
734-936-5947
Email
biscoe@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Benjamin S Bassin, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34036017
Citation
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.
Results Reference
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Testing of a New Therapeutic Vibration Device to Reduce Neuromuscular Weakness in Hospitalized Patients
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