PARKINSON DISEASE (Disorder)NCT07148700
Which Tools Better Predict Fall Risk in Parkinson's Disease: A Comparative Study of Objective, Self-Reported, and Functional Balance Assessment
An observational study of PARKINSON DISEASE (Disorder) and Parkinson, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Parkinson, Parkinson s Disease
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 30 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed with PD by a neurologist and meeting the following criteria
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Parkinson's disease (PD) is a neurodegenerative disorder characterized by bradykinesia, rigidity, tremor, and postural instability, resulting from damage to dopaminergic neurons in the substantia nigra. As symptom severity increases and the disease progresses, postural control deteriorates, and falls become more frequent. PD has an incidence of 13.43 per 100,000 individuals, and the number of people affected is expected to reach nine million by 2030. It has been reported that 30% to 90% of patients with PD experience at least one fall per year, with more than half of these patients experiencing recurrent falls. The etiology of falls in PD is multifactorial: age-related factors, disease-specific mechanisms, individual characteristics, and treatment-related issues all contribute to variations in fall risk among patients.
Falls in individuals with PD are associated with severe complications, including hospitalization, fear of falling, impairments in body structure and function, activity limitations, increased dependence in activities of daily living, social restrictions, and diminished quality of life. Preventing falls in PD, a problem with significant consequences and multiple risk factors, has been shown to reduce morbidity, mortality, and healthcare costs.
The fundamental strategy for preventing falls involves accurately identifying individuals at risk and initiating appropriate interventions early. Although the etiology of falls in PD appears complex, the literature suggests that balance impairments are the primary cause and that interventions should focus on improving balance. Therefore, it is crucial to identify tools that can effectively detect balance deficits. Determining the ideal balance assessment method for clinical practice requires consideration of test sensitivity, simplicity and feasibility, minimal equipment and cost requirements, ease of patient comprehension, and time efficiency. In addition, the ability of an assessment tool to accurately predict falls is a crucial criterion when selecting the most appropriate test.
Several assessments exist to assess fall risk and balance deficits in PD, including objective measures such as the Biodex Balance System, self-reported tools like the Falls Efficacy Scale-International (FES-I) and Morse Fall Scale, and functional balance tests such as the Mini-Balance Evaluation Systems Test (Mini-BESTest), Timed Up and Go Test, and Berg Balance Scale. Each of these tools has distinct advantages and disadvantages. For example, devices like the Biodex Balance System provide objective and sensitive data, but they may not reflect balance abilities during functional positions and activities of daily living, limiting their validity. Additionally, these devices require specialized equipment and can be costly.
Self-reported scales such as the FES-I are valuable as they assess an individual's perceived balance confidence during activities of daily living, including eating, personal hygiene, dressing, and transfers. However, because these assessments rely on individuals recalling their fear of falling during specific activities, responses may be influenced by memory bias or inaccurate self-perception.
Functional tests like the Mini-BESTest have the advantage of assessing task-based performance across multiple dimensions of postural control (e.g., static/dynamic balance, sensory integration, anticipatory and reactive postural adjustments) and can guide individualized treatment strategies. Nevertheless, factors such as patient motivation during testing and misunderstanding of test instructions can influence results. Functional balance tests are also time-consuming due to their multi-step structure.
Although the validity and reliability of many of these assessment tools have been established, there is insufficient evidence to determine which method best reflects actual fall risk and frequency in daily life. Furthermore, no studies have compared the predictive ability of objective, self-reported, and functional tests for future falls in patients with PD. The aim of this study is to investigate the relationship between fall frequency and three different tools for balance assessment: the Biodex Balance System, which provides objective measurements; the FES-I, which relies on self-reported data; and the Mini-BESTest, which evaluates functional balance performance.
- 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
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease Group | Participants diagnosed with Parkinson Disease by a neurologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (immediately after informed consent)
Secondary outcomes (5)
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.
Measured: At baseline (immediately after informed consent)
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.
Measured: At baseline (immediately after informed consent)
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.
Measured: At baseline (immediately after informed consent)
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.
Measured: At baseline (immediately after informed consent)
Falls Efficacy Scale-International (FES-I)
The FES-I is used to assess participants' concerns about falling during physical and social activities. The Turkish version of the scale has been validated. It consists of 16 items, each rated on a 4-point Likert scale ("not at all concerned," "somewhat concerned," "fairly concerned," "very concerned"), with total scores ranging from 16 to 64. Higher scores reflect greater fear of falling. The FES-I is reported to demonstrate excellent reliability in individuals with PD, both in the "on" (ICC = 0.94) and "off" (ICC = 0.91) drug phases.
Measured: At baseline (immediately after informed consent)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 May 2025
- Primary completion25 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Arslantürk Yıldırım, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148700
- Sponsor's protocol ID
- E-54022451-050.04-19466
- Status last verified
- Jul 2026
- First submitted
- 21 Aug 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to Share IPD: Yes. Individual participant data (IPD) that underlie the results reported in the article (after de-identification) will be shared. This will include baseline characteristics data, and outcome measures. What data will be shared: De-identified individual participant data related to primary and secondary outcomes. When data will be available: Beginning 6 months after publication of the main results and ending 5 years after publication. How data will be shared: 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.
Publications
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.
PubMed 31571503Meekes 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.
PubMed 34588228Lopes 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.
PubMed 31377123Schlenstedt 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.
PubMed 26381806Liu 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.
PubMed 35837986Camicioli 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.
PubMed 37868930Schrag 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.
PubMed 28409181Kerr 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.
PubMed 20574039Ou 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.
PubMed 34950630Dorsey 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.
PubMed 29131880
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Tools Better Predict Fall Risk in Parkinson's Disease: A Comparative Study of Objective, Self-Reported, and Functional Balance Assessment
- ClinicalTrials.gov ID
- NCT07148700
- Acronym / sponsor ID
- E-54022451-050.04-19466
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Parkinson's disease (PD) is a neurodegenerative disorder characterized by bradykinesia, rigidity, tremor, and postural instability, resulting from damage to dopaminergic neurons in the substantia nigra. As symptom severity increases and the disease progresses, postural control deteriorates, and falls become more frequent. PD has an incidence of 13.43 per 100,000 individuals, and the number of people affected is expected to reach nine million by 2030. It has been reported that 30% to 90% of patients with PD experience at least one fall per year, with more than half of these patients experiencing recurrent falls. The etiology of falls in PD is multifactorial: age-related factors, disease-specific mechanisms, individual characteristics, and treatment-related issues all contribute to variations in fall risk among patients.
Falls in individuals with PD are associated with severe complications, including hospitalization, fear of falling, impairments in body structure and function, activity limitations, increased dependence in activities of daily living, social restrictions, and diminished quality of life. Preventing falls in PD, a problem with significant consequences and multiple risk factors, has been shown to reduce morbidity, mortality, and healthcare costs.
The fundamental strategy for preventing falls involves accurately identifying individuals at risk and initiating appropriate interventions early. Although the etiology of falls in PD appears complex, the literature suggests that balance impairments are the primary cause and that interventions should focus on improving balance. Therefore, it is crucial to identify tools that can effectively detect balance deficits. Determining the ideal balance assessment method for clinical practice requires consideration of test sensitivity, simplicity and feasibility, minimal equipment and cost requirements, ease of patient comprehension, and time efficiency. In addition, the ability of an assessment tool to accurately predict falls is a crucial criterion when selecting the most appropriate test.
Several assessments exist to assess fall risk and balance deficits in PD, including objective measures such as the Biodex Balance System, self-reported tools like the Falls Efficacy Scale-International (FES-I) and Morse Fall Scale, and functional balance tests such as the Mini-Balance Evaluation Systems Test (Mini-BESTest), Timed Up and Go Test, and Berg Balance Scale. Each of these tools has distinct advantages and disadvantages. For example, devices like the Biodex Balance System provide objective and sensitive data, but they may not reflect balance abilities during functional positions and activities of daily living, limiting their validity. Additionally, these devices require specialized equipment and can be costly.
Self-reported scales such as the FES-I are valuable as they assess an individual's perceived balance confidence during activities of daily living, including eating, personal hygiene, dressing, and transfers. However, because these assessments rely on individuals recalling their fear of falling during specific activities, responses may be influenced by memory bias or inaccurate self-perception.
Functional tests like the Mini-BESTest have the advantage of assessing task-based performance across multiple dimensions of postural control (e.g., static/dynamic balance, sensory integration, anticipatory and reactive postural adjustments) and can guide individualized treatment strategies. Nevertheless, factors such as patient motivation during testing and misunderstanding of test instructions can influence results. Functional balance tests are also time-consuming due to their multi-step structure.
Although the validity and reliability of many of these assessment tools have been established, there is insufficient evidence to determine which method best reflects actual fall risk and frequency in daily life. Furthermore, no studies have compared the predictive ability of objective, self-reported, and functional tests for future falls in patients with PD. The aim of this study is to investigate the relationship between fall frequency and three different tools for balance assessment: the Biodex Balance System, which provides objective measurements; the FES-I, which relies on self-reported data; and the Mini-BESTest, which evaluates functional balance performance.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease Group | – | –Participants diagnosed with Parkinson Disease by a neurologist |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with PD by a neurologist and meeting the following criteria
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fall Diary
Time frame: At baseline (immediately after informed consent)
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.
5 secondary outcomes
Unified Parkinson's Disease Rating Scale-III (UPDRS-III)
Time frame: At baseline (immediately after informed consent)
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time frame: At baseline (immediately after informed consent)
Biodex Balance System (BBS)-Postural Stability Test (PST)
Time frame: At baseline (immediately after informed consent)
Biodex Balance System (BBS)-Fall Risk Index (FRI) Test
Time frame: At baseline (immediately after informed consent)
Falls Efficacy Scale-International (FES-I)
Time frame: At baseline (immediately after informed consent)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Results publication: PubMed 31571503Winser 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.
- Results publication: PubMed 34588228Meekes 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.
- Results publication: PubMed 31377123Lopes 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.
- Results publication: PubMed 26381806Schlenstedt 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.
- Results publication: PubMed 35837986Liu 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.
- Results publication: PubMed 37868930Camicioli 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.
- Results publication: PubMed 28409181Schrag 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.
- Results publication: PubMed 20574039Kerr 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.
- Results publication: PubMed 34950630Ou 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.
- Results publication: PubMed 29131880Dorsey 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.
- Individual participant dataSharing planned: Yes. Plan to Share IPD: Yes. Individual participant data (IPD) that underlie the results reported in the article (after de-identification) will be shared. This will include baseline characteristics data, and outcome measures. What data will be shared: De-identified individual participant data related to primary and secondary outcomes. When data will be available: Beginning 6 months after publication of the main results and ending 5 years after publication. How data will be shared: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PARKINSON DISEASE (Disorder) and Parkinson, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall Diary (time frame: At baseline (immediately after informed consent)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07148700, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.