NCT06932679

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
26mo left

Started Apr 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Apr 2025Jun 2028

First Submitted

Initial submission to the registry

April 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

April 24, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2028

Last Updated

July 22, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

April 10, 2025

Last Update Submit

July 17, 2025

Conditions

Keywords

Parkinson's DiseaseObstacle CrossingGaitAffordancesMotor ControlBalanceFall RiskVisual ExplorationGaze Behavior

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    During a single laboratory session (approximately 3 hours)

Secondary Outcomes (5)

  • Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    During a single laboratory session (approximately 3 hours)

  • Walking Speed

    During a single laboratory session (approximately 3 hours)

  • Step Length

    During a single laboratory session (approximately 3 hours)

  • Levodopa Equivalent Daily Dose (LEDD)

    During a single laboratory session (approximately 3 hours)

  • Cognitive Performance - Stroop Test (NeuroTrax Cognitive Battery)

    During a single laboratory session (approximately 3 hours)

Study Arms (3)

Parkinson's Disease

Participants diagnosed with Parkinson's disease (PwP), aged 60-80 years, able to walk independently outdoors.

Other: Assessment of Gait and Visual Exploration

Healthy Older Adults

Healthy adults aged 60-80 years, without neurological or orthopedic conditions affecting gait.

Other: Assessment of Gait and Visual Exploration

Healthy Young Adults

Healthy adults aged 20-30 years, without neurological or orthopedic conditions affecting gait.

Other: Assessment of Gait and Visual Exploration

Interventions

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 Older AdultsHealthy Young AdultsParkinson's Disease

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Haifa, Motor Performance Laboratory

Haifa, 3103301, Israel

RECRUITING

Study Officials

  • Galit Yogev Seligmann, PhD

    University of Haifa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Galit Yogev Seligmann, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer, Department of Occupational Therapy, Faculty of Social Welfare and Health Sciences, University of Haifa

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 17, 2025

Study Start

April 24, 2025

Primary Completion (Estimated)

April 24, 2028

Study Completion (Estimated)

June 24, 2028

Last Updated

July 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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.

Locations