PARKINSON DISEASE (Disorder)NCT07907770
Perception of Action Opportunities for Obstacle Crossing in Parkinson's Disease
An observational study of PARKINSON DISEASE (Disorder) and Older Adults (65-85 Years), run by University of Haifa at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Older Adults (65-85 Years)
- What is being tested?
- Obstacle Crossing Task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2026to 1 Nov 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Community-dwelling older adults with and without Parkinson's disease, residing in the community
Who may be able to join
- Diagnosis of Parkinson's disease according to medical records.
- Ability to walk independently outdoors without walking aids in daily life.
- Fluent in reading and speaking Hebrew.
- Ability to walk independently outdoors without walking aids in daily life.
- Fluent in reading and speaking Hebrew.
- No diagnosis of Parkinson's disease or any other neurological condition.
Who cannot join
- Freezing of gait (Score > 0 on the NFOG-Q), for PD group only.
- Severe visual impairment that cannot be corrected with glasses (self-report).
- Dementia (Telephone Mini-Mental State Examination score ≤ 18).
- Any orthopaedic condition, pain, or health condition (other than PD) that affects walking (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
University of Haifa
Haifa, 3498838
Michal Kafri, PhD, +972586862261, kafri.michal@gmail.com
Galit Yogev-Seligman, PhD, +97248249973, galit.yogev@gmail.com
About this study
Official title: Perception of Action Opportunities for Obstacle Crossing in Individuals With Parkinson's Disease: Associations With Motor and Cognitive Impairments and Self-Awareness
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.
Read the detailed description
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).
- Being tested
- Obstacle Crossing Task
- Keywords
- Affordances, Obstacle crossing, Parkinson's disease, Cognitive, Self-awareness, Older adults, Scaling, Fall Risk, Motor
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstacle Crossing TaskBehavioural
The experimental task consists of 4 conditions:
- Estimation of maximum crossable obstacle height without a backpack.
- Estimation of maximum crossable obstacle height with a weighted backpack (approximately 10% of the participant's body weight).
- Actual physical crossing of the obstacle without a backpack.
- Actual physical crossing of the obstacle with a weighted backpack (approximately 10% of the participant's body weight).
| Study group | Role | What they receive |
|---|---|---|
| 1. Parkinson's Disease | Individuals diagnosed with Parkinson's disease, aged 65-85, capable of walking independently outdoors Receives: Behavioral: Obstacle Crossing Task | |
| 2. Healthy Controls | Healthy older adults, aged 65-85, without Parkinson's disease or other neurological conditions, capable of walking independently outdoors Receives: Behavioral: Obstacle Crossing Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Judgment error
Calculated as the absolute difference (in cm) between the estimated maximum obstacle height and the actual maximum height successfully crossed
Measured: 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
Measured: Baseline (single session, up to 2 hours)
Secondary outcomes (9)
1. Perceptual Error type (Over-estimation / Under-estimation)
Categorized as over-estimation (actual performance < estimated) or under-estimation (actual performance > estimated)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (single session, up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Maccabi Healthcare Services, Israel
- Responsible party
- Sponsor
- Investigators
- Michal Kafri, PhD, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907770
- Sponsor's protocol ID
- 449/26
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Action Opportunities for Obstacle Crossing in Individuals With Parkinson's Disease: Associations With Motor and Cognitive Impairments and Self-Awareness
- ClinicalTrials.gov ID
- NCT07907770
- Acronym / sponsor ID
- 449/26
- Keywords
- Affordances, Obstacle crossing, Parkinson's disease, Cognitive, Self-awareness, Older adults, Scaling, Fall Risk
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Maccabi Healthcare Services, Israel
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 30 Oct 2026 (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.
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.
Detailed description
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Parkinson's Disease | – | Behavioral: Obstacle Crossing TaskIndividuals diagnosed with Parkinson's disease, aged 65-85, capable of walking independently outdoors |
| 2. Healthy Controls | – | Behavioral: Obstacle Crossing TaskHealthy older adults, aged 65-85, without Parkinson's disease or other neurological conditions, capable of walking independently outdoors |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community-dwelling older adults with and without Parkinson's disease, residing in the community
Key inclusion criteria (6 listed)
- Diagnosis of Parkinson's disease according to medical records.
- Ability to walk independently outdoors without walking aids in daily life.
- Fluent in reading and speaking Hebrew.
- Ability to walk independently outdoors without walking aids in daily life.
- Fluent in reading and speaking Hebrew.
Key exclusion criteria (4 listed)
- Freezing of gait (Score > 0 on the NFOG-Q), for PD group only.
- Severe visual impairment that cannot be corrected with glasses (self-report).
- Dementia (Telephone Mini-Mental State Examination score ≤ 18).
- Any orthopaedic condition, pain, or health condition (other than PD) that affects walking (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 |
|---|---|---|
| Obstacle Crossing TaskThe 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). | Behavioural | 1. Parkinson's Disease, 2. Healthy Controls |
Primary outcome
1. Judgment error
Time frame: Baseline (single session, up to 2 hours)
Calculated as the absolute difference (in cm) between the estimated maximum obstacle height and the actual maximum height successfully crossed
2. Normalized Estimated Maximum Obstacle Crossing Height
Time frame: Baseline (single session, up to 2 hours)
The estimated maximum obstacle height the participant believes they can cross, normalized to the participant's leg length
9 secondary outcomes
1. Perceptual Error type (Over-estimation / Under-estimation)
Time frame: Baseline (single session, up to 2 hours)
2. Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Time frame: Baseline (single session, up to 2 hours)
3. Levodopa Equivalent Dose (LED)
Time frame: Baseline (single session, up to 2 hours)
4. Timed Up and Go (TUG) Test
Time frame: Baseline (single session, up to 2 hours)
5. NeuroTrax™ - Global Cognitive Score (GCS)
Time frame: Baseline (single session, up to 2 hours)
6. Self-Awareness of Falls Risk Measure (SAFRM)
Time frame: Baseline (single session, up to 2 hours)
7. Geriatric Depression Scale (GDS-15)
Time frame: Baseline (single session, up to 2 hours)
8. Activities-specific Balance Confidence (ABC) Scale
Time frame: Baseline (single session, up to 2 hours)
9. Charlson Comorbidity Index (CCI)
Time frame: Baseline (single session, up to 2 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 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for PARKINSON DISEASE (Disorder)
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Michal Kafri, 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 DISEASE (Disorder) and Older Adults (65-85 Years), 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 6 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: opening soon, as of the sponsor's last update on 30 Oct 2026. 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 Michal Kafri, PhD (+972586862261, kafri.michal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Judgment error (time frame: Baseline (single session, up to 2 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 30 Oct 2026.