Koc University Hospital
Istanbul, Turkey (Türkiye)
Completed
NCT Number: NCT03907007
Effect of Auricular Stimulation on Locomotion in Patients With Parkinson's Disease
The effect of auricular stimulation on the locomotion capability in patients with Parkinson's Disease was investigated.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Effect of the auricular stimulation as a supplementary and alternative usage to Levodopa was investigated in this study. Clinical data were collected through motion capture system while the participants performed the clinical task asked by the investigators.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Diagnosis of Parkinson's Disease
- H&Y Stage >= 1
- Existing bradykinesia symptoms
- Existence of one of the symptoms below
- Resting Tremor
- Rigidity
- Walking disorder
Exclusion criteria
- Cardiac Pacemaker
- Psychiatric diagnosis
- Irregular heart/respiration rate
- Pregnancy
- Alcohol consumption
- Cardiovascular disease history
- Wearing an electro-active prosthesis
- Brain surgery history
- Ongoing TENS/PENS therapy
Treatment and study plan
Percutaneous electrical nerve stimulation
DeviceStimulation and medication at the same instant
Other names: Stimulation & Medication
Primary outcomes
-
Stride length [m]
Time frame: Time Frame: Baseline
Measurement through motion capture system
-
Stride length [m]
Time frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
-
Stride length [m]
Time frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
-
Stride length [m]
Time frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
-
Stride velocity [m/s]
Time frame: Time Frame: Baseline
Measurement through motion capture system
-
Stride velocity [m/s]
Time frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
-
Stride velocity [m/s]
Time frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
-
Stride velocity [m/s]
Time frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
-
Turning Velocity [deg/s]
Time frame: Time Frame: Baseline
Measurement through motion capture system
-
Turning Velocity [deg/s]
Time frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
-
Turning Velocity [deg/s]
Time frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
-
Turning Velocity [deg/s]
Time frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
-
Double Support Percentage during walking [%]
Time frame: Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
Measurement through motion capture system
-
Double Support Percentage during walking [%]
Time frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
-
Double Support Percentage during walking [%]
Time frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
-
Double Support Percentage during walking [%]
Time frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
-
Swing Phase Percentage during walking [%]
Time frame: Time Frame: Baseline
Measurement through motion capture system
-
Swing Phase Percentage during walking [%]
Time frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
-
Swing Phase Percentage during walking [%]
Time frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
-
Swing Phase Percentage during walking [%]
Time frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
-
Stance Phase Percentage during walking [%]
Time frame: Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
Measurement through motion capture system
-
Stance Phase Percentage during walking [%]
Time frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
-
Stance Phase Percentage during walking [%]
Time frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
-
Stance Phase Percentage during walking [%]
Time frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
Sponsors and collaborators
Lead sponsor
Inventram
Industry
Collaborators
- Koç University
Registry information
Important dates
- Study start
- 2017
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Apr 8, 2019
- Registry last updated
- Mar 10, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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