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

Parkinsonian Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06283043
• Other study ID #: 2022/3749
• Status: Enrolling by invitation
• Start date: January 1, 2024
• Est. completion date: March 5, 2024

Study information

• Verified date: February 2024
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Our study was planned to analyze motor function, endurance and sleep attention information in Parkinson's patients with detailed and objective measurements.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 54
• Est. completion date: March 5, 2024
• Est. primary completion date: March 1, 2024
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Impaired
• Conversion Disorder
• Movement Disorders
• Movement Disorders (Incl Parkinsonism)
• Parkinson Disease
• Parkinsonian Disorders

Locations

Country	Name	City	State
Turkey	Inonu University	Malatya	Battalgazi

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

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