Predict falls by assessing balance
- Trial ID
- NCT07148700
- Official Title
- Which Tools Better Predict Fall Risk in Parkinson's Disease: A Comparative Study of Objective, Self-Reported, and Functional Balance Assessment
- Goal
- Predict falls by assessing balance
- Status
- RECRUITING
- Sponsor
- Bezmialem Vakif University
- Study Type
- OBSERVATIONAL
- Enrollment
- 40 participants
- Conditions
- PARKINSON DISEASE (Disorder), Parkinson, Parkinson s Disease, Parkinson Disease, Parkinson Disease (PD)
Summary For Families
The goal is to find which way of measuring balance and falls best predicts future fall risk in people with mild to moderate Parkinson's (Hoehn and Yahr stages 1 to 3). To do that, researchers will compare objective device-based measures like gait and sway recordings, self-reported tools such as fall history and balance-confidence questionnaires, and practical functional balance tests that watch you perform standing and walking tasks, with measurements taken while participants are on their usual stable dopaminergic medications. They're enrolling people 40 to 80 years old with Parkinson's who are on stable dopaminergic treatment, have a Mini-Mental State Exam score above 24, and no other neurological disorders. People with major vision, hearing, heart or lung problems, recent rehabilitation, severe communication issues, or clinical instability in the past month are not eligible.
Locations
- Bezmialem Vakif University, Istanbul, Eyup, Turkey (Türkiye)
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to find which way of measuring balance and falls best predicts future fall risk in people with mild to moderate Parkinson's (Hoehn and Yahr stages 1 to 3). To do that, researchers will compare objective device-based measures like gait and sway recordings, self-reported tools such as fall history and balance-confidence questionnaires, and practical functional balance tests that watch you perform standing and walking tasks, with measurements taken while participants are on their usual stable dopaminergic medications. They're enrolling people 40 to 80 years old with Parkinson's who are on stable dopaminergic treatment, have a Mini-Mental State Exam score above 24, and no other neurological disorders. People with major vision, hearing, heart or lung problems, recent rehabilitation, severe communication issues, or clinical instability in the past month are not eligible.
- 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 4 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.