Which Tools Better Predict Fall Risk in Parkinson's Disease: A Comparative Study of Objective, Self-Reported, and Functional Balance Assessment

NCT07148700 | Recruiting

• 1 other identifier: E-54022451-050.04-19466
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Falls are common in Parkinson's disease (PD), affecting 30-90% of patients annually, with more than half experiencing recurrent falls. Identifying balance assessment tools that are both practical and predictive of fall risk is therefore essential. This study aimed to investigate the relationship between fall frequency and three balance assessment tools: the Biodex Balance System (objective), the Falls Efficacy Scale-International (FES-I) (self-reported), and the Mini-Balance Evaluation Systems Test (Mini-BESTest) (functional). Methods: Patients with PD at Hoehn and Yahr stages 1-3 will be included in the study. Fall data will be collected using a fall diary, while objective balance will be assessed with the Biodex Balance System, functional performance will be evaluated with the Mini-BESTest, and self-reported balance confidence will be measured with the FES-I.

Conditions

PARKINSON DISEASE (Disorder); Parkinson; Parkinson s Disease; Parkinson Disease; Parkinson Disease (PD)

Keywords

Balance assessment; Functional test; Parkinson disease; Postural stability; Risk of falls

Outcome Measures

Primary Outcomes (1)

• Fall Diary

  A "Fall Diary" is used as a retrospective interview tool to collect information on falls that have occurred during the previous six months. Participants are asked to recall and report the number of falls within this period, along with details regarding the activity being performed at the time of the fall, the environmental context, balance strategies attempted during the fall, the method of recovery, the occurrence of any complications, and whether medical assistance or hospitalization is required. To enhance the accuracy and completeness of the retrospective fall reports, caregivers are also consulted to corroborate and supplement the participants' accounts.

  At baseline (immediately after informed consent)

Secondary Outcomes (5)

• Unified Parkinson's Disease Rating Scale-III (UPDRS-III)

  At baseline (immediately after informed consent)

• Mini-Balance Evaluation Systems Test (Mini-BESTest)

  At baseline (immediately after informed consent)

• Biodex Balance System (BBS)-Postural Stability Test (PST)

  At baseline (immediately after informed consent)

• Biodex Balance System (BBS)-Fall Risk Index (FRI) Test

  At baseline (immediately after informed consent)

• Falls Efficacy Scale-International (FES-I)

  At baseline (immediately after informed consent)

Study Arms (1)

Parkinson Disease Group

Participants diagnosed with Parkinson Disease by a neurologist

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants diagnosed with PD by a neurologist and meeting the following criteria

You may qualify if:

• Age between 40 and 80 years old
• Receiving stable dopaminergic treatment
• No other neurological disorders besides PD
• A Standardized Mini-Mental State Examination (MMSE) score \>24
• Hoehn and Yahr stage between 1-3
• Voluntarily agreed to participate in the study after receiving detailed information

You may not qualify if:

• Presence of visual, hearing impairments, cardiovascular or pulmonary diseases that could affect study outcomes
• Having mental or physical impairments severe enough to hinder communication
• Clinically unstable condition within the past month
• Participation in a rehabilitation program within the last six months

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Eyup, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• Winser SJ, Kannan P, Bello UM, Whitney SL. Measures of balance and falls risk prediction in people with Parkinson's disease: a systematic review of psychometric properties. Clin Rehabil. 2019 Dec;33(12):1949-1962. doi: 10.1177/0269215519877498. Epub 2019 Oct 1.

  PMID: 31571503 BACKGROUND

• Meekes WM, Korevaar JC, Leemrijse CJ, van de Goor IA. Practical and validated tool to assess falls risk in the primary care setting: a systematic review. BMJ Open. 2021 Sep 29;11(9):e045431. doi: 10.1136/bmjopen-2020-045431.

  PMID: 34588228 BACKGROUND

• Lopes LKR, Scianni AA, Lima LO, de Carvalho Lana R, Rodrigues-De-Paula F. The Mini-BESTest is an independent predictor of falls in Parkinson Disease. Braz J Phys Ther. 2020 Sep-Oct;24(5):433-440. doi: 10.1016/j.bjpt.2019.07.006. Epub 2019 Jul 25.

  PMID: 31377123 BACKGROUND

• Schlenstedt C, Brombacher S, Hartwigsen G, Weisser B, Moller B, Deuschl G. Comparison of the Fullerton Advanced Balance Scale, Mini-BESTest, and Berg Balance Scale to Predict Falls in Parkinson Disease. Phys Ther. 2016 Apr;96(4):494-501. doi: 10.2522/ptj.20150249. Epub 2015 Sep 17.

  PMID: 26381806 BACKGROUND

• Liu WY, Tung TH, Zhang C, Shi L. Systematic review for the prevention and management of falls and fear of falling in patients with Parkinson's disease. Brain Behav. 2022 Aug;12(8):e2690. doi: 10.1002/brb3.2690. Epub 2022 Jul 14.

  PMID: 35837986 BACKGROUND

• Camicioli R, Morris ME, Pieruccini-Faria F, Montero-Odasso M, Son S, Buzaglo D, Hausdorff JM, Nieuwboer A. Prevention of Falls in Parkinson's Disease: Guidelines and Gaps. Mov Disord Clin Pract. 2023 Sep 2;10(10):1459-1469. doi: 10.1002/mdc3.13860. eCollection 2023 Oct.

  PMID: 37868930 BACKGROUND

• Schrag A, Choudhury M, Kaski D, Gallagher DA. Why do patients with Parkinson's disease fall? A cross-sectional analysis of possible causes of falls. NPJ Parkinsons Dis. 2015 Jun 11;1:15011. doi: 10.1038/npjparkd.2015.11.

  PMID: 28409181 BACKGROUND

• Kerr GK, Worringham CJ, Cole MH, Lacherez PF, Wood JM, Silburn PA. Predictors of future falls in Parkinson disease. Neurology. 2010 Jul 13;75(2):116-24. doi: 10.1212/WNL.0b013e3181e7b688. Epub 2010 Jun 23.

  PMID: 20574039 BACKGROUND

• Ou Z, Pan J, Tang S, Duan D, Yu D, Nong H, Wang Z. Global Trends in the Incidence, Prevalence, and Years Lived With Disability of Parkinson's Disease in 204 Countries/Territories From 1990 to 2019. Front Public Health. 2021 Dec 7;9:776847. doi: 10.3389/fpubh.2021.776847. eCollection 2021.

  PMID: 34950630 BACKGROUND

• Dorsey ER, Bloem BR. The Parkinson Pandemic-A Call to Action. JAMA Neurol. 2018 Jan 1;75(1):9-10. doi: 10.1001/jamaneurol.2017.3299. No abstract available.

  PMID: 29131880 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Ayca Arslanturk-Yildirim, Msc

CONTACT

+905312891352; ayca.arslanturk@bezmialem.edu.tr

Senanur Duzenli, MSc

CONTACT

+905079296680; senanur.duzenli@bezmialem.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 29, 2025
• Study Start: May 1, 2025
• Primary Completion: August 25, 2025
• Study Completion: August 30, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 6 months after publication of the main results and ending 5 years after publication.
• Access Criteria: Data will be made available upon reasonable request to the corresponding author, after approval of a research proposal and signing of a data access agreement.

Locations

TU (1)