Effect of Motor Function, Depression and Sleep Quality on Attention in Parkinson's Disease

February 21, 2024 updated by: Burcu Talu, Inonu University
Our study was planned to analyze motor function, endurance and sleep attention information in Parkinson's patients with detailed and objective measurements.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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.

Detailed Description

Parkinson's Disease (PD) is a neurodegenerative disease that occurs with the loss of dopaminergic neurons in the basal ganglia (BG) and subsequently affects multiple brain regions. There are studies that evaluate executive functions rather than cognitive functions in Parkinson's patients. However, objective evaluations of the attention parameter are quite rare. Accordingly, our study was planned to examine the effects of motor function, depression and sleep on attention in Parkinson's patients with detailed and objective measurements. Parkinson's patients (n=27) and healthy controls (n=27) aged between 40-85 will be included in the study. Balance evaluation of the individuals participating in the study was carried out by functional reaching test, one-leg standing test and Berg balance scale; Endurance with a 30-second sit-and-stand test; reaction time; with mobile application; muscle strength by hand dynamometer; functional mobility with time up and go test; walking speed, with 10 m walk test; attention with the P300 device; depression, with the Beck depression scale; Sleep quality will be assessed with the Pittsburg sleep questionnaire. At the end of the study, the effects of motor functions, sleep and depression on attention will be examined and compared with healthy controls.

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 (Estimated)

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.
54

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
    • Battalgazi
      • Malatya, Battalgazi, Turkey, 44280
        • Inonü 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

N/A

Sampling Method

Non-Probability Sample

Study Population

Parkinson Diseases and Healty Control

Description

Inclusion Criteria:

  • Being 1,2 or 3 according to the Hoehn and yahr scale
  • Being between the ages of 40-85
  • Being diagnosed with Parkinson's according to UPDS
  • Being able to read and write
  • Being able to walk independently
  • Agreeing to participate in the study after providing detailed information about the research.
  • Mini mental test>24

Exclusion Criteria:

  • Having severe hearing/visual impairment-loss
  • Having an orthopedic, neurological or metabolic disease that may interfere with working
  • Having deep brain stimulation applied
  • Those with advanced cognitive impairment
  • Individuals with dementia
  • Patients taking anticholinergic, antidepressive or anxiolytic medications that may affect cognition, and those with other medical or neurological causes that may cause cognitive effects.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
experimental group
Parkinson's patients will be included and the evaluations specified in the method section will be applied.
control group
The healthy group will be included and the evaluations specified in the method section will be applied.

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
TUG
Time Frame: second, day 1, Values over 12 seconds indicate the risk of falling
functional mobility
second, day 1, Values over 12 seconds indicate the risk of falling
10 m walking test
Time Frame: second, day 1, lower results indicate better values, higher results indicate worse results
walking speed
second, day 1, lower results indicate better values, higher results indicate worse results
30 sec sit-stand test
Time Frame: again,day 1, higher results indicate better values, lower results indicate worse results
endurance
again,day 1, higher results indicate better values, lower results indicate worse results
berg balance test
Time Frame: score, day 1, The score is between 0-56. A high total score indicates a good result
balance
score, day 1, The score is between 0-56. A high total score indicates a good result
one leg stance test
Time Frame: second, day 1, higher results indicate better values, lower results indicate worse results
balance
second, day 1, higher results indicate better values, lower results indicate worse results
functional reach test
Time Frame: centimeter, day 1, higher results indicate better values, lower results indicate worse results
balance
centimeter, day 1, higher results indicate better values, lower results indicate worse results
hand dinamometer
Time Frame: kilogram, day 1, higher results indicate better values, lower results indicate worse results
strenght
kilogram, day 1, higher results indicate better values, lower results indicate worse results
mobil application
Time Frame: second, day 1, lower results indicate better values, higher results indicate worse results
reaction time
second, day 1, lower results indicate better values, higher results indicate worse results
Pittsburg Sleep Quality İndex
Time Frame: score, day 1, The score is between 0-21. A high total score indicates a bad result.
sleep
score, day 1, The score is between 0-21. A high total score indicates a bad result.
Beck Depression
Time Frame: score,day 1, The total score is between 0-63. A high total score indicates that the result is bad.
depression
score,day 1, The total score is between 0-63. A high total score indicates that the result is bad.
P300
Time Frame: second, day 1, lower results indicate better values, higher results indicate worse results
attention
second, day 1, lower results indicate better values, higher results indicate worse results

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.
Inonu University

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, 2024

Primary Completion (Estimated)

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.
March 1, 2024

Study Completion (Estimated)

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.
March 5, 2024

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).
February 13, 2024

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.
February 21, 2024

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.
February 28, 2024

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.
February 28, 2024

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.
February 21, 2024

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.
February 1, 2024

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.
  • 2022/3749

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings