Parkinson DiseaseNCT05906693
The Quality of Life in Individuals With Parkinson's Disease
An observational study of Parkinson Disease and Tremor, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease, Tremor, Functionality
- What is being tested?
- Quality of life, Upper limb functionality and Grip and pinch strength
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 13 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with Parkinson Disease were included in the study
Who may be able to join
- 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
Who cannot join
- Who were with any other neurologic or orthopedic or rheumatologic disease affecting the upper extremity
- Using antidepressants
- Having vision loss
- Deep brain stimulation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Pamukkale, 20190
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease, Tremor, Functionality
- Being tested
- Quality of life, Upper limb functionality, Grip and pinch strength, Tremor amplitude, Depression and anxiety levels
- Keywords
- Quality of Life, Upper Limb Functionality, Tremor, Electromyography, Parkinson's Disease
- Medical subject headings
- Parkinson Disease, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of lifeOther
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Upper limb functionalityOther
Nine-Hole Peg Test
Grip and pinch strengthOther
Dynamometer
Tremor amplitudeOther
Electromyography
Depression and anxiety levelsOther
Hospital Anxiety and Depression Scale
Clinical manifestationsOther
The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Used to assess the quality of life of Parkinson's patients
Measured: 1 year
Electromyography
Used to assess the tremor amplitude of Parkinson's patients
Measured: 1 year
Nine-Hole Peg Test
Used to assess the upper limb functionality of Parkinson's patients
Measured: 1 year
Dynamometer
Used to assess the grip and pinch strength of Parkinson's patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jan 2019
- Primary completion20 Nov 2020
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buse KILINÇ, Pamukkale University
- Investigators
- Buse KILINÇ, PT.MSc., Principal investigator, Pamukkale UniversityNilüfer ÇETİŞLİ-KORKMAZ, PT.PhD.Prof., Study director, Pamukkale UniversityLevent S. BIR, MD.PhD.Prof., Study chair, Pamukkale UniversityAhmet D. MARANGOZ, MD., Study chair, Klinikum StuttgartHande ŞENOL, Assist.Prof., Study chair, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906693
- Sponsor's protocol ID
- 60116787-020/45991
- Other IDs
- 2019SABE021
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31118162Bhatia 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.
PubMed 29193359Louis 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.
PubMed 25952960
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study - The Quality of Life in Individuals With Parkinson's Disease: Is it Related to Functionality and Tremor Severity?
- ClinicalTrials.gov ID
- NCT05906693
- Acronym / sponsor ID
- 60116787-020/45991
- Conditions
- Parkinson Disease, Tremor, Functionality
- Keywords
- Quality of Life, Upper Limb Functionality, Tremor, Electromyography, Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with Parkinson Disease were included in the study
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Who were with any other neurologic or orthopedic or rheumatologic disease affecting the upper extremity
- Using antidepressants
- Having vision loss
- Deep brain stimulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of lifeParkinson's Disease Quality of Life Questionnaire (PDQ-39) | Other | – |
| Upper limb functionalityNine-Hole Peg Test | Other | – |
| Grip and pinch strengthDynamometer | Other | – |
| Tremor amplitudeElectromyography | Other | – |
| Depression and anxiety levelsHospital Anxiety and Depression Scale | Other | – |
| Clinical manifestationsThe Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale | Other | – |
Primary outcome
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.
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.
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Time frame: 1 year
Used to assess the quality of life of Parkinson's patients
Electromyography
Time frame: 1 year
Used to assess the tremor amplitude of Parkinson's patients
Nine-Hole Peg Test
Time frame: 1 year
Used to assess the upper limb functionality of Parkinson's patients
Dynamometer
Time frame: 1 year
Used to assess the grip and pinch strength of Parkinson's patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Background: PubMed 31118162Kuhlman 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.
- Background: PubMed 29193359Bhatia 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.
- Background: PubMed 25952960Louis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Buse KILINÇ, PT.MSc. principal investigator
Pamukkale University
Nilüfer ÇETİŞLİ-KORKMAZ, PT.PhD.Prof. study director
Pamukkale University
Levent S. BIR, MD.PhD.Prof. study chair
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Tremor, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05906693, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.