Parkinson's DiseaseNCT03845725
Falls and Balance of Patients With Parkinson's Disease With Urinary Disturbance
An observational study of Parkinson's Disease and Falls, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the fall and balance conditions of Parkinson's patients according to their urinary complaints. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease, Falls, Balance
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 30 Jun 2019
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: A total of 80 patients who attended the Movement Disorders Outpatient Clinic of Ordu a University Educational Research Hospital in December 2019 and February 2020 will be evaluated.
Who may be able to join
- Parkinson's disease according to the United Kingdom Brain Bank diagnostic criteria
- Good cognitive functions (>24 on Standardized Mini Mental Test)
- volunteers who accept to participate in the study.
Who cannot join
- Orthopedic and / or neurological problem affecting walking or balance skills
- Not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Movement Disorders Outpatient Clinic of Ordu a University Educational Research Hospital
Ordu, Altınordu, 52200
About this study
Official title: Investigation of Falls and Balance of Patients With Parkinson's Disease With Urinary Disturbance
The aim of this study is to determine the fall and balance conditions of Parkinson's patients according to their urinary complaints.
Read the detailed description
Parkinson's disease (PD) is a slowly progressive and common neurodegenerative disease.Frequently encountered problems in lower urinary tract complaints; Bladder dysfunction, such as urinary entrapment and frequent urination.Urinary incontinence in individuals with Parkinson's disease increases the risk of falling.
The investigators will evaluate 80 patients who attended the Movement Disorders Outpatient Clinic of Ordu a University Educational Research Hospital in December 2018 and February 2019, and were diagnosed as having Parkinson's disease. Other eligibility criteria for participants were having good cognitive functions (>24 on Standardized Mini Mental Test) and were volunteers who accept to participate in the study. The investigators excluded patients that having orthopedic and / or neurological problem affecting walking and balance skills. The investigators used Unified Parkinson's Disease Rating Scale (UPDRS), modified Hoehn and Yahr Stage (H/Y), Berg Balance Scale (BBS), Falls-Efficacy Scale (FES), Timed Up and Go (TUG), and Five Times Sit to Stand Test (FTSTS), ICIQ-SF and Overactive Bladder Version-8.
- Conditions
- Parkinson's Disease, Falls, Balance, Urinary Bladder Diseases
- Medical subject headings
- Parkinson Disease, Urinary Bladder Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale
The UPDRS is used as a gold standard reference scale. Each item is scored using a 5-point scale, where 0 means an absence of symptoms and 4 represents the worst stage
Measured: Baseline
Modified Hoehn and Yahr Stage
The severity of PD was determined using the Modified Hoehn and Yahr Stage, which contains five stages.
Stage 0: No signs of disease. Stage 1: Unilateral symptoms only. Stage 2: Bilateral symptoms. No impairment of balance. Stage 3: Balance impairment. Mild to moderate disease. Physically independent. Stage 4: Severe disability, but still able to walk or stand unassisted. Stage 5: Needing a wheelchair or bedridden unless assisted.
Measured: Baseline
Berg Balance Scale
The BBS consists of 14 items and scores range from 0 (inability to perform the task) to 4 points.
Measured: Baseline
Falls-Efficacy Scale
This scale is used to measure the perceived fear of falling. It comprises 10 questions. The score of the scale change 0-100 and the score above 70 indicates the fear of falling.
Measured: Baseline
Timed Up and Go (TUG)
The TUG is a reliable and valid measurement tool to assess functional mobility in patients with PD
Measured: Baseline
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
ICIQ-SF is a short, easy-to-understand and feasible questionnaire form, which demonstrates the reliability and validity of urinary incontinence and its impact on quality of life. In ICIQ-SF questionnaire, the frequency, amount, type and effects of urinary incontinence on the daily life are questioned and scoring is performed between 0-21 values.
Measured: Baseline
Overactive Bladder Version-8
It is used for screening and diagnosis of overactive bladder. The BBS consists of 8 items. A total score of ≥8 indicates that the respondent may have an overactive bladder. The total score ranges from 0 to 40.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start1 Feb 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslıhan ÇATIKER, Ordu University
- Investigators
- Aslıhan Çatıker, Phd, Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845725
- Sponsor's protocol ID
- 2018-09
- Status last verified
- Mar 2020
- First submitted
- 16 Feb 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Falls and Balance of Patients With Parkinson's Disease With Urinary Disturbance
- ClinicalTrials.gov ID
- NCT03845725
- Acronym / sponsor ID
- 2018-09
- Conditions
- Parkinson's Disease, Falls, Balance, Urinary Bladder Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 19 Feb 2019 (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.
The aim of this study is to determine the fall and balance conditions of Parkinson's patients according to their urinary complaints.
Detailed description
Parkinson's disease (PD) is a slowly progressive and common neurodegenerative disease.Frequently encountered problems in lower urinary tract complaints; Bladder dysfunction, such as urinary entrapment and frequent urination.Urinary incontinence in individuals with Parkinson's disease increases the risk of falling.
The investigators will evaluate 80 patients who attended the Movement Disorders Outpatient Clinic of Ordu a University Educational Research Hospital in December 2018 and February 2019, and were diagnosed as having Parkinson's disease. Other eligibility criteria for participants were having good cognitive functions (>24 on Standardized Mini Mental Test) and were volunteers who accept to participate in the study. The investigators excluded patients that having orthopedic and / or neurological problem affecting walking and balance skills. The investigators used Unified Parkinson's Disease Rating Scale (UPDRS), modified Hoehn and Yahr Stage (H/Y), Berg Balance Scale (BBS), Falls-Efficacy Scale (FES), Timed Up and Go (TUG), and Five Times Sit to Stand Test (FTSTS), ICIQ-SF and Overactive Bladder Version-8.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 80 patients who attended the Movement Disorders Outpatient Clinic of Ordu a University Educational Research Hospital in December 2019 and February 2020 will be evaluated.
Key inclusion criteria (3 listed)
- Parkinson's disease according to the United Kingdom Brain Bank diagnostic criteria
- Good cognitive functions (>24 on Standardized Mini Mental Test)
- volunteers who accept to participate in the study.
Key exclusion criteria (2 listed)
- Orthopedic and / or neurological problem affecting walking or balance skills
- Not willing to participate in the study
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
Unified Parkinson's Disease Rating Scale
Time frame: Baseline
The UPDRS is used as a gold standard reference scale. Each item is scored using a 5-point scale, where 0 means an absence of symptoms and 4 represents the worst stage
Modified Hoehn and Yahr Stage
Time frame: Baseline
The severity of PD was determined using the Modified Hoehn and Yahr Stage, which contains five stages. Stage 0: No signs of disease. Stage 1: Unilateral symptoms only. Stage 2: Bilateral symptoms. No impairment of balance. Stage 3: Balance impairment. Mild to moderate disease. Physically independent. Stage 4: Severe disability, but still able to walk or stand unassisted. Stage 5: Needing a wheelchair or bedridden unless assisted.
Berg Balance Scale
Time frame: Baseline
The BBS consists of 14 items and scores range from 0 (inability to perform the task) to 4 points.
Falls-Efficacy Scale
Time frame: Baseline
This scale is used to measure the perceived fear of falling. It comprises 10 questions. The score of the scale change 0-100 and the score above 70 indicates the fear of falling.
Timed Up and Go (TUG)
Time frame: Baseline
The TUG is a reliable and valid measurement tool to assess functional mobility in patients with PD
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time frame: Baseline
ICIQ-SF is a short, easy-to-understand and feasible questionnaire form, which demonstrates the reliability and validity of urinary incontinence and its impact on quality of life. In ICIQ-SF questionnaire, the frequency, amount, type and effects of urinary incontinence on the daily life are questioned and scoring is performed between 0-21 values.
Overactive Bladder Version-8
Time frame: Baseline
It is used for screening and diagnosis of overactive bladder. The BBS consists of 8 items. A total score of ≥8 indicates that the respondent may have an overactive bladder. The total score ranges from 0 to 40.
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 10 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Aslıhan Çatıker, Phd principal investigator
Ordu University
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's Disease and Falls, run by Ordu 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 3 inclusion and 2 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 10 Mar 2020. 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?
Unified Parkinson's Disease Rating Scale (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2020.