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Clinical Trials/NCT07058714
NCT07058714CompletedNot Applicable

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

Biruni University1 site in 1 country30 target enrollmentStarted: July 1, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Mini-Balance Evaluation Systems Test (Mini-BESTest)

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
40 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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)

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Mini-Balance Evaluation Systems Test (Mini-BESTest)

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Biruni University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Guzin Kaya Aytutuldu

Assistant Professor

Biruni University

Study Sites (1)

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