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临床试验/NCT07058714
NCT07058714已完成不适用

Multimodal Artificial Intelligence-Based Fall Risk Prediction in Patients With Parkinson's Disease: Single vs. Dual-Task Conditions

Biruni University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Mini-Balance Evaluation Systems Test (Mini-BESTest)

研究概览

简要总结

Parkinson's disease (PD) is characterized by motor symptoms such as bradykinesia, tremor, rigidity, and postural instability, often leading to gait disturbances and a high risk of falls. Dual-task walking assessments-requiring simultaneous motor and cognitive engagement-have gained importance in evaluating real-life mobility impairments in PD, as they more accurately reflect challenges faced during daily activities. While clinical tools such as the Timed Up and Go (TUG), Four Square Step Test (FSST), and Mini-BESTest are widely used, their in-person application may not always be feasible for individuals with mobility or access limitations. Telehealth-based assessment methods, therefore, offer practical alternatives. Recently, the integration of artificial intelligence (AI), particularly machine learning (ML), into clinical assessments has opened new possibilities for fall risk prediction by enabling the simultaneous analysis of motor, cognitive, and balance-related parameters. This study aims to predict fall risk in individuals with PD using AI-based models that incorporate multiple data sources. Furthermore, it compares the predictive accuracy of models derived from single-task and dual-task conditions, with the goal of developing a more precise and clinically useful decision-support tool for early intervention.

详细描述

Parkinson's disease (PD) is a progressive neurodegenerative disorder that primarily affects the basal ganglia, particularly the substantia nigra, leading to hallmark motor symptoms such as bradykinesia, resting tremor, muscular rigidity, and impaired postural reflexes. These motor impairments often result in gait disturbances, postural instability, and ultimately, a significantly increased risk of falls. Fall-related injuries are a major source of morbidity, reduced mobility, and increased healthcare burden in individuals with PD, making early identification of fall risk a clinical priority.

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinical diagnosis of idiopathic Parkinson's disease
  • •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)

排除标准

  • •Severe hearing or visual impairments
  • •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

结局指标

主要结局

Mini-Balance Evaluation Systems Test (Mini-BESTest)

时间窗: Mini-BESTest will be administered once during a single assessment session, which is expected to last approximately 10-15 minutes.

The Mini-BESTest is a 14-item balance assessment tool designed to evaluate dynamic balance, including postural responses, sensory orientation, and dynamic gait. The final section allows for assessment of dual-task performance within the context of a mobility test involving cognitive load. Each item is scored on a scale from 0 to 2, where 0 indicates inability to complete the task and 2 indicates normal performance. The maximum total score is 28. It is a unidimensional measure that takes approximately 15 minutes to complete and is considered valid and reliable for use in individuals with Parkinson's disease.

Four Square Step Test (FSST)

时间窗: will be administered once during a single assessment session, which is expected to last approximately 10 minutes.

This test evaluates the ability to step over obstacles in multiple directions. At the start, the participant stands in the top left square (Square 1) and faces Square 2. The stepping sequence begins clockwise through Squares 2, 4, and 3, and then continues counterclockwise through Squares 3, 4, 2, and back to 1. The clinician demonstrates the sequence, and the participant is allowed to practice. If the participant fails to complete the sequence correctly, loses balance, or touches the aid, the test is repeated. Two trials are performed, and the best time is recorded. Timing begins when the leading foot contacts Square 2 and ends when the trailing foot returns to Square 1. During this test, participants' stepping and changing direction movements will be recorded on video.

次要结局

  • Timed Up and Go Test (TUG)(The TUG test will be conducted under both single- and dual-task conditions in a single session. The total testing time, including all conditions, is estimated at approximately 7-10 minutes.)
  • Digit Span Test(The Digit Span Test will be administered once during a single session and is expected to take approximately 5 minutes to complete.)
  • Verbal fluency task(The phonemic verbal fluency task will be administered once during a single session and is expected to take approximately 3 minutes (1 minute per letter).)
  • Dual-Task Questionnaire(The dual-task questionnaire will be completed once during the assessment session and will require approximately 3-5 minutes to complete.)
  • Mental Flexibility Task(The mental flexibility task will be performed once in a single session, taking approximately 2-3 minutes depending on the participant's cognitive status)
  • Gait parameters(Video-based gait assessment will be conducted once per participant during a single session. The walking task and data recording are expected to take approximately 5-7 minutes, including marker placement and calibration.)

研究者

发起方
Biruni University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guzin Kaya Aytutuldu

Assistant Professor

Biruni University

研究点 (1)

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