- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06932679
Perception of Affordances and Obstacle Crossing in People With Parkinson's Disease and Healthy Adults
Affordances and Impairments: A Paradigm for Understanding Obstacle Crossing in Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study investigates the role of affordance perception - the ability to perceive opportunities for action - during obstacle crossing in people with Parkinson's disease (PwP). Falls are highly prevalent in PwP, often resulting from tripping over obstacles. While previous research has mainly focused on gait impairments, this study uniquely examines the perceptual stage that precedes movement and the association between perception, cognition, and motor performance.
Participants will include 60 PwP and 120 healthy adults (60 older adults and 60 young adults). All participants will perform walking tasks involving obstacle crossing under different environmental conditions (e.g., different obstacle heights and surfaces). Prior to walking, participants will judge whether they can safely cross the obstacle. Eye-tracking glasses will measure visual exploration patterns to assess how participants scan the environment. Additionally, walking variables such as speed and step length, will be recorded using wearable sensors.
The study will explore:
- Differences in affordance perception between PwP and healthy adults.
- Associations between motor and cognitive impairments and affordance perception in PwP.
- How affordance perception relates to gait performance during obstacle crossing.
Results from this study may help to develop new intervention strategies aimed at improving safe walking and obstacle negotiation in PwP.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Galit Yogev Seligmann, PhD
- Phone Number: +972-53-5315761
- Email: galit.yogev@gmail.com
Study Contact Backup
- Name: Michal Kafri, PhD
- Phone Number: +972-58-6862261
- Email: kafri.michal@gmail.com
Study Locations
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Haifa, Israel, 3103301
- Recruiting
- University of Haifa, Motor Performance Laboratory
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Contact:
- Galit Yogev Seligmann, PhD
- Phone Number: +972-53-5315761
- Email: galit.yogev@gmail.com
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Contact:
- Michal Kafri, PhD
- Phone Number: +972-58-6862261
- Email: kafri.michal@gmail.com
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Principal Investigator:
- Galit Yogev Seligmann, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population will include three groups: (1) people with Parkinson's disease (PwP), aged 60-80 years, diagnosed by a physician and able to walk independently outdoors; (2) healthy older adults aged 60-80 years without neurological or orthopedic conditions affecting gait; and (3) healthy young adults aged 20-30 years without neurological or orthopedic conditions affecting gait.
Participants will be recruited from the community, from clinical settings (for PwP), and through university-based recruitment systems (for young healthy adults).
Description
Inclusion Criteria:
- Participants aged 20 to 80 years.
- Ability to walk independently outdoors without assistive devices.
- For Parkinson's Disease (PD) group: Diagnosis of PD confirmed by medical records.
- For healthy control groups: No neurological or orthopedic conditions affecting gait.
Exclusion Criteria:
- Feezing of gait (for PD group only), based on a score greater than 0 on the Freezing of Gait Questionnaire.
- Severe visual impairment that cannot be corrected with glasses or lenses.
- Cognitive impairment, defined as a score below 18 on the telephone-based Mini-Mental State Examination (MMSE).
- Any orthopedic condition, pain, or other medical condition that may affect walking, based on self-report.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Parkinson's Disease
Participants diagnosed with Parkinson's disease (PwP), aged 60-80 years, able to walk independently outdoors.
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Participants will perform walking tasks involving obstacle crossing while their gait and visual exploration patterns are recorded using wearable sensors and eye-tracking glasses.
This is a non-invasive observational study with no therapeutic intervention.
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Healthy Older Adults
Healthy adults aged 60-80 years, without neurological or orthopedic conditions affecting gait.
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Participants will perform walking tasks involving obstacle crossing while their gait and visual exploration patterns are recorded using wearable sensors and eye-tracking glasses.
This is a non-invasive observational study with no therapeutic intervention.
|
|
Healthy Young Adults
Healthy adults aged 20-30 years, without neurological or orthopedic conditions affecting gait.
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Participants will perform walking tasks involving obstacle crossing while their gait and visual exploration patterns are recorded using wearable sensors and eye-tracking glasses.
This is a non-invasive observational study with no therapeutic intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Affordance Perception Accuracy
Time Frame: During single laboratory session (about 3 hours)
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Accuracy of participants' perception of their ability to cross obstacles of varying height and surface conditions.
Participants will judge whether they can safely cross an obstacle prior to walking.
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During single laboratory session (about 3 hours)
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Affordances measured by gaze behavior
Time Frame: During a single laboratory session (approximately 3 hours)
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Eye movement patterns during obstacle approach and crossing.
Gaze behavior will be recorded using wearable eye-tracking glasses (Tobii Pro Glasses 3) to assess visual exploration of the walking environment and obstacle.
Measures will include fixation(on obstacle) duration (milisecondes).
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During a single laboratory session (approximately 3 hours)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time Frame: During a single laboratory session (approximately 3 hours)
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Disease severity will be assessed using the MDS-UPDRS (Motor Examination).
This standardized clinical assessment measures motor symptoms in people with Parkinson's disease, including tremor, rigidity, bradykinesia, and postural stability.
Higher scores indicate greater motor impairment.
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During a single laboratory session (approximately 3 hours)
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Walking Speed
Time Frame: During a single laboratory session (approximately 3 hours)
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Walking speed during obstacle crossing tasks, measured using wearable sensors (APDM Mobility Lab).
Walking speed will be calculated in meters per second based on time and distance walked during the trials.
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During a single laboratory session (approximately 3 hours)
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Step Length
Time Frame: During a single laboratory session (approximately 3 hours)
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Step length during obstacle crossing tasks, measured using wearable sensors (APDM Mobility Lab).
Step length will be calculated in meters for each leg during walking trials, as an indicator of gait characteristics and stability.
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During a single laboratory session (approximately 3 hours)
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Levodopa Equivalent Daily Dose (LEDD)
Time Frame: During a single laboratory session (approximately 3 hours)
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The total daily dose of antiparkinsonian medications will be calculated for participants with Parkinson's disease using the standardized Levodopa Equivalent Daily Dose (LEDD) formula.
Higher values indicate greater medication use.
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During a single laboratory session (approximately 3 hours)
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Cognitive Performance - Stroop Test (NeuroTrax Cognitive Battery)
Time Frame: During a single laboratory session (approximately 3 hours)
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Cognitive function will be assessed using the computerized NeuroTrax Cognitive Battery.
Specifically, performance on the Stroop test will be used to evaluate executive function, focusing on response inhibition and attention control.
The Stroop test provides accuracy and reaction time scores, with higher scores reflecting better performance.
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During a single laboratory session (approximately 3 hours)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Galit Yogev Seligmann, PhD, University of Haifa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1561/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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