NCT06283043

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

January 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

February 13, 2024

Last Update Submit

February 21, 2024

Conditions

Keywords

ParkinsonAttentionmotor functionsleep

Outcome Measures

Primary Outcomes (11)

  • TUG

    functional mobility

    second, day 1, Values over 12 seconds indicate the risk of falling

  • 10 m walking test

    walking speed

    second, day 1, lower results indicate better values, higher results indicate worse results

  • 30 sec sit-stand test

    endurance

    again,day 1, higher results indicate better values, lower results indicate worse results

  • berg balance test

    balance

    score, day 1, The score is between 0-56. A high total score indicates a good result

  • one leg stance test

    balance

    second, day 1, higher results indicate better values, lower results indicate worse results

  • functional reach test

    balance

    centimeter, day 1, higher results indicate better values, lower results indicate worse results

  • hand dinamometer

    strenght

    kilogram, day 1, higher results indicate better values, lower results indicate worse results

  • mobil application

    reaction time

    second, day 1, lower results indicate better values, higher results indicate worse results

  • Pittsburg Sleep Quality İndex

    sleep

    score, day 1, The score is between 0-21. A high total score indicates a bad result.

  • Beck Depression

    depression

    score,day 1, The total score is between 0-63. A high total score indicates that the result is bad.

  • P300

    attention

    second, day 1, lower results indicate better values, higher results indicate worse results

Study Arms (2)

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.

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parkinson Diseases and Healty Control

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Battalgazi, 44280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Movement DisordersParkinsonian DisordersConversion Disorder

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesBasal Ganglia DiseasesBrain DiseasesSomatoform DisordersMental Disorders

Study Design

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

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 28, 2024

Study Start

January 1, 2024

Primary Completion

March 1, 2024

Study Completion

March 5, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations