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Clinical Trials/NCT03907007
NCT03907007
Completed
Not Applicable

Effect of Auricular Stimulation on Locomotion in Patients With Parkinson's Disease

Inventram1 site in 1 country10 target enrollmentDecember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Inventram
Enrollment
10
Locations
1
Primary Endpoint
Stride length [m]
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The effect of auricular stimulation on the locomotion capability in patients with Parkinson's Disease was investigated.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
May 1, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Inventram
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of Parkinson's Disease
  • H\&Y Stage \>= 1
  • Existing bradykinesia symptoms
  • Existence of one of the symptoms below
  • Resting Tremor
  • 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

Outcomes

Primary Outcomes

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: 60 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

Stance Phase Percentage during walking [%]

Time Frame: Time Frame: 60 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

Swing Phase Percentage during walking [%]

Time Frame: Time Frame: 60 minutes after stimulation is initiated

Measurement through motion capture system

Study Sites (1)

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