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

Enrolling by invitation

Conditions

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

Observational

Enrollment (Estimated)

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
        • Inonu 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

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
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

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

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)

January 1, 2024

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 5, 2024

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Estimated)

February 28, 2024

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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