The Quality of Life in Individuals With Parkinson's Disease

June 15, 2023 updated by: Buse KILINÇ, Pamukkale University

A Cross-sectional Study - The Quality of Life in Individuals With Parkinson's Disease: Is it Related to Functionality and Tremor Severity?

This study aimed to examine the relationship of quality of life with tremor severity and upper limb functionality in individuals with Parkinson's Disease. The differences between Parkinson's Disease Quality of Life Questionnaire, Nine-Hole Peg Test, grip and pinch strength values in the individuals with and without tremor in the study were investigated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Evaluating the relationship between Quality of Life and tremor is needed to determine the best physiotherapy and rehabilitation approaches for individuals with Parkinson's Disease. This study aimed to examine the relationship of quality of life with tremor severity and upper limb functionality in individuals with Parkinson's Disease. Fifty-two individuals with Parkinson's Disease participated in the study. Quality of Life, tremor amplitude, upper limb functionality, grip and pinch strength were evaluated. The relationship of quality of life with tremor severity and upper limb functionality was examined in individuals with Parkinson's Disease. The results of individuals with and without tremor were compared.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Pamukkale
      • Denizli, Pamukkale, Turkey, 20190
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals with Parkinson Disease were included in the study

Description

Inclusion Criteria:

  • Definite diagnosis of idiopathic Parkinson Disease
  • Age between 40 and 80 years
  • Being literate
  • Having a grade between 1-4 from the Modified Hoehn and Yahr Scale
  • Having a score lower than 11 in Hospital Anxiety and Depression Scale

Exclusion Criteria:

  • Who were with any other neurologic or orthopedic or rheumatologic disease affecting the upper extremity
  • Using antidepressants
  • Having vision loss
  • Deep brain stimulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale
Time Frame: 1 year
The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale. Used for the evaluation of clinical manifestations of Parkinson's disease. The scale consists of 4 subscales: the first part is Non-Motor Aspects of Experiences of Daily Living (13), the second part is Motor Aspects of Experiences of Daily Living (13), the third part is Motor Examination (33), and the fourth part is Motor Complications (6). The total number of items in the scale is 65. The minimum score is 0. The maximum MDS-UPDRS score is higher, given the additional items and scores for each body area, with a maximum score of 272. Higher scores indicate greater impact of Parkinson Disease symptoms.
1 year
Hospital Anxiety and Depression Scale
Time Frame: 1 year
The Hospital Anxiety and Depression Scale aims to measure symptoms of anxiety and depression and consists of 14 items, seven items for the anxiety subscale (Hospital Anxiety and Depression Scale Anxiety) and seven for the depression subscale (Hospital Anxiety and Depression Scale Depression). Each item is scored on a response-scale with four alternatives ranging between 0 and 3. After adjusting for six items that are reversed scored, all responses are summed to obtain the two subscales. Both depression and anxiety subheadings are scored between 0 and 21. Higher scores indicate greater levels of anxiety or depression. Cut-off scores are 8-10 for doubtful cases and ≥11 for definite cases.
1 year
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Time Frame: 1 year
Used to assess the quality of life of Parkinson's patients
1 year
Electromyography
Time Frame: 1 year
Used to assess the tremor amplitude of Parkinson's patients
1 year
Nine-Hole Peg Test
Time Frame: 1 year
Used to assess the upper limb functionality of Parkinson's patients
1 year
Dynamometer
Time Frame: 1 year
Used to assess the grip and pinch strength of Parkinson's patients
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamukkale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Buse KILINÇ, PT.MSc., Pamukkale University
  • Study Director: Nilüfer ÇETİŞLİ-KORKMAZ, PT.PhD.Prof., Pamukkale University
  • Study Chair: Levent S. BIR, MD.PhD.Prof., Pamukkale University
  • Study Chair: Ahmet D. MARANGOZ, MD., Klinikum Stuttgart
  • Study Chair: Hande ŞENOL, Assist.Prof., Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 60116787-020/45991
  • 2019SABE021 (Other Grant/Funding Number: PAU Scientific Research Projects Coordination)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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