Recruiting · registry statusUsing touch cues to make walking more automatic
Researchers study personalised touch signals timed to steps, examining walking and brain activity in Parkinson’s.
Testing a treatment or activity · Study reference: NCT05818189
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
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- Start (reported actual date)
- 2025-01-15
- Main measurements finished (planned)
- 2027-10-01
- Study finished (planned)
- 2028-01-31
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Who can join?
Ages 45 years to 85 years · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
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).
Full study name & original research details
Official study title
Cortical Correlates of Gait in Parkinson's Disease: Impact of Medication and Cueing
Original description
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.
Further description from the registry
Cortical correlates of gait automaticity in Parkinson's disease: impact of cueing
A well-recognized hallmark of healthy walking is automaticity, defined as the ability of the nervous system to successfully coordinate movement with minimal use of attention-demanding, executive resources. It has been proposed that many walking abnormalities in people with Parkinson's disease (PD) are characterized by a shift in locomotor control from healthy automaticity to compensatory, executive control. This shift to less automaticity is potentially detrimental to walking performance as executive control strategies are not optimized for locomotor control, place excessive demands on a limited cognitive reserve, and continuously require attention. It has been hypothesized that as gait becomes more variable, as in people with Parkinson's Disease, control of gait is less automatic, i.e., requires more prefrontal cortex involvement. However, as gait variability is not a direct measure of automaticity, it is controversial whether it truly reflects impaired gait automaticity or impaired gait stability (i.e., dynamic balance). The recent development of wireless, functional, near-infrared spectroscopy (fNIRS) of the brain provides more direct, physiological measures of automaticity, such as reduced prefrontal cortex activity. However, the contribution of other cortical areas to the concept of gait automaticity is largely unknown. Here, for the first time, the researchers will use a full cap fNIRS system to monitor cortical activity in multiple brain areas and wearable, inertial sensors to determine how cognitive abilities, levodopa, and cueing influence gait automaticity.
The effects of cognitive dysfunction and interventions on gait in people with Parkinson's Disease are complex. Impaired executive function has been associated with impaired gait and balance in PD, but it is not known if this relationship is due to the inability to compensate for poor basal ganglia control of gait automaticity with increased prefrontal cortex activity while walking. Sensory cueing may increase gait speed and reduce prefrontal activity but unlike levodopa, it may result in reduced gait variability due to enhanced automaticity. The researchers recently developed a novel type of personalized (triggered by the subject's own walking pattern), step-synchronized tactile stimulation on the wrists to improve the quality of gait and turning in people with Parkinson's Disease. The researchers will now compare the effects of cognitive dysfunction, dopaminergic medication, and tactile cueing on the quality of gait and turning and investigate whether improvements reflect changes in prefrontal activity.
This project will characterize the cortical correlates of gait automaticity, the changes in gait automaticity with cueing in people with PD, 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.
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). We 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. A secondary analysis will explore whether the effect of cueing on gait automaticity is influenced by cognitive dysfunction. In addition, we will explore the feasibility and potential benefits of independent use of tactile cueing during a week in daily life for a future clinical trial. We will explore feasibility and efficacy of cueing in daily life comparing data of gait and turning from a week of continuous monitoring without and with using the tactile cueing. In addition, we will test whether any retention on gait and turning is present by adding a third week of continuous monitoring.
Conditions reported: Parkinson Disease
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- Personalized tactile cueing; Fixed tactile cueing
- Phases
- NA
- Sponsor
- Oregon Health and Science University
- Start date reported by registry
- 2025-01-15 (actual)
Registry updated: 2025-12-17 · Status last verified by the registry submitter: 2025-12
Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Francesa Alcalá, B.S. · 503-913-3691 · alcalaf@ohsu.edu
Graham Harker, MPH · 503-418-2601 · harkerh@ohsu.edu
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
Oregon Health and Science University
Portland, Oregon, United States
RecruitingFrancesca Alcalá, B.S. · 503-913-3691 · alcalaf@ohsu.edu
Graham Harker, MPH · 503-418-2601 · harkerg@ohsu.edu
Martina Mancini, PhD
Facility not reported
United States
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.