Parkinson DiseaseNCT06487364
Determination of the Minimal Detectable Change of the Parkinson's Disease Questionnaire-8
An observational study of Parkinson Disease, run by Emre Şenocak at 1 site in Turkey (Türkiye).
Trial summary
This study is conducted to determine how many units of improvement the Parkinson's Disease Questionnaire-8 (PDQ-8), used to evaluate the quality of life of Parkinson's patients, should have to express a significant change in the quality of life. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Rehabilitation
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2024to 17 Sep 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Parkinson Disease
Who may be able to join
- Having regular neurology follow-up and using medicine;
- Hoehn and Yahr Scale Stage between 1-3 points;
- Mini-Mental State Assessment Score \>24 points;
Who cannot join
- Having a secondary neurological disease;
- Any surgery and/or trauma affecting the upper extremity
- Having complaints of pain before the treatment program;
- There was a change in medical treatment during the study;
- With symptoms of anxiety and depression;
- Those who use alcohol and drugs;
- Individuals with vision defects that cannot be corrected by the use of glasses and those with hearing loss
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Private Güney Hospital
Istanbul, 34230
Call Center, Personel of Call Center, +90 212 645 16 16, bilgiislem@guneyhastanesi.com
Adem Aktürk, PhD (Also: Medical Doctor), +90 533 310 23 15, aakturk@gelisim.edu.tr
About this study
Official title: Determination of the Minimal Detectable Change and Minimum Clinically Important Change Score of the Parkinson's Disease Questionnaire-8
This study is conducted to determine how many units of improvement the Parkinson's Disease Questionnaire-8 (PDQ-8), used to evaluate the quality of life of Parkinson's patients, should have to express a significant change in the quality of life. Patients for whom a 30-session physiotherapy program is recommended will be included in the study. Patients will be asked to express the change in their quality of life at the end of treatment. The PDQ-8 survey and Global Rating of Patient-Perceived Changes (GRP-PC) forms will be used to determine these changes. Evaluations will be repeated at the beginning of the treatment program and at the end of the 30th session.
- Conditions
- Parkinson Disease
- Being tested
- Rehabilitation
- Keywords
- Parkinson, Minimal Detectable Change, Minimal Clinically Important Difference, Parkinson Disease Questionnaire-8
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
A routine physical therapy program prescribed by a specialist physician and physiotherapist will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy Group | There will be only one group in the study. Patients will only be applied to the physiotherapy program recommended by the specialist physician and physiotherapist. It is not possible to apply any additional treatment within the scope of the study. Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkinson Disease Questionnaire-8
It is an 8-item form used to assess the quality of life in Parkinson's disease.
Measured: 7 days before the Physiotherapy session
Parkinson Disease Questionnaire-8
It is an 8-item form used to assess the quality of life in Parkinson's disease.
Measured: First day of the physiotherapy session
Parkinson Disease Questionnaire-8
It is an 8-item form used to assess the quality of life in Parkinson's disease.
Measured: 6 weeks (5 physiotherapy sessions for 6 weeks)
Secondary outcomes (4)
Demographic Data Form
This form was created by researchers and it consist of personal informations such as gender, education, age, body mass index, duration of disease
Measured: First day of the physiotherapy session
Modified Hoehn & Yahr Scale
It is used to determine the disease stage. It stages the disease between 1 and 5 points. As the stage progresses, disability also increases.
Measured: First day of the physiotherapy session
Unified Parkinson's Disease Rating Scale (UPDRS)
It can assess Parkinson's disease with its different clinical features, including motor and non-motor. It consists of 4 subsections and 55 items in total. This study will use part III of the UPDRS score (between subsections 3.1 and 3.18)
Measured: First day of the physiotherapy session
Global Rating of Patient-Perceived Changes (GRP-PC)
GRP-PC will used to assess patient-perceived hand dexterity changes after the routine intervention. The patient will first asked, "Has your hand dexterity changed compared to when you did not receive interventions?". If the answer is no, the person will given a score of 0 (i.e. no change). In the case of positive response, the patient will asked, "How much better or worse is your hand dexterity" and the patient response will scored on the following 14-point Likert scale: +7 (very much better), +6 (much better), +5 (better), +4 (relatively better), +3 (somewhat better), +2 (a little better), +1 (very little better), -1 (very little worse), -2 (a little worse), -3 (somewhat worse), -4 (relatively worse), -5 (worse), -6 (much worse), and -7 (very much worse).
Measured: 6 weeks (5 physiotherapy sessions for 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start13 May 2024
- Primary completion17 Jan 2025
- Study completion17 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Emre Şenocak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emre Şenocak, Karadeniz Technical University
- Investigators
- Murat Emirzeoğlu, PhD, Study chair, Karadeniz Technical UniversityAdem Aktürk, PhD, Study chair, İstanbul Gelişim UniversityTuğba Eyigürbüz, PhD, Study chair, Bağcılar Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487364
- Sponsor's protocol ID
- 2024/78
- Status last verified
- Mar 2025
- First submitted
- 27 Jun 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Minimal Detectable Change and Minimum Clinically Important Change Score of the Parkinson's Disease Questionnaire-8
- ClinicalTrials.gov ID
- NCT06487364
- Acronym / sponsor ID
- 2024/78
- Conditions
- Parkinson Disease
- Keywords
- Parkinson, Minimal Detectable Change, Minimal Clinically Important Difference, Parkinson Disease Questionnaire-8
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Emre ŞenocakUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Sep 2025 (estimated)
- First posted
- 5 Jul 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.
This study is conducted to determine how many units of improvement the Parkinson's Disease Questionnaire-8 (PDQ-8), used to evaluate the quality of life of Parkinson's patients, should have to express a significant change in the quality of life. Patients for whom a 30-session physiotherapy program is recommended will be included in the study. Patients will be asked to express the change in their quality of life at the end of treatment. The PDQ-8 survey and Global Rating of Patient-Perceived Changes (GRP-PC) forms will be used to determine these changes. Evaluations will be repeated at the beginning of the treatment program and at the end of the 30th session.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy Group | – | Other: RehabilitationThere will be only one group in the study. Patients will only be applied to the physiotherapy program recommended by the specialist physician and physiotherapist. It is not possible to apply any additional treatment within the scope of the study. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson Disease
Key inclusion criteria (3 listed)
- Having regular neurology follow-up and using medicine;
- Hoehn and Yahr Scale Stage between 1-3 points;
- Mini-Mental State Assessment Score \>24 points;
Key exclusion criteria (7 listed)
- Having a secondary neurological disease;
- Any surgery and/or trauma affecting the upper extremity
- Having complaints of pain before the treatment program;
- There was a change in medical treatment during the study;
- With symptoms of anxiety and depression;
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 |
|---|---|---|
| RehabilitationA routine physical therapy program prescribed by a specialist physician and physiotherapist will be applied. | Other | Physiotherapy Group |
Primary outcome
Parkinson Disease Questionnaire-8
Time frame: 7 days before the Physiotherapy session
It is an 8-item form used to assess the quality of life in Parkinson's disease.
Parkinson Disease Questionnaire-8
Time frame: First day of the physiotherapy session
It is an 8-item form used to assess the quality of life in Parkinson's disease.
Parkinson Disease Questionnaire-8
Time frame: 6 weeks (5 physiotherapy sessions for 6 weeks)
It is an 8-item form used to assess the quality of life in Parkinson's disease.
4 secondary outcomes
Demographic Data Form
Time frame: First day of the physiotherapy session
Modified Hoehn & Yahr Scale
Time frame: First day of the physiotherapy session
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: First day of the physiotherapy session
Global Rating of Patient-Perceived Changes (GRP-PC)
Time frame: 6 weeks (5 physiotherapy sessions for 6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Murat Emirzeoğlu, PhD study chair
Karadeniz Technical University
Adem Aktürk, PhD study chair
İstanbul Gelişim University
Tuğba Eyigürbüz, PhD study chair
Bağcılar Education and Research Hospital
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, run by Emre Şenocak 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emre Şenocak, PhD (+90 553 569 56 92, emre.senocak@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parkinson Disease Questionnaire-8 (time frame: 7 days before the Physiotherapy session). 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 5 Mar 2025.