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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-80
SponsorBezmialem Vakif University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 1 trial group
Group A: Parkinson Disease Group

Trial outcomes

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.

Time frame
At baseline (immediately after informed consent)

Secondary outcomes

1

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

The UPDRS, developed by the Movement Disorder Society, is used as a comprehensive and widely accepted clinical tool for evaluating PD. The third part of the scale, the Motor Examination section, is utilized in this study. This section evaluates motor symptoms including speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination, toe tapping, leg agility, rising from a chair, gait, freezing of gait, postural stability, posture, trunk bradykinesia, postural tremor, kinetic tremor, resting tremor amplitude, tremor constancy, and impact of dyskinesia. It consists of 18 items scored between 0 and 4, with higher scores indicating greater symptom severity. The validity and reliability of the Turkish version have previously been established.

Time frame
At baseline (immediately after informed consent)
2

Mini-Balance Evaluation Systems Test (Mini-BESTest)

The Mini-BESTest is used as a valid and reliable clinical tool for functionally evaluating balance in individuals with PD. The test consists of 14 items across four subdomains: anticipatory postural adjustments (APA), reactive postural control (RPC), sensory orientation (SO), and dynamic gait (DG). It is scored out of 28 points and takes approximately 10-15 minutes to complete. Higher scores indicate better balance performance. Strong inter-rater and test-retest reliability as well as high concurrent validity compared with the original BESTest are being demonstrated in previous studies.

Time frame
At baseline (immediately after informed consent)
3

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

This test is used to assess participants' ability to maintain their center of balance on a static platform by measuring their deviations from the center. The overall stability index (OSI) reflects total variability, the anterior-posterior index (APSI) represents sagittal plane variability, and the medial-lateral index (MLSI) indicates frontal plane deviations. Higher scores indicate greater impairment in postural stability. The test is conducted over three trials, each lasting 30 seconds, with a 15-second rest between trials.

Time frame
At baseline (immediately after informed consent)
4

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

The FRI test involves a progressive protocol transitioning from a stable to an unstable surface and measures deviations from the center to calculate a fall risk index. In this study, the platform setting is fixed at level 12-1 for all participants.

Time frame
At baseline (immediately after informed consent)

Other outcomes

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