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Parkinson's Disease (PD)NCT07540325

Effects of Cognitive Dual-Task on Gait in Parkinson's Disease

An observational study of Parkinson's Disease (PD) and Cognition, run by Gazi University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The aim of this study is to evaluate gait in individuals diagnosed with PD under tasks involving different cognitive domains, to compare the results with those of age and sex-matched healthy individuals, and to determine which cognitive function has the greatest impact on gait in PD. Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Apr 2026to 31 Dec 2026
How long will I take part?
2 Days
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 40 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population includes patients diagnosed with Parkinson's Disease who are followed up or treated at the Gazi University and age-matched healthy volunteers from the local community in Ankara.

Who may be able to join

  • Aged between 40 and 80 years
  • A score of at least 21 on the Montreal Cognitive Assessment (MoCA)

Who cannot join

  • Presence of any neurological disorder
  • Presence of any cardiopulmonary or musculoskeletal condition that may affect safe ambulation
  • A score of ≥10 for anxiety and ≥7 for depression on the Hospital Anxiety and Depression Scale (HADS)
  • Presence of visual or auditory impairments that cannot be corrected with assistive devices

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nisa Ceren YAVUZ contact

+90533 079 54 82

ynisaceren@gmail.com

Turkey (Türkiye)1 site
  • Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation.

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Investigating the Effects of Cognitive Dual-Task on Gait in Individuals With Parkinson's Disease

The aim of this study is to evaluate gait in individuals diagnosed with PD under tasks involving different cognitive domains, to compare the results with those of age and sex-matched healthy individuals, and to determine which cognitive function has the greatest impact on gait in PD.

Read the detailed description

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by the coexistence of motor and non-motor symptoms, which negatively affect individuals' activities of daily living and quality of life. Although motor symptoms are predominant in PD, impairments in cognitive functions are known to be present from the early stages of the disease and contribute to the clinical picture, thereby limiting functional abilities such as gait.

Cognitive functions play a critical role in the planning, initiation, and maintenance of gait. As one of the key determinants of independence, walking is often performed under cognitive load in daily life. The ability to perform motor and cognitive dual tasks simultaneously during walking requires effective attentional allocation and increased information processing speed, and the central nervous system is capable of adapting to these demands. However, in neurodegenerative diseases such as PD, the simultaneous execution of cognitive and motor tasks becomes more challenging, leading to difficulties in maintaining balance during gait and an increased risk of falls.

Cognition encompasses multiple domains, including memory, attention, executive functions, language, and visuospatial abilities. Although it is known that cognition affects gait performance in PD, the specific contributions of each cognitive domain to gait are not yet fully understood. Therefore, investigating the effects of cognitive tasks on gait performance in PD represents an important area of research.

It is anticipated that the findings of this study will contribute to the development of structured gait training programs aimed at improving functional independence in gait-related activities of daily living in individuals with PD. Furthermore, these findings are expected to support the development of effective and individualized strategies for fall prevention, which remains one of the major challenges in physiotherapy management of PD.

Keywords
Gait, Cognitive Function, Dual-Task, Parkinson's Disease
Medical subject headings
Parkinson Disease, Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07540325
Study groupRoleWhat they receive
Parkinson's Disease GroupThis group consists of individuals diagnosed with idiopathic Parkinson's Disease by a specialist neurologist according to the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria, with a disease severity between stages 1 and 3 according to the Modified Hoehn and Yahr Scale.
Healthy Control GroupThis group includes healthy volunteers with similar age, gender, and educational background to the Parkinson's Disease group, and who have no history of any neurological, psychiatric, or musculoskeletal disorders that could affect gait or cognitive performance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global Cognition Assessed by the Montreal Cognitive Assessment

    The assessment of cognitive functions will begin with the evaluation of global cognition. Global cognition will be evaluated using the Montreal Cognitive Assessment (MoCA). The Montreal Cognitive Assessment is a validated scale designed to assess multiple cognitive functions, including attention, concentration, executive functions, memory, language, visuospatial skills, abstract reasoning, calculation, and orientation. The instrument has a maximum total score of 30 points. According to the original validation study, scores of 26 and above are generally considered to represent normal cognitive function, whereas scores below 26 are reported to indicate potential cognitive impairment.

    For the purpose of this study, an inclusion criterion of a MoCA score ≥ 21 has been established.

    Measured: Day 1

  2. Language Function Assessed by the Boston Naming Test

    The short form of the Boston Naming Test (BNT), consisting of 15 items (BNT-15), will be used to assess language function. The test comprises images ranging from commonly recognized objects to those that are progressively more difficult to identify. Participants are asked to name the object depicted in each image. If the participant is unable to provide the correct name (e.g., "pelican"), semantic or phonemic cues (e.g., "it is a bird," "pe…") may be provided. The examiner records the type and number of cues required and whether they lead to a correct response. Each correct response is scored as 1 point. The maximum possible score is 15 points, with higher scores indicating better language performance.

    Measured: Day 1

  3. Memory Assessed by the Rey Auditory Verbal Learning Test

    The Rey Auditory Verbal Learning Test (RAVLT) will be used to assess memory. This test evaluates verbal learning, immediate verbal memory, susceptibility to interference, free recall, and recognition memory. Scoring is based on the number of correctly recalled words in each trial, delayed recall performance, and the number of correctly rejected distractor items during the recognition phase. Higher scores across all indices indicate superior verbal learning and memory capacity, while significant discrepancies between immediate and delayed recall may suggest retrieval or storage deficits.

    Measured: Day 1

  4. Visuospatial Function Assessed by the Benton Judgment of Line Orientation Test

    The Benton Judgment of Line Orientation Test (JLOT), will be used to assess visuospatial function. The primary aim of the test is to evaluate the individual's ability to perceive, organize, and relate elements within a visual stimulus according to their spatial orientation. The test consists of 30 items, and task difficulty increases progressively as the line segments are shortened from the top or bottom. Scoring is based on paired responses; a point is awarded only if both lines in a pair are correctly identified. Higher scores indicate superior visuospatial perception and spatial relation skills, whereas lower scores may reflect impairments in right-hemisphere mediated spatial organization.

    Measured: Day 1

  5. Executive Function Assessed by the Stroop Test (Çapa Version)

    The Stroop Test (Çapa Version) will be used to assess executive functions. This test evaluates selective attention, response inhibition, cognitive flexibility, and information processing speed. The test consists of two stimulus cards. The first card includes 60 colored rectangles (red, green, and blue) arranged in six rows of ten items each. The second card contains color words printed in incongruent ink colors in the same format. For each stage, completion time is recorded in seconds using a digital stopwatch, while the number of errors and self-corrections is recorded as counts. The "interference resistance" time (Stroop D) is calculated in seconds using the formula: Stroop D = Stroop C - Stroop B

    Measured: Day 1

  6. Attention Assessed by the Digit Span Test

    The Digit Span Test, a subtest of the Wechsler Memory Scale-Revised, is used to assess attention and concentration. It consists of two components: forward digit span and backward digit span, each associated with different cognitive processes. The scoring was determined by the longest sequence of digits correctly repeated in at least one of the two trials for each level. The maximum attainable span length was 7 for the forward condition and 6 for the backward condition. Based on established norms, the lower limits for normal function were defined as a span of 6 for forward and 4 for backward sequences. The difference between forward and backward digit span should not exceed two digits. Higher scores represent superior working memory and attentional performance.

    Measured: Day 1

  7. Analysis of Spatiotemporal Gait Parameters Under Dual-Task Conditions

    Spatiotemporal gait parameters and variability measures will be assessed using the SensorMedica FreeMed baropodometric platform. Within the scope of gait analysis, each participant will first be asked to walk at a self-selected comfortable speed without any dual-task condition, and baseline spatiotemporal parameters will be recorded. Subsequently, gait will be assessed under predefined cognitive dual-task conditions. In this study, participants will be instructed to walk continuously on the platform without stopping, completing at least 40 steps. To ensure a detailed gait analysis, the following parameters will be recorded and reported independently: Step length (cm), step width (cm), cadence (steps/min), step cycle duration (s), stance and swing phase durations (% of gait cycle), single and double support times (s), and gait variability (CV%). Multiple units will be reported for each specific gait sub-parameter as detailed in the description.

    Measured: Day 2

  8. Cognitive Dual-Task Gait Protocol

    This study evaluates gait performance under five cognitive dual-task conditions targeting language, memory, attention, visuospatial, and executive functions in Parkinson's disease (PD). Tasks were developed based on standardized neuropsychological tests, including the Boston Naming Test, Rey Auditory Verbal Learning Test, Benton Judgment of Line Orientation, Digit Span, MoCA, and Stroop Test. Participants walk at a self-selected pace on a gait platform under seven conditions: single-task, five cognitive dual-tasks, and a motor dual-task. In the single-task condition, participants walk at a comfortable speed. Language tasks involve naming images; memory tasks require recalling word lists; visuospatial tasks involve identifying line orientations; executive tasks require naming ink color of incongruent words; attention tasks involve repeating digit sequences. In the motor task, participants walk while carrying a glass of water.

    Measured: Day 2

Secondary outcomes (4)
  1. Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III: Motor Examination (MDS-UPDRS III)

    The severity of motor symptoms in patients with Parkinson's disease (PD) will be assessed using Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS consists of four parts. Part I evaluates non-motor experiences of daily living with 13 items, while Part II assesses motor experiences of daily living, also consisting of 13 items. Part III focuses on motor examination and includes 18 items assessing motor symptoms. Part IV consists of 6 items evaluating motor complications related to treatment. Each item in the scale is scored on a 5-point Likert scale ranging from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. In this study, Parts I, III, and IV will be used to obtain descriptive clinical data for individuals with PD.

    Measured: Day 1

  2. Anxiety and Depression Assessed by the Hospital Anxiety and Depression Scale

    Since anxiety and mood status may influence gait performance, these factors will be evaluated. For this purpose, the Hospital Anxiety and Depression Scale (HADS) will be used. The HADS consists of 14 items and includes two subscales: anxiety (HADS-A) and depression (HADS-D). Each subscale yields scores ranging from 0 to 21. The cut-off points for the Turkish version are 10 for the anxiety subscale (HADS-A) and 7 for the depression subscale (HADS-D).

    Measured: Day 1

  3. Static Balance Assessed by the SensorMedica FreeMed Device

    Static balance analysis will be performed using the SensorMedica FreeMed (FreeMed, SensorMedica, Rome, Italy) device. The system will be calibrated prior to each assessment. Before testing, participants will be informed about the test procedures. All assessments will be conducted with participants barefoot. Prior to the measurements, participants will be instructed to stand upright, look at a fixed point in front of them, and distribute their body weight evenly on both feet in order to align their center of mass along the midline. For this purpose, participants will be asked to position the point representing their center of pressure, displayed on the device screen, within the marked central cross area on the platform. During the tests, participants will be instructed not to lift or move their feet. Measurements will be performed twice under both eyes-open and eyes-closed conditions, and the mean values will be used for analysis.

    Measured: Day 2

  4. Dual-Task Cost

    An individual's capacity to perform a dual task is defined as dual-task performance. To determine the impact of dual-task conditions on performance, dual-task cost is calculated using measures such as task accuracy and the time required to complete the dual task. Dual-task cost is expressed using the following formula: Dual-Task Cost = [(Dual-Task Performance - Single-Task Performance) / Single-Task Performance] × 100

    Measured: Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2026
  2. Study start20 Apr 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
30 participants (estimated)
Target duration
2 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07540325
Sponsor's protocol ID
2026 - 415
Status last verified
Apr 2026
First submitted
24 Mar 2026
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Penko AL, Streicher MC, Koop MM, Dey T, Rosenfeldt AB, Bazyk AS, Alberts JL. Dual-task Interference Disrupts Parkinson's Gait Across Multiple Cognitive Domains. Neuroscience. 2018 May 21;379:375-382. doi: 10.1016/j.neuroscience.2018.03.021. Epub 2018 Mar 22.

    PubMed 29577998

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease (PD) and Cognition, run by Gazi University at 1 site in Turkey (Türkiye).

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 2 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 20 Apr 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 Turkey (Türkiye). 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 Nisa Ceren YAVUZ (+90533 079 54 82, ynisaceren@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Cognition Assessed by the Montreal Cognitive Assessment (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07540325, which also lists 1 linked publication.

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 20 Apr 2026.

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