Effects of Cognitive Dual-Task on Gait in Parkinson's Disease
NCT07540325, Not yet recruiting, Gazi University
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of Cognitive Dual-Task on Gait in Parkinson's Disease | ClinicalTrials.gov |
| NCT number | NCT07540325 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Gazi University | ClinicalTrials.gov |
| Conditions | Parkinson's Disease (PD), Cognition, Gait Disorders | ClinicalTrials.gov |
| First posted | 2026-04-20 | ClinicalTrials.gov |
| Last updated | 2026-04-20 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Global Cognition Assessed by the Montreal Cognitive Assessment | Day 1 | 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. | ClinicalTrials.gov |
| Primary | Language Function Assessed by the Boston Naming Test | Day 1 | 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. | ClinicalTrials.gov |
| Primary | Memory Assessed by the Rey Auditory Verbal Learning Test | Day 1 | 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. | ClinicalTrials.gov |
| Primary | Visuospatial Function Assessed by the Benton Judgment of Line Orientation Test | Day 1 | 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. | ClinicalTrials.gov |
| Primary | Executive Function Assessed by the Stroop Test (Çapa Version) | Day 1 | 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 | ClinicalTrials.gov |
| Primary | Attention Assessed by the Digit Span Test | Day 1 | 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. | ClinicalTrials.gov |
| Primary | Analysis of Spatiotemporal Gait Parameters Under Dual-Task Conditions | Day 2 | 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. | ClinicalTrials.gov |
| Primary | Cognitive Dual-Task Gait Protocol | Day 2 | 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. | ClinicalTrials.gov |
| Secondary | Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III: Motor Examination (MDS-UPDRS III) | Day 1 | 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. | ClinicalTrials.gov |
| Secondary | Anxiety and Depression Assessed by the Hospital Anxiety and Depression Scale | Day 1 | 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). | ClinicalTrials.gov |
| Secondary | Static Balance Assessed by the SensorMedica FreeMed Device | Day 2 | 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. | ClinicalTrials.gov |
| Secondary | Dual-Task Cost | Day 2 | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 29577998 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Line Angle Matching | Primary outcome | ConductCognition |
| Picture Naming Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)