Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT07277205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Vestibular and Dual-Task Rehabilitation in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-30', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-11-30', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mini-BESTest Total Score', 'timeFrame': 'Baseline and Week 8', 'description': 'Dynamic balance will be assessed using the Mini-BESTest, consisting of 14 items scored from 0-2. The total score (0-28) will be used as the primary outcome, with higher scores indicating better balance and postural control.\n\nUnit of Measure: Points (0-28)'}, {'measure': 'Semantic Verbal Fluency Test (Semantic Fluency, 60 seconds)', 'timeFrame': 'Baseline and Week 8', 'description': 'Participants will name as many semantic-category words as possible within 60 seconds. The outcome will be the total number of correct words produced.\n\nUnit of Measure: Number of words'}], 'secondaryOutcomes': [{'measure': 'Digit Span Test (Forward and Backward)', 'timeFrame': 'Baseline and Week 8', 'description': 'Attention and working memory will be evaluated using the Digit Span Test. Numbers are read at one-per-second pace, and participants repeat increasingly longer sequences forward and backward. Outcome: maximum correctly recalled span for each condition.\n\nUnit of Measure: Digit span (number of digits)'}, {'measure': 'Clock Drawing Test (Manos & Wu Scoring Method)', 'timeFrame': 'Baseline and Week 8', 'description': 'Visuospatial and executive functions will be assessed by drawing "10 past 11" on a pre-segmented circle. Correct placement of 8 numbers and 2 clock hands are scored. Total score ranges from 0 to 10.\n\nUnit of Measure: Points (0-10)'}, {'measure': 'Four Square Step Test (FSST)', 'timeFrame': 'Baseline and Week 8', 'description': 'Participants step clockwise and counterclockwise through four squares following a fixed sequence. Time to complete the sequence is recorded. The best of two trials will be used.\n\nUnit of Measure: Seconds'}, {'measure': 'Dynamic Gait Index (DGI) Total Score', 'timeFrame': 'Baseline and Week 8', 'description': 'Dynamic balance during gait will be assessed using the Dynamic Gait Index. Eight items are scored from 0-3, with a maximum score of 24. Higher scores indicate better performance.\n\nUnit of Measure: Points (0-24)'}, {'measure': 'Postural Stability (KFORCE Plates - Center of Pressure Metrics)', 'timeFrame': 'Baseline and Week 8', 'description': 'Static and dynamic balance parameters (e.g., center-of-pressure displacement, sway, weight distribution) will be recorded using KFORCE force plates. Objective biomechanical data will be extracted from standardized stance and movement conditions.\n\nUnit of Measure: Center of pressure metrics (mm or mm/s)'}, {'measure': 'Parkinson Activity Scale (PAS) Total Score', 'timeFrame': 'Baseline and Week 8', 'description': 'Functional mobility and activity performance will be assessed using the Parkinson Activity Scale. Scores range from 0 to 4 for each item, with higher scores indicating better functional ability.\n\nUnit of Measure: Points'}, {'measure': "Parkinson's Disease Quality of Life Questionnaire (PDQ-39) Total Score", 'timeFrame': 'Baseline and Week 8', 'description': 'Quality of life will be measured with the PDQ-39, a 39-item questionnaire evaluating mobility, daily activities, emotional well-being, cognition, communication, and social functioning. Scores range 0-100, with higher scores indicating poorer quality of life.\n\nUnit of Measure: Total score (0-100)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Parkinson's disease (PD) is a long-term condition that affects movement, balance, and thinking abilities. It can cause tremor, stiffness, slow movements, and difficulty maintaining balance. In addition to these physical problems, many people with PD also experience difficulties with memory, attention, and other cognitive functions. The balance system in the inner ear (vestibular system) helps maintain posture and orientation, but this system may not work properly in people with PD.\n\nThis study aims to compare two different types of exercise programs to improve movement, balance, and cognitive abilities in individuals with PD. One program focuses on exercises that stimulate the balance system (vestibular rehabilitation), while the other combines thinking and movement activities at the same time (dual-task training).\n\nThirty-six people with PD will take part in the study. Participants will be randomly assigned to one of three groups: vestibular exercise group, dual-task exercise group, or control group. Exercises will be done under the supervision of a physiotherapist twice a week for eight weeks. Each session will last about 40 minutes and include activities that are safe, structured, and personalized.\n\nBefore and after the 8-week program, participants will complete simple tests that measure their memory, attention, walking ability, balance, and daily activity level. The results will show whether these exercise approaches can help improve both body and brain functions.\n\nThe findings of this study are expected to help physiotherapists design more effective and personalized rehabilitation programs for people with Parkinson's disease, leading to better balance, safer movement, and improved quality of life.", 'detailedDescription': "Parkinson's disease (PD) is a chronic, progressive neurodegenerative disorder characterized by motor symptoms such as tremor, rigidity, bradykinesia, and postural instability, as well as non-motor symptoms including cognitive impairment and depression. Postural control depends on the integration of visual, somatosensory, and vestibular inputs, and this multisensory integration is often impaired in PD. Vestibular dysfunction can manifest as dizziness, imbalance, and spatial disorientation, leading to functional limitations, an increased risk of falls, and reduced independence. Moreover, the vestibular system is anatomically and functionally connected to brain regions involved in cognition, such as the hippocampus and frontal cortex. Therefore, targeting vestibular function in rehabilitation may improve not only balance but also cognitive performance.\n\nPrevious research has demonstrated that vestibular rehabilitation can improve balance, gait, and postural stability in individuals with PD. However, its potential effects on cognitive functions have been largely neglected. In parallel, dual-task training-based on the simultaneous performance of motor and cognitive tasks-has emerged as an evidence-based approach to improve both motor and cognitive outcomes. Studies have shown that dual-task exercise can enhance gait speed, step length, balance, attention, and executive function in PD. Nevertheless, no studies have directly compared the effects of vestibular rehabilitation and dual-task exercise training on cognitive and motor functions in this population.\n\nThe present study is designed to fill this gap by comparing these two rehabilitation approaches. A total of 36 participants diagnosed with PD will be recruited and randomly assigned into three groups: (1) vestibular rehabilitation, (2) cognitive-motor dual-task training, and (3) control. Each intervention will be administered twice weekly for eight weeks, with each session lasting approximately 40 minutes under the supervision of a physiotherapist. The vestibular rehabilitation program will include static and dynamic balance training, gaze stabilization, adaptation, habituation, and substitution exercises. The dual-task training program will integrate functional balance exercises with concurrent cognitive challenges (e.g., counting backward, naming tasks, or alternating verbal tasks). The control group will maintain their usual level of physical activity.\n\nAssessments will be conducted before and after the 8-week intervention. Cognitive functions will be evaluated using the Digit Span Test, Word Fluency Test, and Clock Drawing Test. Motor functions will be assessed with the Mini-BESTest, Four Square Step Test, and Dynamic Gait Index, along with postural stability analysis using KFORCE Plates. Activity and participation will be evaluated using the Parkinson's Activity Scale and the Parkinson's Disease Questionnaire (PDQ-39).\n\nData will be analyzed using SPSS 21.0. Depending on normality assumptions, repeated-measures ANOVA or non-parametric alternatives will be used to assess within- and between-group differences. Statistical significance will be set at p \\< 0.05.\n\nThis study is expected to provide new insights into the clinical impact of vestibular and dual-task rehabilitation on cognitive and motor outcomes in PD. The results may contribute to developing individualized, evidence-based physiotherapy protocols that integrate balance and cognitive training, ultimately improving functional independence and quality of life among individuals with Parkinson's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged between 40 and 75 years\n* Diagnosed with idiopathic Parkinson\'s disease (IPD)\n* Stable medication regimen within the past one month\n* Hoehn and Yahr stage I-III\n* A score of at least 22 on the Montreal Cognitive Assessment (MoCA)\n* Participants evaluated during the "on" phase of their medication cycle\n* No hearing and/or visual impairments\n\nExclusion Criteria:\n\n* Presence of any neurological, cardiovascular, or orthopedic disorder that may interfere with walking\n* Diagnosis of any other neurological disease (e.g., dementia, cerebrovascular disease)\n* Patients with deep brain stimulation (DBS) implants\n* Presence of vascular pathologies in the lower extremities'}, 'identificationModule': {'nctId': 'NCT07277205', 'briefTitle': "Comparison of Vestibular and Dual-Task Rehabilitation in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': "Comparison of the Effects of Vestibular Rehabilitation and Dual-Task Exercise Programs on Cognitive and Motor Functions in Individuals With Parkinson's Disease", 'orgStudyIdInfo': {'id': '09.2025.304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vestibular Rehabilitation Group', 'interventionNames': ['Other: Vestibular Rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Cognitive-Motor Dual Task Activities Group', 'interventionNames': ['Other: Cognitive-Motor Dual Task Activities']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'Vestibular Rehabilitation', 'type': 'OTHER', 'description': 'Vestibular exercises will consist of static and dynamic balance exercises, VOR and eye movement training, central balance strategies and static-dynamic balance, adaptation, substitution, habituation exercises in terms of adapting to the balance system.', 'armGroupLabels': ['Vestibular Rehabilitation Group']}, {'name': 'Cognitive-Motor Dual Task Activities', 'type': 'OTHER', 'description': "In the Cognitive-Motor Dual Task Activities Group, patients will be given additional cognitive tasks (e.g. counting months, subtracting 5 from 100, etc.) in line with the physiotherapist's commands simultaneously with balance and functional activities (such as stepping forwards-sideways-backwards, sitting-standing).", 'armGroupLabels': ['Cognitive-Motor Dual Task Activities Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ezgi Eryıldız, PhD (c)', 'role': 'CONTACT', 'email': 'fzt.ezgigul@gmail.com', 'phone': '+905071180878'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Ezgi Eryıldız', 'investigatorAffiliation': 'Marmara University'}}}}