No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
45 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Oregon Health and Science University · Other
Who this trial is looking for
This trial is looking for people with Parkinson's disease to test a new cueing system that may help improve walking. Participants will be assigned to one of two groups to see how the cueing affects their walking ability.
Are You a Good Fit for This Trial?
Must not be takingDopamine-blocking agentsCholinesterase inhibitors
Rules you outProgressive supranuclear palsyMultiple system atrophyCorticobasal syndromeVascular parkinsonism
You may be able to join if
I have been diagnosed with Parkinson's disease.
I can follow directions for the study.
I can give my consent to participate.
I have mild to moderate symptoms (Hoehn & Yahr Levels II-III).
You may not be able to join if
I have severe movement issues that could affect study results.
I have a major medical condition affecting walking.
My cognitive assessment score is below 21.
I cannot stand or walk for 2 minutes without help.
I have Parkinson's plus syndromes or implanted electrodes.
I currently take medications that can affect my walking.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of the study is to determine the effects of a novel, personalized, tactile cueing system on gait automaticity. The researchers hypothesized that step-synchronized tactile cueing will reduce prefrontal cortex activity (improve automaticity) and improve gait variability (as well as gait speed). The researchers predict that improved automaticity with improved gait variability will be asso…
The purpose of the study is to determine the effects of a novel, personalized, tactile cueing system on gait automaticity. The researchers hypothesized that step-synchronized tactile cueing will reduce prefrontal cortex activity (improve automaticity) and improve gait variability (as well as gait speed). The researchers predict that improved automaticity with improved gait variability will be associated with increased activation of other than prefrontal cortical areas while walking (i.e., sensory-motor). To determine the effects of cueing, 60 participants with PD from will be randomized into one, of two, cueing interventions: 1) personalized, step-synchronized tactile cueing and 2) tactile cueing at fixed intervals as an active control group. In addition, the researchers will explore the feasibility and potential benefits of independent use of tactile cueing during a week in daily life for a future clinical trial.
This project will characterize the cortical correlates of gait automaticity, the changes in gait automaticity with cueing in people with Parkinson's Disease, and how these changes translate to improvement in gait and turning. The long-term goal is to unravel the mechanisms of impaired gait automaticity in Parkinson's Disease.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Diagnosis of idiopathic Parkinson's Disease from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with 1 or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive c…
Inclusion Criteria:
* Diagnosis of idiopathic Parkinson's Disease from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with 1 or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
* Without musculoskeletal or peripheral or central nervous system disorders (other than PD) that could significantly affect their balance and gait
* All subjects will be capable of following directions for the protocols and to give informed consent.
* Hoehn \& Yahr Levels II-III.
Exclusion Criteria:
* Severe dyskinesia that may affect quality of fNIRS.
* Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than Parkinson's Disease, significantly affecting gait and turning i.e., peripheral neuropathy with proprioceptive deficits (detected as lack of toe proprioception assessed during the neurological exam at Day 1), musculoskeletal disorders, vestibular problem, head injury, stroke.
* Montreal cognitive assessment (MoCA) score \< 21 or dementia that precludes consent to participate or ability to follow testing procedures
* Inability to stand or walk for 2 minutes without an assistive device.
* Idiopathic Parkinson's Disease exclusion criteria: Parkinson plus syndromes such as progressive supranuclear palsy, multiple system atrophy, or corticobasal syndrome or implanted electrodes for deep brain stimulation (DBS), possible vascular parkinsonism, current use of dopamine-blocking agents or cholinesterase inhibitor (as may affect Prefrontal cortical activity while walking).
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