Effects of tactile cueing on walking in Parkinson's disease
Cortical Correlates of Gait in Parkinson's Disease: Impact of Medication and Cueing
This study is testing whether a special system that gives touch cues can help people with Parkinson's disease walk better and more smoothly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT05818189 on ClinicalTrials.gov |
What this trial studies
This study investigates how a personalized tactile cueing system affects gait automaticity in individuals with Parkinson's disease. Participants will be randomized into two groups: one receiving step-synchronized tactile cues and the other receiving fixed interval cues as a control. The researchers aim to measure changes in gait variability and speed, as well as cortical activity using functional near-infrared spectroscopy (fNIRS). The goal is to understand the relationship between cueing, gait performance, and brain activity, potentially leading to improved walking strategies for patients.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with idiopathic Parkinson's disease who exhibit bradykinesia and are capable of following study protocols.
Not a fit: Patients with severe dyskinesia or other significant neurological or musculoskeletal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance walking ability and quality of life for patients with Parkinson's disease by improving gait automaticity.
How similar studies have performed: While the approach of using tactile cueing is innovative, similar studies have shown promise in improving gait in Parkinson's disease, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 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).
Where this trial is running
Portland, Oregon
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Martina Mancini, PhD — Oregon Health and Science University
- Study coordinator: Francesa Alcalá, B.S.
- Email: alcalaf@ohsu.edu
- Phone: 503-913-3691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.