Status:
WITHDRAWN
Gait Disorders in Parkinson's Disease
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Background: Parkinson s disease (PD) is a neurologic disorder that causes slowness, tremor, rigidity, and imbalance. Gait impairment is also common. There are 2 substudies: (1) Physiology of Freezing...
Detailed Description
The objective of this protocol is to study the physiology of gait disorders in Parkinson s disease as well as to test the effect of non-invasive interventions on gait function in patients with Parkins...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 18 years or older
- Able to provide informed consent
- Clinical diagnosis of Parkinson disease by U.K. Parkinson Society Brain Bank Criteria
- Patients must be stage II -III on the Hoehn and Yahr scale
- EXCLUSION CRITERIA:
- MoCA\<25 within the last 6 months
- Uncontrolled medical condition requiring immediate treatment that would make a walking trial unsafe for the subject.
- Peripheral neuropathy that severely limits gait
- Current or recent orthopedic disorder that severely limits gait
- Current uncontrolled depression or major depressive episode
- Gait disorders other than PD.
- Cannot walk safely without corrective lenses and without support.
- Unable to abstain from PD medications overnight for at least 12 hours before testing
- History of deep brain stimulation surgery
- Subjects who are NINDS employees
- In addition to the preceding criteria, healthy volunteers must also have a normal neurological examination performed within the last year. Healthy volunteers will be healthy subjects without any major medical and neurological or psychiatric disorders established by history and physical/neurological examination. They will also have no gait disorders from any medical or surgical problems as per clinical assessment.
Exclusion
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03416452
Start Date
January 24 2018
End Date
November 13 2018
Last Update
November 20 2018
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