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 volunteersQualifiers
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
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
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