NCT05106816

The Effects of Vibrotactile Stimulation in Patients With Movement Disorders

The Effects of Vibrotactile Stimulation (Not Impossible Vibrohealth) on Motor Control and Symptoms in Patients With Movement Disorders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Vibration applied to the skin has been anecdotally reported to potentially improve motor control in patients with movement disorders including Parkinson's disease, however few devices have been studied formally. In this study, the investigators will test the effect of skin surface vibration applied non-invasively to patients with movement disorders to determine if there are any beneficial effects on common tasks of motor control and/or abnormal motor symptoms in patients with Parkinson's disease (PD), essential tremor (ET), and dystonia.

Detailed description

This study is to evaluate the feasibility, reliability, and clinical effects of Non-invasive vibrotactile stimulation (VTS) on basic tasks of motor control and on the motor symptoms of patients with movement disorders. VTS Settings will include continuous stimulation, intermittent stimulation during walking, and sham stimulation. The investigators will recruit 30 patients with PD who are between the ages of 18-80 years old and independently living in the community. The investigators will additionally recruit up to 5 patients with ET and up to 5 patients with dystonia.

Conditions

• Parkinson Disease
• Essential Tremor
• Dystonia

Interventions

Type	Name	Description
OTHER	skin surface vibration	This study will use four vibrating devices worn on each of the limbs. The devices are paired with a cell phone application (to be used solely by research investigators) that adjusts the vibration settings. The intensity of the vibration produced by the device is far less than that produced by commercially available massagers used for relaxation using similar technology. The sensor in the device is a tri-axial accelerometer and gyroscope that measures position using the same technology as smartphones.
OTHER	light skin surface vibration- SHAM	This study will use four vibrating devices worn on each of the limbs. The devices are paired with a cell phone application (to be used solely by research investigators) that adjusts the vibration settings. The intensity of the vibration produced by the device is far less than that produced by commercially available massagers used for relaxation using similar technology. The sensor in the device is a tri-axial accelerometer and gyroscope that measures position using the same technology as smartphones. Worn at the lowest frequency will simulate the active arms with no potential change in symptoms.

Timeline

• Start date: 2021-10-07
• Primary completion: 2022-09-20
• Completion: 2022-09-20
• First posted: 2021-11-04
• Last updated: 2022-09-27

Locations

1 site across 1 country: United States