Rehabilitation measures meaningful daily improvements
- Trial ID
- NCT06487364
- Official Title
- Determination of the Minimal Detectable Change and Minimum Clinically Important Change Score of the Parkinson's Disease Questionnaire-8
- Goal
- Rehabilitation measures meaningful daily improvements
- Status
- RECRUITING
- Sponsor
- Emre Şenocak
- Study Type
- OBSERVATIONAL
- Enrollment
- 39 participants
- Conditions
- Parkinson Disease
- Interventions
- Rehabilitation
Summary For Families
The goal is to figure out how much change in the PDQ-8 quality of life score counts as a real, measurable difference and as a meaningful improvement for people with Parkinson's. Participants will take part in a rehabilitation program and complete the PDQ-8 before and after treatment, so researchers can calculate the minimal detectable change and the minimum clinically important change, with the PDQ-8 measuring Parkinson's-related daily life and wellbeing. The study is looking for people aged 40 to 80 with mild to moderate Parkinson's (Hoehn and Yahr stages 1,3), on stable Parkinson's medications with regular neurology follow-up, normal cognition (MMSE >24), and without other neurological disease, recent upper limb surgery or ongoing pain, active mood disorders, substance use, or uncorrectable vision or hearing loss.
Locations
- Private Güney Hospital, Istanbul, Turkey (Türkiye)
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Rehabilitation. The goal is to figure out how much change in the PDQ-8 quality of life score counts as a real, measurable difference and as a meaningful improvement for people with Parkinson's. Participants will take part in a rehabilitation program and complete the PDQ-8 before and after treatment, so researchers can calculate the minimal detectable change and the minimum clinically important change, with the PDQ-8 measuring Parkinson's-related daily life and wellbeing. The study is looking for people aged 40 to 80 with mild to moderate Parkinson's (Hoehn and Yahr stages 1,3), on stable Parkinson's medications with regular neurology follow-up, normal cognition (MMSE >24), and without other neurological disease, recent upper limb surgery or ongoing pain, active mood disorders, substance use, or uncorrectable vision or hearing loss.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 8 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.