Parkinson's Disease (PD)NCT06932679
Perception of Affordances and Obstacle Crossing in People With Parkinson's Disease and Healthy Adults
An observational study of Parkinson's Disease (PD), run by University of Haifa at 1 site in Israel.
Trial summary
This study aims to explore how young adults, older adults and people with Parkinson's disease (PwP), perceive their abilty to cross obstacles while walking, and how this perception is related to their actual performance of obstacle crossing and disease-related motor and cognitive impairments. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- Assessment of Gait and Visual Exploration
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Apr 2025to 24 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
University of Haifa, Motor Performance Laboratory
Haifa, 3103301
Galit Yogev Seligmann, PhD, +972-53-5315761, galit.yogev@gmail.com
Michal Kafri, PhD, +972-58-6862261, kafri.michal@gmail.com
About this study
Official title: Affordances and Impairments: A Paradigm for Understanding Obstacle Crossing in Parkinson's Disease
This study aims to explore how young adults, older adults and people with Parkinson's disease (PwP), perceive their abilty to cross obstacles while walking, and how this perception is related to their actual performance of obstacle crossing and disease-related motor and cognitive impairments. The study will explore this percepeption and the actual performance in different walking environments(floor, synthetic grass turf). Understanding how people perceive obstacles may help improve rehabilitation methods and reduce the risk of falls. The study will take place at the Motor Performance Laboratory, University of Haifa, and will include walking tasks, eye-tracking measurements, and motor and cognitive assessments.
Read the 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.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- Assessment of Gait and Visual Exploration
- Keywords
- Parkinson's Disease, Obstacle Crossing, Gait, Affordances, Motor Control, Balance, Fall Risk, Visual Exploration, Gaze Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Gait and Visual ExplorationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease | Participants diagnosed with Parkinson's disease (PwP), aged 60-80 years, able to walk independently outdoors. Receives: Other: Assessment of Gait and Visual Exploration | |
| Healthy Older Adults | Healthy adults aged 60-80 years, without neurological or orthopedic conditions affecting gait. Receives: Other: Assessment of Gait and Visual Exploration | |
| Healthy Young Adults | Healthy adults aged 20-30 years, without neurological or orthopedic conditions affecting gait. Receives: Other: Assessment of Gait and Visual Exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affordance Perception Accuracy
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.
Measured: During single laboratory session (about 3 hours)
Affordances measured by gaze behavior
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).
Measured: During a single laboratory session (approximately 3 hours)
Secondary outcomes (5)
Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
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.
Measured: During a single laboratory session (approximately 3 hours)
Walking Speed
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.
Measured: During a single laboratory session (approximately 3 hours)
Step Length
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.
Measured: During a single laboratory session (approximately 3 hours)
Levodopa Equivalent Daily Dose (LEDD)
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.
Measured: During a single laboratory session (approximately 3 hours)
Cognitive Performance - Stroop Test (NeuroTrax Cognitive Battery)
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.
Measured: During a single laboratory session (approximately 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start24 Apr 2025
- Primary completion24 Apr 2028 (estimated)
- Study completion24 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galit Yogev-Seligmann, University of Haifa
- Investigators
- Galit Yogev Seligmann, PhD, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932679
- Sponsor's protocol ID
- 1561/25
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. Data collected in this study will only be used by the study investigators for research purposes, in accordance with the approved study protocol and ethical guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affordances and Impairments: A Paradigm for Understanding Obstacle Crossing in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06932679
- Acronym / sponsor ID
- 1561/25
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Parkinson's Disease, Obstacle Crossing, Gait, Affordances, Motor Control, Balance, Fall Risk, Visual Exploration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 24 Apr 2028 (estimated)
- Study completion
- 24 Jun 2028 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore how young adults, older adults and people with Parkinson's disease (PwP), perceive their abilty to cross obstacles while walking, and how this perception is related to their actual performance of obstacle crossing and disease-related motor and cognitive impairments. The study will explore this percepeption and the actual performance in different walking environments(floor, synthetic grass turf). Understanding how people perceive obstacles may help improve rehabilitation methods and reduce the risk of falls. The study will take place at the Motor Performance Laboratory, University of Haifa, and will include walking tasks, eye-tracking measurements, and motor and cognitive assessments.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease | – | Other: Assessment of Gait and Visual ExplorationParticipants diagnosed with Parkinson's disease (PwP), aged 60-80 years, able to walk independently outdoors. |
| Healthy Older Adults | – | Other: Assessment of Gait and Visual ExplorationHealthy adults aged 60-80 years, without neurological or orthopedic conditions affecting gait. |
| Healthy Young Adults | – | Other: Assessment of Gait and Visual ExplorationHealthy adults aged 20-30 years, without neurological or orthopedic conditions affecting gait. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of Gait and Visual ExplorationParticipants 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. | Other | Healthy Older Adults, Healthy Young Adults, Parkinson's Disease |
Primary outcome
Affordance Perception Accuracy
Time frame: During single laboratory session (about 3 hours)
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.
Affordances measured by gaze behavior
Time frame: During a single laboratory session (approximately 3 hours)
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).
5 secondary outcomes
Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: During a single laboratory session (approximately 3 hours)
Walking Speed
Time frame: During a single laboratory session (approximately 3 hours)
Step Length
Time frame: During a single laboratory session (approximately 3 hours)
Levodopa Equivalent Daily Dose (LEDD)
Time frame: During a single laboratory session (approximately 3 hours)
Cognitive Performance - Stroop Test (NeuroTrax Cognitive Battery)
Time frame: During a single laboratory session (approximately 3 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. Data collected in this study will only be used by the study investigators for research purposes, in accordance with the approved study protocol and ethical guidelines.
Related trials for Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Recruiting
Prevention-in-PD-Study
Parkinson's Disease (PD)
Recruiting
Effect of Physical Activity on the Course of Parkinson's Disease in Patients With Bilateral DBS-STN Stimulation.
Parkinson Disease, Deep Brain Stimulation
RecruitingPhase 2
RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
Adjustment Disorder
Not yet recruiting
Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease
Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Galit Yogev Seligmann, PhD principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease (PD), run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Galit Yogev Seligmann, PhD (+972-53-5315761, galit.yogev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affordance Perception Accuracy (time frame: During single laboratory session (about 3 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.