Movement Disorders (Incl Parkinsonism)NCT06283043
Effect of Motor Function, Depression and Sleep Quality on Attention in Parkinson's Disease
An observational study of Movement Disorders (Incl Parkinsonism) and Parkinsonian Disorders, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Our study was planned to analyze motor function, endurance and sleep attention information in Parkinson's patients with detailed and objective measurements. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Movement Disorders (Incl Parkinsonism), Parkinsonian Disorders, Attention Impaired
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 5 Mar 2024
- 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
- Adult, Older adult
Study population: Parkinson Diseases and Healty Control
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Our study was planned to analyze motor function, endurance and sleep attention information in Parkinson's patients with detailed and objective measurements.
Read the detailed description
Parkinson's Disease (PD) is a neurodegenerative disease that occurs with the loss of dopaminergic neurons in the basal ganglia (BG) and subsequently affects multiple brain regions. There are studies that evaluate executive functions rather than cognitive functions in Parkinson's patients. However, objective evaluations of the attention parameter are quite rare. Accordingly, our study was planned to examine the effects of motor function, depression and sleep on attention in Parkinson's patients with detailed and objective measurements. Parkinson's patients (n=27) and healthy controls (n=27) aged between 40-85 will be included in the study. Balance evaluation of the individuals participating in the study was carried out by functional reaching test, one-leg standing test and Berg balance scale; Endurance with a 30-second sit-and-stand test; reaction time; with mobile application; muscle strength by hand dynamometer; functional mobility with time up and go test; walking speed, with 10 m walk test; attention with the P300 device; depression, with the Beck depression scale; Sleep quality will be assessed with the Pittsburg sleep questionnaire. At the end of the study, the effects of motor functions, sleep and depression on attention will be examined and compared with healthy controls.
- Conditions
- Movement Disorders (Incl Parkinsonism), Parkinsonian Disorders, Attention Impaired, Movement Disorders, Functional
- Keywords
- Parkinson, Attention, motor function, sleep
- Medical subject headings
- Movement Disorders, Parkinsonian Disorders, Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TUG
functional mobility
Measured: second, day 1, Values over 12 seconds indicate the risk of falling
10 m walking test
walking speed
Measured: second, day 1, lower results indicate better values, higher results indicate worse results
30 sec sit-stand test
endurance
Measured: again,day 1, higher results indicate better values, lower results indicate worse results
berg balance test
balance
Measured: score, day 1, The score is between 0-56. A high total score indicates a good result
one leg stance test
balance
Measured: second, day 1, higher results indicate better values, lower results indicate worse results
functional reach test
balance
Measured: centimeter, day 1, higher results indicate better values, lower results indicate worse results
hand dinamometer
strenght
Measured: kilogram, day 1, higher results indicate better values, lower results indicate worse results
mobil application
reaction time
Measured: second, day 1, lower results indicate better values, higher results indicate worse results
Pittsburg Sleep Quality İndex
sleep
Measured: score, day 1, The score is between 0-21. A high total score indicates a bad result.
Beck Depression
depression
Measured: score,day 1, The total score is between 0-63. A high total score indicates that the result is bad.
P300
attention
Measured: second, day 1, lower results indicate better values, higher results indicate worse results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jan 2024
- Primary completion1 Mar 2024 (estimated)
- Study completion5 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement Disorders (Incl Parkinsonism)Studies of the same condition, open and under way.
- More trials run by Inonu 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Talu, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283043
- Sponsor's protocol ID
- 2022/3749
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Motor Function, Depression and Sleep Quality on Attention in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06283043
- Acronym / sponsor ID
- 2022/3749
- Conditions
- Movement Disorders (Incl Parkinsonism), Parkinsonian Disorders, Attention Impaired, Movement Disorders, Functional
- Keywords
- Parkinson, Attention, motor function, sleep
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 5 Mar 2024 (estimated)
- First posted
- 28 Feb 2024 (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.
Our study was planned to analyze motor function, endurance and sleep attention information in Parkinson's patients with detailed and objective measurements.
Detailed description
Parkinson's Disease (PD) is a neurodegenerative disease that occurs with the loss of dopaminergic neurons in the basal ganglia (BG) and subsequently affects multiple brain regions. There are studies that evaluate executive functions rather than cognitive functions in Parkinson's patients. However, objective evaluations of the attention parameter are quite rare. Accordingly, our study was planned to examine the effects of motor function, depression and sleep on attention in Parkinson's patients with detailed and objective measurements. Parkinson's patients (n=27) and healthy controls (n=27) aged between 40-85 will be included in the study. Balance evaluation of the individuals participating in the study was carried out by functional reaching test, one-leg standing test and Berg balance scale; Endurance with a 30-second sit-and-stand test; reaction time; with mobile application; muscle strength by hand dynamometer; functional mobility with time up and go test; walking speed, with 10 m walk test; attention with the P300 device; depression, with the Beck depression scale; Sleep quality will be assessed with the Pittsburg sleep questionnaire. At the end of the study, the effects of motor functions, sleep and depression on attention will be examined and compared with healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Parkinson Diseases and Healty Control
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TUG
Time frame: second, day 1, Values over 12 seconds indicate the risk of falling
functional mobility
10 m walking test
Time frame: second, day 1, lower results indicate better values, higher results indicate worse results
walking speed
30 sec sit-stand test
Time frame: again,day 1, higher results indicate better values, lower results indicate worse results
endurance
berg balance test
Time frame: score, day 1, The score is between 0-56. A high total score indicates a good result
balance
one leg stance test
Time frame: second, day 1, higher results indicate better values, lower results indicate worse results
balance
functional reach test
Time frame: centimeter, day 1, higher results indicate better values, lower results indicate worse results
balance
hand dinamometer
Time frame: kilogram, day 1, higher results indicate better values, lower results indicate worse results
strenght
mobil application
Time frame: second, day 1, lower results indicate better values, higher results indicate worse results
reaction time
Pittsburg Sleep Quality İndex
Time frame: score, day 1, The score is between 0-21. A high total score indicates a bad result.
sleep
Beck Depression
Time frame: score,day 1, The total score is between 0-63. A high total score indicates that the result is bad.
depression
P300
Time frame: second, day 1, lower results indicate better values, higher results indicate worse results
attention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Movement Disorders (Incl Parkinsonism) and Parkinsonian Disorders, run by Inonu 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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?
Results are not available in the source record.
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?
TUG (time frame: second, day 1, Values over 12 seconds indicate the risk of falling). The study lists 11 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 28 Feb 2024.