Multimodal Artificial Intelligence Based Fall Risk Prediction in Parkinson's Disease
NCT ID: NCT07058714
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2025-07-01
2025-09-15
Brief Summary
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Detailed Description
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Traditional balance and gait assessments, such as the Timed Up and Go (TUG) test, the Four Square Step Test (FSST), and the Mini-Balance Evaluation Systems Test (Mini-BESTest), have been widely employed to evaluate static and dynamic balance components in clinical settings. However, these assessments are often conducted under single-task conditions, which may not fully capture the complex, real-life demands placed on individuals with PD. In contrast, dual-task paradigms-where individuals perform a cognitive or motor secondary task while walking-have demonstrated greater sensitivity in detecting subtle deficits in postural control, as they mimic everyday situations more closely.
Nevertheless, the practical implementation of such assessments is often hindered by logistical constraints, particularly among individuals with limited mobility or geographic access to healthcare facilities. In this context, telehealth-based assessment strategies are gaining momentum due to their ability to facilitate remote monitoring and evaluation with minimal equipment and reduced resource requirements.
Recent advancements in artificial intelligence (AI), especially machine learning (ML) techniques, offer promising solutions for enhancing the predictive power of clinical assessments. ML algorithms can integrate and analyze complex datasets encompassing motor, cognitive, and balance-related parameters without relying on predefined statistical assumptions. These models are capable of identifying nonlinear relationships and subtle patterns within the data, thereby enabling more individualized and accurate fall risk predictions.
The primary objective of this study is to develop and validate AI-based predictive models for fall risk estimation in individuals with Parkinson's disease by incorporating multimodal data obtained from both single-task and dual-task walking assessments. Additionally, the study aims to compare the predictive performance of models derived under these two conditions to determine whether dual-task data enhance the sensitivity and specificity of fall risk classification. Through this approach, the research seeks to establish a clinically relevant, remote-friendly, and data-driven decision-support tool to inform timely interventions and personalized rehabilitation strategies.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Hoehn and Yahr stage between 1 and 3
A score of at least 21 on the Montreal Cognitive Assessment (MoCA)
Stable medication regimen during the past month
Assessment conducted during the patient's "on" period
Ability to walk independently on a flat surface (Functional Ambulation Classification ≥ 3)
Exclusion Criteria
Presence of other neurological, cardiovascular, or orthopedic conditions affecting gait
Diagnosis of any other neurological disorder (e.g., dementia, cerebrovascular disease)
Less than 5 years of formal education
Presence of vascular pathology in the lower extremities
40 Years
75 Years
ALL
No
Sponsors
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Biruni University
OTHER
Responsible Party
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Guzin Kaya Aytutuldu
Assistant Professor
Principal Investigators
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Guzin Kaya Aytutuldu
Role: PRINCIPAL_INVESTIGATOR
Biruni University
Locations
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Biruni University
Istanbul, Zeytinburnu, Turkey (Türkiye)
Countries
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References
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Boddy A, Mitchell K, Ellison J, Brewer W, Perry LA. Reliability and validity of modified Four Square Step Test (mFSST) performance in individuals with Parkinson's disease. Physiother Theory Pract. 2023 May;39(5):1038-1043. doi: 10.1080/09593985.2022.2031360. Epub 2022 Jan 29.
Caronni A, Amadei M, Diana L, Sangalli G, Scarano S, Perucca L, Rota V, Bolognini N. In Parkinson's disease, dual-tasking reduces gait smoothness during the straight-walking and turning-while-walking phases of the Timed Up and Go test. BMC Sports Sci Med Rehabil. 2025 Mar 7;17(1):42. doi: 10.1186/s13102-025-01068-8.
Chen IC, Chuang IC, Chang KC, Chang CH, Wu CY. Dual task measures in older adults with and without cognitive impairment: response to simultaneous cognitive-exercise training and minimal clinically important difference estimates. BMC Geriatr. 2023 Oct 16;23(1):663. doi: 10.1186/s12877-023-04390-3.
Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002 Nov;83(11):1566-71. doi: 10.1053/apmr.2002.35469.
Dou J, Wang J, Gao X, Wang G, Bai Y, Liang Y, Yang K, Yang Y, Zhang L. Effectiveness of Telemedicine Interventions on Motor and Nonmotor Outcomes in Parkinson Disease: Systematic Review and Network Meta-Analysis. J Med Internet Res. 2025 Jun 3;27:e71169. doi: 10.2196/71169.
Silva-Batista C, de Almeida FO, Wilhelm JL, Horak FB, Mancini M, King LA. Telerehabilitation by Videoconferencing for Balance and Gait in People with Parkinson's Disease: A Scoping Review. Geriatrics (Basel). 2024 May 23;9(3):66. doi: 10.3390/geriatrics9030066.
Other Identifiers
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BiruniUniverc
Identifier Type: -
Identifier Source: org_study_id
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