- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05906693
The Quality of Life in Individuals With Parkinson's Disease
June 15, 2023 updated by: Buse KILINÇ, Pamukkale University
A Cross-sectional Study - The Quality of Life in Individuals With Parkinson's Disease: Is it Related to Functionality and Tremor Severity?
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Evaluating the relationship between Quality of Life and tremor is needed to determine the best physiotherapy and rehabilitation approaches for individuals with Parkinson's Disease.
This study aimed to examine the relationship of quality of life with tremor severity and upper limb functionality in individuals with Parkinson's Disease.
Fifty-two individuals with Parkinson's Disease participated in the study.
Quality of Life, tremor amplitude, upper limb functionality, grip and pinch strength were evaluated.
The relationship of quality of life with tremor severity and upper limb functionality was examined in individuals with Parkinson's Disease.
The results of individuals with and without tremor were compared.
Study Type
Observational
Enrollment (Actual)
52
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
-
-
Pamukkale
-
Denizli, Pamukkale, Turkey, 20190
- Pamukkale 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
No
Sampling Method
Non-Probability Sample
Study Population
Individuals with Parkinson Disease were included in the study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Who were with any other neurologic or orthopedic or rheumatologic disease affecting the upper extremity
- Using antidepressants
- Having vision loss
- Deep brain stimulation
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale
Time Frame: 1 year
|
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
Time Frame: 1 year
|
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)
Time Frame: 1 year
|
Used to assess the quality of life of Parkinson's patients
|
1 year
|
Electromyography
Time Frame: 1 year
|
Used to assess the tremor amplitude of Parkinson's patients
|
1 year
|
Nine-Hole Peg Test
Time Frame: 1 year
|
Used to assess the upper limb functionality of Parkinson's patients
|
1 year
|
Dynamometer
Time Frame: 1 year
|
Used to assess the grip and pinch strength of Parkinson's patients
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Buse KILINÇ, PT.MSc., Pamukkale University
- Study Director: Nilüfer ÇETİŞLİ-KORKMAZ, PT.PhD.Prof., Pamukkale University
- Study Chair: Levent S. BIR, MD.PhD.Prof., Pamukkale University
- Study Chair: Ahmet D. MARANGOZ, MD., Klinikum Stuttgart
- Study Chair: Hande ŞENOL, Assist.Prof., Pamukkale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
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, 2019
Primary Completion (Actual)
November 20, 2020
Study Completion (Actual)
July 13, 2021
Study Registration Dates
First Submitted
June 7, 2023
First Submitted That Met QC Criteria
June 7, 2023
First Posted (Estimated)
June 16, 2023
Study Record Updates
Last Update Posted (Estimated)
June 19, 2023
Last Update Submitted That Met QC Criteria
June 15, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60116787-020/45991
- 2019SABE021 (Other Grant/Funding Number: PAU Scientific Research Projects Coordination)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on Quality of life
-
Roswell Park Cancer InstituteTerminatedQuality of LifeUnited States
-
Tumor Center RegensburgGerman Cancer AidCompletedQuality of Life | Breast Cancer | Breast NeoplasmsGermany
-
Sidney Kimmel Cancer Center at Thomas Jefferson...RecruitingGlioblastoma | WHO Grade III Glioma | WHO Grade II GliomaUnited States
-
Instituto do Cancer do Estado de São PauloCompleted
-
University Hospital, MontpellierPediatric and Congenital Cardiology Department of Necker-enfant malades University...CompletedQuality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years (QoL-CHD-5-7)Congenital Heart DiseaseFrance
-
Wake Forest University Health SciencesWithdrawnLung Metastases | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Recurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma
-
City of Hope Medical CenterNational Cancer Institute (NCI)Recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Neuropathy | COVID-19 InfectionUnited States