NCT05671341

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

January 1, 2023

Last Update Submit

August 29, 2024

Conditions

Idiopathic Parkinson's Disease

Keywords

Parkinson's diseaseBalanceBalance confidenceQuality of lifeFreezingNeutrophil/Lymphocyte ratio

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • Hemogramme

    The neutrophil/lymphocyte ratio is a marker of peripheral inflammation.

    Baseline

Secondary Outcomes (3)

  • Unified Parkinson's Disease Rating Scale

    Baseline

  • Tandem stance test:

    Baseline

  • Tandem walking test

    Baseline

Other Outcomes (2)

  • Standardized Mini Mental Test

    Baseline

  • Modified Hoehn and Yahr Scale

    Baseline

Study Arms (2)

Parkinson's Patients with Motor Freezing

Individuals with Parkinson's Disease with motor freezing were included in this group.

Diagnostic Test: Assessment

Parkinson's Patients Without Motor Freezing

Individuals with Parkinson's Disease without motor freeze were included in this group.

Diagnostic Test: Assessment

Interventions

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

Parkinson's Patients Without Motor FreezingParkinson's Patients with Motor Freezing

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parkinson's patients who applied to Nigde Omer Halisdemir University Training and Research Hospital Neurology Clinic will be included in this study.

You may qualify if:

  • 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

You may not qualify if:

  • Having an additional or psychiatric disease other than Parkinson's disease
  • Lack of cooperation
  • Presence of orthopedic problems (such as fractures, osteoporosis, osteomyelitis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nigde Omer Halisdemir University Treaning and Research Hospital

Niğde, Niğde Province, 51200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 4, 2023

Study Start

December 8, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

September 3, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)