Comparison of Balance, Activity-specific Balance Confidence and Quality of Life in Parkinson's Patients

Idiopathic Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05671341
• Other study ID #: 2022/106
• Status: Completed
• Start date: December 8, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: Nigde Omer Halisdemir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Having an additional or psychiatric disease other than Parkinson's disease

• Lack of cooperation

• Presence of orthopedic problems (such as fractures, osteoporosis, osteomyelitis)

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Diagnostic Test:
• Assessment
Tandem walking test, Tandem Stance test, Activity-specific Balance Confidence Parkinson's Disease Quality of Life-8 N/L ratio Tinetti Balance Test UPDRS

Locations

Country	Name	City	State
Turkey	Nigde Omer Halisdemir University Treaning and Research Hospital	Nigde

Sponsors (1)

Lead Sponsor	Collaborator
Nigde Omer Halisdemir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Standardized Mini Mental Test	There are 19 items in this test, which consists of 5 main parts: orientation, recording memory, attention and calculation, recall and language. The total score of the test is evaluated out of 30 and 24 points are accepted as the threshold value for the diagnosis of mild dementia. The higher the score, the higher the cognition of individuals.	Baseline
Other	Modified Hoehn and Yahr Scale	This staging scale was developed by Margaret Hoehn and Melvin Yahr (1967) for use in describing the stage of Parkinson's disease. According to the staging scale, the disease is handled in 8 stages. The lower the stage, the better of the stage Parkinson's disease.; Stage 0: No signs of disease Stage 1: Unilateral disease Stage 1.5: Unilateral plus axial involvement. Stage 2: Bilateral disease, no balance disorder. Stage 2.5: Mild bilateral disease recovering on pull test. Stage 3: Mild to moderate bilateral disease and some postural instability, physically independent.; Stage 4: Severe disability, able to stand and walk unaided. Stage 5: Unassisted wheelchair or bed dependent.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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.	Baseline
Primary	Hemogramme	The neutrophil/lymphocyte ratio is a marker of peripheral inflammation.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline