Vibrotactile Stimulation in Parkinson's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02933476|
Recruitment Status : Completed
First Posted : October 14, 2016
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Device: Vibrotactile Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vibrotactile Stimulation in Parkinson's Disease|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Experimental: Vibrotactile Stimulation Treatment
All patients will receive the vibrotactile stimulation treatment. No deception will be used.
Device: Vibrotactile Stimulation
The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device.
- Number of Patients Reporting Any Adverse Effects [ Time Frame: 1 Month ]Questionnaire asks patients to record any adverse effects they experienced.
- Unified Parkinson's Disease Rating Scale, Part III [ Time Frame: 1 Month ]We used the motor portion of the Unified Parkinson's disease Rating Scale (UPDRS) and excluded rigidity and speech from the assessment. Overall range of the score for the motor portion (excluding rigidity and speech) range from 0 to 108, where 0= best possible outcome and 108= worst possible outcome.
- Root Mean Square Velocity [ Time Frame: 1 Month ]Using gyroscopes to track patient movement testing, root mean square velocity (Vrms) of of the wrist during repetitive wrist flexion extension task was obtained.
- Gait Asymmetry [ Time Frame: 1 Month ]Using data collected from inertial measurement unit (IMU) sensors on subject, we were able to measure gait asymmetry. For each subject, the swing time (SW) was calculated and averaged across strides for the left and right legs (SWL and SWR). We obtained gait asymmetry using the following: 100 x /ln(SWR/SWL)/. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933476
|United States, California|
|Stanford Movement Disorders Clinic|
|Stanford, California, United States, 94304|
|Principal Investigator:||Helen Bronte-Stewart, MD, MS||Stanford University|