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

Therapuetic Areas:Other
Age Range:18 - Any
Start Date:March 26, 2018
End Date:March 2025
Contact:Amanda J Pennington, MS
Phone:(734) 936-5947

Use our guide to learn which trials are right for you!

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.

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.

Inclusion Criteria:

- healthy volunteers

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

Exclusion Criteria:

1. Acute Spinal Cord Injury

2. Acute vertebral body fracture or injury

3. Acute stroke or intracerebral hemorrhage

4. Hemodynamic instability or other event/condition believed by care team to warrant

5. Known pregnancy

6. Prisoner
We found this trial at
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Kevin E Ward, MD
Phone: 734-936-5947
University of Michigan The University of Michigan was founded in 1817 as one of the...
Ann Arbor, MI
Click here to add this to my saved trials