NCT05906693

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

1.9 years

First QC Date

June 7, 2023

Last Update Submit

June 15, 2023

Conditions

Keywords

Quality of LifeUpper Limb FunctionalityTremorElectromyographyParkinson's Disease

Outcome Measures

Primary Outcomes (6)

  • Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale

    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

    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)

    Used to assess the quality of life of Parkinson's patients

    1 year

  • Electromyography

    Used to assess the tremor amplitude of Parkinson's patients

    1 year

  • Nine-Hole Peg Test

    Used to assess the upper limb functionality of Parkinson's patients

    1 year

  • Dynamometer

    Used to assess the grip and pinch strength of Parkinson's patients

    1 year

Interventions

Parkinson's Disease Quality of Life Questionnaire (PDQ-39)

Nine-Hole Peg Test

Dynamometer

Electromyography

Hospital Anxiety and Depression Scale

The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale

Eligibility Criteria

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

Individuals with Parkinson Disease were included in the study

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, 20190, Turkey (Türkiye)

Location

Related Publications (3)

  • Kuhlman GD, Flanigan JL, Sperling SA, Barrett MJ. Predictors of health-related quality of life in Parkinson's disease. Parkinsonism Relat Disord. 2019 Aug;65:86-90. doi: 10.1016/j.parkreldis.2019.05.009. Epub 2019 May 7.

    PMID: 31118162BACKGROUND
  • Bhatia KP, Bain P, Bajaj N, Elble RJ, Hallett M, Louis ED, Raethjen J, Stamelou M, Testa CM, Deuschl G; Tremor Task Force of the International Parkinson and Movement Disorder Society. Consensus Statement on the classification of tremors. from the task force on tremor of the International Parkinson and Movement Disorder Society. Mov Disord. 2018 Jan;33(1):75-87. doi: 10.1002/mds.27121. Epub 2017 Nov 30.

    PMID: 29193359BACKGROUND
  • Louis ED, Machado DG. Tremor-related quality of life: A comparison of essential tremor vs. Parkinson's disease patients. Parkinsonism Relat Disord. 2015 Jul;21(7):729-35. doi: 10.1016/j.parkreldis.2015.04.019. Epub 2015 Apr 24.

    PMID: 25952960BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseTremor

Interventions

Quality of LifeHand StrengthPinch Strength

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthMuscle StrengthPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Buse KILINÇ, PT.MSc.

    Pamukkale University

    PRINCIPAL INVESTIGATOR
  • Nilüfer ÇETİŞLİ-KORKMAZ, PT.PhD.Prof.

    Pamukkale University

    STUDY DIRECTOR
  • Levent S. BIR, MD.PhD.Prof.

    Pamukkale University

    STUDY CHAIR
  • Ahmet D. MARANGOZ, MD.

    Klinikum Stuttgart

    STUDY CHAIR
  • Hande ŞENOL, Assist.Prof.

    Pamukkale University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT.MSc.

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 18, 2023

Study Start

January 1, 2019

Primary Completion

November 20, 2020

Study Completion

July 13, 2021

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations