An observational study in PARKINSON DISEASE (Disorder) and Older Adults (65-85 Years), sponsored by University of Haifa. Not yet recruiting at 1 site in Israel. Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University of Haifa · Observational
The study examines how individuals with Parkinson's disease, compared to healthy older adults, evaluate their ability to cross an obstacle, and the association between this evaluation, motor and cognitive status, and self-awareness.
A total of 120 participants aged 65-85 years will be recruited: 60 with Parkinson's disease and 60 healthy adults. Following a telephone screening, eligible participants will be invited to a single session lasting 1.5 to 2 hours at the University of Haifa, a Maccabi Healthcare Services institute, or the participant's home.
During the session, following an explanation and the signing of an informed consent form, demographic and clinical data will be collected, anthropometric measurements will be taken, and questionnaires addressing walking confidence and emotional state will be completed. Furthermore, mobility will be assessed using the Timed Up and Go test, motor symptom severity will be assessed using the UPDRS-III (for individuals with Parkinson's disease only), and cognitive function will be evaluated via a computerized test. Finally, participants will perform the research task. In this task, while standing in front of the obstacle, they will be asked to estimate the maximum obstacle height they believe they can safely cross. Following this, they will be asked to actually cross it. Based on these data, the gap between perceived and actual ability will be calculated. The task will be performed under two conditions: without a backpack and with a weighted backpack (carrying approximately 10% of the participant's body weight). The performance of the research task will be video-recorded for the analysis of crossing data.
Background: Falls are a major cause of morbidity, loss of independence, and reduced quality of life in individuals with Parkinson's disease (PD). Crossing obstacles is a common daily task strongly associated with falls in this population. Before the physical movement of crossing occurs, individuals are involved in a perceptual phase in which they evaluate their capacity to perform the task (affordances). The accuracy of this perceptual estimation is critical: over-estimation can lead to falls, while under-estimation can unnecessarily limit independence. While literature shows healthy older adults tend to over-estimate their abilities in obstacle crossing, this has rarely been investigated in PD patients, who suffer from a unique combination of motor, cognitive, and self-awareness impairments. Furthermore, carrying an external object (such as a backpack) alters physical dimensions and further challenges this perceptual estimation, a common real-world scenario that may exacerbate the gap between perceived and actual ability.
Aims: The primary objective is to characterize the perception of action opportunities for obstacle crossing with and without a weighted backpack (carrying approximately 10% of the participant's body weight) in individuals with PD compared to healthy older adults. Secondary objectives include investigating the relationships between this perception and motor and cognitive status, and self-awareness.
Methods: The study is a cross-sectional observational study with experimental procedure. It involves a single meeting where participants will undergo a computerized cognitive assessment (NeuroTrax™), clinical motor tests (Timed Up and Go, MDS-UPDRS-III), and complete standardized questionnaires (NFOG-Q, SAFRM, GDS-15, ABC). The experimental task involves judging the maximum crossable height of an obstacle and then attempting to cross it, allowing for the calculation of the perceptual error and its type (over/under-estimation).
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 120 is above the median of 96 across 1,085 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Haifa is the lead sponsor of 105 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Community-dwelling older adults with and without Parkinson's disease, residing in the community
Inclusion Criteria (Parkinson's Disease Group):
Inclusion Criteria (Healthy Control Group):
Exclusion Criteria (Both Groups unless specified):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals diagnosed with Parkinson's disease, aged 65-85, capable of walking independently outdoors
Behavioral: Obstacle Crossing Task
Healthy older adults, aged 65-85, without Parkinson's disease or other neurological conditions, capable of walking independently outdoors
Behavioral: Obstacle Crossing Task
The experimental task consists of 4 conditions: 1. Estimation of maximum crossable obstacle height without a backpack. 2. Estimation of maximum crossable obstacle height with a weighted backpack (approximately 10% of the participant's body weight). 3. Actual physical crossing of the obstacle without a backpack. 4. Actual physical crossing of the obstacle with a weighted backpack (approximately 10% of the participant's body weight).
1. Judgment error
Calculated as the absolute difference (in cm) between the estimated maximum obstacle height and the actual maximum height successfully crossed
Time frame: Baseline (single session, up to 2 hours)
2. Normalized Estimated Maximum Obstacle Crossing Height
The estimated maximum obstacle height the participant believes they can cross, normalized to the participant's leg length
Time frame: Baseline (single session, up to 2 hours)
1. Perceptual Error type (Over-estimation / Under-estimation)
Categorized as over-estimation (actual performance \< estimated) or under-estimation (actual performance \> estimated)
Time frame: Baseline (single session, up to 2 hours)
2. Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
The evaluator assesses components such as bradykinesia, tremor, posture, and muscle rigidity. Higher scores indicate greater motor impairment. Assessed only in participants with Parkinson's disease
Time frame: Baseline (single session, up to 2 hours)
3. Levodopa Equivalent Dose (LED)
A calculated value reflecting the weighted medication dosage for Parkinson's disease, serving as an indicator of disease severity. Assessed only in the Parkinson's disease group.
Time frame: Baseline (single session, up to 2 hours)
4. Timed Up and Go (TUG) Test
The time (in seconds) it takes to rise from a chair, walk 3 meters, turn, return, and sit down is measured. Faster times indicate better functional mobility and lower fall risk
Time frame: Baseline (single session, up to 2 hours)
5. NeuroTrax™ - Global Cognitive Score (GCS)
Assessed using the NeuroTrax™ computerized cognitive testing battery. Participants perform tasks testing attention, visuospatial processing, and executive functions. Results yield a GCS, where higher scores indicate better cognitive function
Time frame: Baseline (single session, up to 2 hours)
6. Self-Awareness of Falls Risk Measure (SAFRM)
A measure assessing self-awareness of falls risk, consisting of identical patient and clinician versions across three sub-scales: Intellectual (15 items), Emergent (6 items, completed immediately after the Timed Up and Go test), and Anticipatory (10 items). The awareness score is calculated as the sum of the patient's scores minus the sum of the clinician's scores. A score of 0 indicates good awareness. A positive score indicates the patient overestimates their ability or underestimates the risk, while a negative score indicates the patient underestimates their ability or overestimates the risk
Time frame: Baseline (single session, up to 2 hours)
7. Geriatric Depression Scale (GDS-15)
A 15-item questionnaire. Scores range from 0 to 15, with scores greater than 5 indicating a probability of depression
Time frame: Baseline (single session, up to 2 hours)
8. Activities-specific Balance Confidence (ABC) Scale
Participants rate their confidence in performing daily activities without losing balance from 0% (no confidence) to 100% (complete confidence). The total score is the average of all items, with higher scores indicating greater confidence and less fear of falling
Time frame: Baseline (single session, up to 2 hours)
9. Charlson Comorbidity Index (CCI)
Quantified based on number and type of comorbidities as recorded in the participant's medical records. Higher scores indicate a heavier burden of comorbid conditions
Time frame: Baseline (single session, up to 2 hours)
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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