ParkinsonNCT05872646
The Effect of Cognitive Functions on Upper Extremity Functionality in Parkinson's Patients
A study testing clinical assessment in people with Parkinson and Cognitive Impairment, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's Disease (PD), first described by James Parkinson in 1817, is a progressive movement disorder that develops mainly as a result of the destruction of nigrostriatal dopaminergic neurons. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson, Cognitive Impairment, Upper Extremity Problem
- What is being tested?
- clinical assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2018to 10 Mar 2023
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a diagnosis of Parkinson's Disease.
- Not having hearing and vision problems.
- To be able to take the commands required for the manual dexterity tests.
- Agree to participate in the study.
Who cannot join
- Having undergone musculoskeletal surgery for the upper extremity.
- Having vision and hearing problems.
- Having an additional disease that may affect cognitive tests.
Trial locations and contacts
1 site in 1 country.
About this study
Parkinson's Disease (PD), first described by James Parkinson in 1817, is a progressive movement disorder that develops mainly as a result of the destruction of nigrostriatal dopaminergic neurons. The aim of our study is to determine the effect of cognitive functions on upper extremity functionality in individuals with Parkinson's Disease.
Read the detailed description
Parkinson's Disease (PD), first described by James Parkinson in 1817, is a progressive movement disorder that develops mainly as a result of the destruction of nigrostriatal dopaminergic neurons. Involvement of nigrostriatal dopaminergic neurons is associated with the motor manifestations of the disease. The most common of these symptoms are; resting tremor, bradykinesia, rigidity and balance disorder. However, non-motor symptoms related to the involvement of nervous system structures other than the dopaminergic nigrostriatal system can be observed in PD. However, due to the predominance of motor symptoms in PD, it took many years to notice cognitive changes. Traditionally, cognitive impairments in PD have been expected to occur in the advanced stages of the disease. However, cognitive impairments in the early stages are reported in approximately 30-35% of patients. Cognitive dysfunction is defined in PD, ranging from mild impairments in certain cognitive domains to severe dementia. Cognitive impairment primarily affects executive and visuospatial functions, and memory is secondarily affected.
Executive functions are higher cognitive processes that use and modify information from many cortical sensory systems in the fore and hindbrain areas to modulate and teach behavior. The frontal cortex, especially the prefrontal cortex and its striatal connections are very important neuroanatomical regions for executive functions. The relationship between the effects of cognition and motor performance and parameters in groups such as the elderly, PD and Alzheimer's patients in which these centers are affected has been an issue that has attracted the attention of many researchers. Most of the studies have focused on the lower extremity performance of cognition. However , it has been reported that cognition has positive effects on upper extremity performance and early acquired upper extremity skills have positive effects on cognitive performance .
The aim of our study is to determine the effect of cognitive functions on upper extremity functionality in individuals with Parkinson's Disease.
- Being tested
- clinical assessment
- Keywords
- Parkinson, Cognitive function, Upper extremity
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical assessmentDiagnostic test
Also called modifiye hoehn yahr
clinical staging
| Study group | Role | What they receive |
|---|---|---|
| patient group | Experimental | parkınson patient group Receives: Diagnostic Test: clinical assessment |
| healthy group | Other | age-gender matched healthy group Receives: Diagnostic Test: clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Hoehn Yahr Scale
Used for clinical staging of Parkinson's disease
Measured: 1 year
Unified Parkinson's Disease Rating Scale
Used for the evaluation of clinical manifestations of Parkinson's disease
Measured: 1 year
Parkinson's Disease Questionnaire-PDQ 39
Used to assess the quality of life of Parkinson's patients
Measured: 1 year
Secondary outcomes (4)
Stroop Test
measures the selective attention ability of individuals
Measured: 1 year
Wechsler Memory Scale-Revised
To assess attention, learning, memory and working memory in individuals aged 16-89
Measured: 1 year
Dexterity Questionnaire-24
To assess manuel dexterity
Measured: 1 year
Nine Hole Peg Test
To assess manuel dexterity
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 posted24 May 2023
- Study start8 Feb 2018
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- patient and age-gender matched healthy groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dudu ŞİMŞEK, Pamukkale University
- Investigators
- DUDU ŞIMŞEK, Study chair, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872646
- Sponsor's protocol ID
- PamukkaleU-sımsek-parkınson-01
- Status last verified
- May 2023
- First submitted
- 10 Mar 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Functions on Upper Extremity Functionality in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT05872646
- Acronym / sponsor ID
- PamukkaleU-sımsek-parkınson-01
- Keywords
- Parkinson, Cognitive function, Upper extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 24 May 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.
Parkinson's Disease (PD), first described by James Parkinson in 1817, is a progressive movement disorder that develops mainly as a result of the destruction of nigrostriatal dopaminergic neurons. The aim of our study is to determine the effect of cognitive functions on upper extremity functionality in individuals with Parkinson's Disease.
Detailed description
Parkinson's Disease (PD), first described by James Parkinson in 1817, is a progressive movement disorder that develops mainly as a result of the destruction of nigrostriatal dopaminergic neurons. Involvement of nigrostriatal dopaminergic neurons is associated with the motor manifestations of the disease. The most common of these symptoms are; resting tremor, bradykinesia, rigidity and balance disorder. However, non-motor symptoms related to the involvement of nervous system structures other than the dopaminergic nigrostriatal system can be observed in PD. However, due to the predominance of motor symptoms in PD, it took many years to notice cognitive changes. Traditionally, cognitive impairments in PD have been expected to occur in the advanced stages of the disease. However, cognitive impairments in the early stages are reported in approximately 30-35% of patients. Cognitive dysfunction is defined in PD, ranging from mild impairments in certain cognitive domains to severe dementia. Cognitive impairment primarily affects executive and visuospatial functions, and memory is secondarily affected.
Executive functions are higher cognitive processes that use and modify information from many cortical sensory systems in the fore and hindbrain areas to modulate and teach behavior. The frontal cortex, especially the prefrontal cortex and its striatal connections are very important neuroanatomical regions for executive functions. The relationship between the effects of cognition and motor performance and parameters in groups such as the elderly, PD and Alzheimer's patients in which these centers are affected has been an issue that has attracted the attention of many researchers. Most of the studies have focused on the lower extremity performance of cognition. However , it has been reported that cognition has positive effects on upper extremity performance and early acquired upper extremity skills have positive effects on cognitive performance .
The aim of our study is to determine the effect of cognitive functions on upper extremity functionality in individuals with Parkinson's Disease.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patient and age-gender matched healthy groups
| Arm | Type | Receives |
|---|---|---|
| patient group | Experimental | Diagnostic Test: clinical assessmentparkınson patient group |
| healthy group | Other | Diagnostic Test: clinical assessmentage-gender matched healthy group |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having a diagnosis of Parkinson's Disease.
- Not having hearing and vision problems.
- To be able to take the commands required for the manual dexterity tests.
- Agree to participate in the study.
Key exclusion criteria (3 listed)
- Having undergone musculoskeletal surgery for the upper extremity.
- Having vision and hearing problems.
- Having an additional disease that may affect cognitive tests.
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 |
|---|---|---|
| clinical assessmentAlso: modifiye hoehn yahrclinical staging | Diagnostic test | healthy group, patient group |
Primary outcome
Modified Hoehn Yahr Scale
Time frame: 1 year
Used for clinical staging of Parkinson's disease
Unified Parkinson's Disease Rating Scale
Time frame: 1 year
Used for the evaluation of clinical manifestations of Parkinson's disease
Parkinson's Disease Questionnaire-PDQ 39
Time frame: 1 year
Used to assess the quality of life of Parkinson's patients
4 secondary outcomes
Stroop Test
Time frame: 1 year
Wechsler Memory Scale-Revised
Time frame: 1 year
Dexterity Questionnaire-24
Time frame: 1 year
Nine Hole Peg Test
Time frame: 1 year
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 24 May 2023.
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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.
DUDU ŞIMŞEK study chair
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical assessment in people with Parkinson and Cognitive Impairment, 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 4 inclusion and 3 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 24 May 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?
Modified Hoehn Yahr Scale (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2023.