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Tactile Cueing for Parkinson's Disease (cueing Trial)
N/A
Recruiting
Led By Martina Mancini, PhD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Without musculoskeletal or peripheral or central nervous system disorders (other than PD) that could significantly affect their balance and gait
Hoehn & Yahr Levels II-III.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study the effects of a new tactile cueing system on walking in people with Parkinson's Disease. Researchers believe that the system will improve automaticity of walking and reduce brain activity in the
Who is the study for?
This trial is for people with Parkinson's Disease who can walk and follow instructions. They must be diagnosed by a specialist, not have other serious nervous system issues besides PD, and be at specific stages of the disease where symptoms are moderate.
What is being tested?
The study tests two types of tactile cueing systems to see if they help improve walking by making it more automatic and less reliant on thinking. One group gets cues synced with their steps; the other gets regular timed cues.
What are the potential side effects?
Since this trial involves non-invasive cueing techniques rather than medication, side effects may include discomfort from wearing the device or potential frustration if difficulties in using the system arise.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I don't have any nerve or muscle disorders affecting my balance or walking, other than Parkinson's disease.
Select...
My Parkinson's disease is at a moderate stage.
Select...
I have Parkinson's diagnosed by a specialist, with symptoms like slow movement, tremor, stiffness, or balance issues not caused by other conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Local Dynamic Stability
Parietal cortex activity
Prefrontal cortex activity
+3 moreSecondary study objectives
Gait speed
Gait speed variability
Number of steps during turning
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Personalized cueingExperimental Treatment1 Intervention
Personalized, step-synchronized tactile cueing, enhancing proprioceptive inputs, in the form of real-time, closed-loop tactile feedback signaling left and right stance times while walking
Group II: Fixed cueingActive Control1 Intervention
Tactile cueing at fixed intervals, enhancing proprioceptive inputs, in the form of open-loop tactile feedback (fixed rhythm) signaling left and right stance times while walking
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,747,647 Total Patients Enrolled
Oregon Health and Science UniversityLead Sponsor
1,008 Previous Clinical Trials
7,414,249 Total Patients Enrolled
14 Trials studying Dementia
1,564 Patients Enrolled for Dementia
Martina Mancini, PhDPrincipal InvestigatorOregon Health and Science University
2 Previous Clinical Trials
320 Total Patients Enrolled
Patty Carlson-Kuhta, PhDStudy ChairOregon Health and Science University