Idiopathic Parkinson's DiseaseNCT05671341
Comparison of Balance, Activity-specific Balance Confidence and Quality of Life in Parkinson's Patients
An observational study of Idiopathic Parkinson's Disease, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's disease is characterized by cardinal motor signs and motor freezing, gait, posture and balance disorder. About 80% of the causes of falls in Parkinson's patients are due to postural instability and motor freezing, and patients' quality of life is significantly affected. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- Assessment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Dec 2022to 28 Feb 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's patients who applied to Nigde Omer Halisdemir University Training and Research Hospital Neurology Clinic will be included in this study.
Who may be able to join
- Being diagnosed with idiopathic Parkinson's disease
- Healthy individuals who do not have musculoskeletal disease or any neurological disease that may affect assessments
- Older than 50 years old
- Volunteer to participate in the study
- Grade 1-3 on the Modified Hoehn-Yahr Scale
- To have a score above 24 in the Standardized Mini Mental Test
- To have a hemogram follow-up in the last 1 month before the date of participation in the study.
- Being able to walk independently on flat ground
Who cannot join
- Having an additional or psychiatric disease other than Parkinson's disease
- Lack of cooperation
- Presence of orthopedic problems (such as fractures, osteoporosis, osteomyelitis)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nigde Omer Halisdemir University Treaning and Research Hospital
Niğde, Niğde Province, 51200
About this study
Official title: Comparison of Balance, Activity-specific Balance Confidence and Quality of Life in Parkinson's Patients with Freezing and Relationship Between Neutrophil/lymphocyte Ratio
Parkinson's disease is characterized by cardinal motor signs and motor freezing, gait, posture and balance disorder. About 80% of the causes of falls in Parkinson's patients are due to postural instability and motor freezing, and patients' quality of life is significantly affected. Loss of balance and falls, which are frequently experienced in Parkinson's patients, cause individuals to feel insecure during activities. It is thought that the quality of life of PD patients whose movements are restricted due to the fear of falling may also be negatively affected. The neutrophil/lymphocyte ratio is a marker of peripheral inflammation. The relationship of peripheral inflammation to balance, activity-specific balance confidence, and quality of life in individuals is unclear. The aim of this study was to compare balance, activity-specific balance confidence, quality of life, and the relationship between neutrophil/lymphocyte ratio in Parkinson's patients with and without freezing.
Read the detailed description
Parkinson's disease is characterized by cardinal motor signs and motor freezing, gait, posture and balance disorder. About 80% of the causes of falls in Parkinson's patients are due to postural instability and motor freezing, and patients' quality of life is significantly affected. Loss of balance and falls, which are frequently experienced in Parkinson's patients, cause individuals to feel insecure during activities. It is thought that the quality of life of PD patients whose movements are restricted due to the fear of falling may also be negatively affected. The neutrophil/lymphocyte ratio is a marker of peripheral inflammation. The relationship of peripheral inflammation to balance, activity-specific balance confidence, and quality of life in individuals is unclear.
The aim of this study was to compare balance, activity-specific balance confidence, quality of life, and the relationship between neutrophil/lymphocyte ratio in Parkinson's patients with and without freezing.
A total of 20 Parkinson's Disease age of older the 50 participate in the research. Participants were divide into two groups with and without freezing.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- Assessment
- Keywords
- Parkinson's disease, Balance, Balance confidence, Quality of life, Freezing, Neutrophil/Lymphocyte ratio
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentDiagnostic test
Tandem walking test, Tandem Stance test, Activity-specific Balance Confidence Parkinson's Disease Quality of Life-8 N/L ratio Tinetti Balance Test UPDRS
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Patients with Motor Freezing | Individuals with Parkinson's Disease with motor freezing were included in this group. Receives: Diagnostic Test: Assessment | |
| Parkinson's Patients Without Motor Freezing | Individuals with Parkinson's Disease without motor freeze were included in this group. Receives: Diagnostic Test: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freezing of Gait Questionnaire
The scale is a scale that evaluates motor freezing in Parkinson's patients. It is questioned whether freezing occurs during activities such as walking and turning on the 6-item scale developed. In addition, in the presence of freezing, the severity, frequency and duration of freezing are recorded. The higher the score, the higher the freezing.
Measured: Baseline
The Tinetti Balance and Gait Test
It provides useful information on the ability of sick individuals to comfortably perform various functional tasks. For this reason, it is an easily and inexpensively applicable scale. This test consists of two parts and a total of 16 questions. These are walking in the 7-question part and balance in the 9-question part. The total score in the first 9 questions constitutes the balance score, and the total score in the next 7 questions constitutes the walking score. The total score in balance and walking constitutes the TDYT total score. TDYT score calculation is done by observation. 2 points indicate that the movement is performed correctly, 1 point indicates that there are adaptations in the movement, and 0 points indicate that the desired movement cannot be performed. A total score of 18 or less after TDYT indicates a high fall risk, a score of 19-24 indicates a moderate fall risk, and a score above 24 indicates a low risk of falling.
Measured: Baseline
Activity-Specific Balance Confidence
Individuals are asked 16 questions about daily living activities inside and outside the home. For each question, individuals are asked to rate their confidence in the activity between 0 and 100%. These values are added together and divided by 16 and the nearest decimal value is accepted as the value of the scale. The higher the score, the higher the balance confidence of individuals.
Measured: Baseline
Parkinson's Disease Quality of Life-8
One question from each of the eight domains in PHA-39, which are activities of daily living, physical discomfort, cognition, communication, emotional well-being, mobility, social support and stigma, gives the total domain score.Each question is scored between 0-4 points and points are added up. The total score is then divided by the total possible score and given as a percentage point out of 100. The lower the score, the higher the quality of life.
Measured: Baseline
Hemogramme
The neutrophil/lymphocyte ratio is a marker of peripheral inflammation.
Measured: Baseline
Secondary outcomes (3)
Unified Parkinson's Disease Rating Scale
This scale was created to evaluate the motor performance, mental and mental status, and activities of daily living of Parkinson's patients. It also evaluates motor fluctuations, dyskinesias, and autonomic dysfunction. The scale was prepared as 4 parts and 42 items. When the extremities are evaluated separately, it increases up to 55 items. Items are rated from 0 (no symptoms or signs) to 4 (most severe symptoms and signs). The first part evaluates the non-motor features of the disease, such as thoughts, behaviors, and emotions. The second part consists of activities of daily living. In the third part, motor examination, in the fourth part, the complications of the treatment are given. It is used to evaluate the symptoms of the disease and the complications that develop due to treatment. In this scale, which consists of 4 parts, the scoring of each item is between 0-4 points. The increase in the total score reflects the increase in the severity of the symptoms.
Measured: Baseline
Tandem stance test:
During the tandem stance test, which allows the evaluation of static balance, the individual will be asked to position the heel of one of his feet to the tip of the other. While the individual maintains this position without support, the time elapsed until the individual's balance is broken will be recorded with the help of a stopwatch. For individuals without balance problems, the test takes 30 seconds. It will be continued until it is full.
Measured: Baseline
Tandem walking test
The tandem walking test is a clinical assessment of dynamic balance associated with falls in many studies. It is recommended as a simple tool to identify those at risk of falling. The participant is asked to walk 10 steps in a straight line with the heel of one foot touching the toe of the other foot, with his hands folded over the chest, wearing comfortable shoes, and the time is recorded.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start8 Dec 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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-control
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asli Demirtaş, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671341
- Sponsor's protocol ID
- 2022/106
- Status last verified
- Aug 2024
- First submitted
- 1 Jan 2023
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Balance, Activity-specific Balance Confidence and Quality of Life in Parkinson's Patients with Freezing and Relationship Between Neutrophil/lymphocyte Ratio
- ClinicalTrials.gov ID
- NCT05671341
- Acronym / sponsor ID
- 2022/106
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Parkinson's disease, Balance, Balance confidence, Quality of life, Freezing, Neutrophil/Lymphocyte ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 4 Jan 2023 (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.
Parkinson's disease is characterized by cardinal motor signs and motor freezing, gait, posture and balance disorder. About 80% of the causes of falls in Parkinson's patients are due to postural instability and motor freezing, and patients' quality of life is significantly affected. Loss of balance and falls, which are frequently experienced in Parkinson's patients, cause individuals to feel insecure during activities. It is thought that the quality of life of PD patients whose movements are restricted due to the fear of falling may also be negatively affected. The neutrophil/lymphocyte ratio is a marker of peripheral inflammation. The relationship of peripheral inflammation to balance, activity-specific balance confidence, and quality of life in individuals is unclear. The aim of this study was to compare balance, activity-specific balance confidence, quality of life, and the relationship between neutrophil/lymphocyte ratio in Parkinson's patients with and without freezing.
Detailed description
Parkinson's disease is characterized by cardinal motor signs and motor freezing, gait, posture and balance disorder. About 80% of the causes of falls in Parkinson's patients are due to postural instability and motor freezing, and patients' quality of life is significantly affected. Loss of balance and falls, which are frequently experienced in Parkinson's patients, cause individuals to feel insecure during activities. It is thought that the quality of life of PD patients whose movements are restricted due to the fear of falling may also be negatively affected. The neutrophil/lymphocyte ratio is a marker of peripheral inflammation. The relationship of peripheral inflammation to balance, activity-specific balance confidence, and quality of life in individuals is unclear.
The aim of this study was to compare balance, activity-specific balance confidence, quality of life, and the relationship between neutrophil/lymphocyte ratio in Parkinson's patients with and without freezing.
A total of 20 Parkinson's Disease age of older the 50 participate in the research. Participants were divide into two groups with and without freezing.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Patients with Motor Freezing | – | Diagnostic Test: AssessmentIndividuals with Parkinson's Disease with motor freezing were included in this group. |
| Parkinson's Patients Without Motor Freezing | – | Diagnostic Test: AssessmentIndividuals with Parkinson's Disease without motor freeze were included in this group. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's patients who applied to Nigde Omer Halisdemir University Training and Research Hospital Neurology Clinic will be included in this study.
Key inclusion criteria (8 listed)
- Being diagnosed with idiopathic Parkinson's disease
- Healthy individuals who do not have musculoskeletal disease or any neurological disease that may affect assessments
- Older than 50 years old
- Volunteer to participate in the study
- Grade 1-3 on the Modified Hoehn-Yahr Scale
Key exclusion criteria (3 listed)
- Having an additional or psychiatric disease other than Parkinson's disease
- Lack of cooperation
- Presence of orthopedic problems (such as fractures, osteoporosis, osteomyelitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentTandem walking test, Tandem Stance test, Activity-specific Balance Confidence Parkinson's Disease Quality of Life-8 N/L ratio Tinetti Balance Test UPDRS | Diagnostic test | Parkinson's Patients Without Motor Freezing, Parkinson's Patients with Motor Freezing |
Primary outcome
Freezing of Gait Questionnaire
Time frame: Baseline
The scale is a scale that evaluates motor freezing in Parkinson's patients. It is questioned whether freezing occurs during activities such as walking and turning on the 6-item scale developed. In addition, in the presence of freezing, the severity, frequency and duration of freezing are recorded. The higher the score, the higher the freezing.
The Tinetti Balance and Gait Test
Time frame: Baseline
It provides useful information on the ability of sick individuals to comfortably perform various functional tasks. For this reason, it is an easily and inexpensively applicable scale. This test consists of two parts and a total of 16 questions. These are walking in the 7-question part and balance in the 9-question part. The total score in the first 9 questions constitutes the balance score, and the total score in the next 7 questions constitutes the walking score. The total score in balance and walking constitutes the TDYT total score. TDYT score calculation is done by observation. 2 points indicate that the movement is performed correctly, 1 point indicates that there are adaptations in the movement, and 0 points indicate that the desired movement cannot be performed. A total score of 18 or less after TDYT indicates a high fall risk, a score of 19-24 indicates a moderate fall risk, and a score above 24 indicates a low risk of falling.
Activity-Specific Balance Confidence
Time frame: Baseline
Individuals are asked 16 questions about daily living activities inside and outside the home. For each question, individuals are asked to rate their confidence in the activity between 0 and 100%. These values are added together and divided by 16 and the nearest decimal value is accepted as the value of the scale. The higher the score, the higher the balance confidence of individuals.
Parkinson's Disease Quality of Life-8
Time frame: Baseline
One question from each of the eight domains in PHA-39, which are activities of daily living, physical discomfort, cognition, communication, emotional well-being, mobility, social support and stigma, gives the total domain score.Each question is scored between 0-4 points and points are added up. The total score is then divided by the total possible score and given as a percentage point out of 100. The lower the score, the higher the quality of life.
Hemogramme
Time frame: Baseline
The neutrophil/lymphocyte ratio is a marker of peripheral inflammation.
3 secondary outcomes
Unified Parkinson's Disease Rating Scale
Time frame: Baseline
Tandem stance test:
Time frame: Baseline
Tandem walking test
Time frame: Baseline
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 3 Sep 2024.
- 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.
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 Idiopathic Parkinson's Disease, run by Nigde Omer Halisdemir 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 8 inclusion and 3 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 3 Sep 2024. 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?
Freezing of Gait Questionnaire (time frame: Baseline). The study lists 5 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 3 Sep 2024.