Predict falls due to freezing
- Trial ID
- NCT07386015
- Official Title
- FREEZE-Path Cohort: Etiology-Phenotype-Outcome Pathway Study on Freezing of Gait (FOG)
- Goal
- Predict falls due to freezing
- Status
- RECRUITING
- Sponsor
- Tianjin Huanhu Hospital
- Study Type
- OBSERVATIONAL
- Enrollment
- 700 participants
- Conditions
- Freezing of Gait, Parkinson's Disease, Parkinsonism, Vascular Parkinsonism, Idiopathic Normal Pressure Hydrocephalus (INPH)
- Interventions
- Observational Data Collection
Summary For Families
The goal is to unravel why freezing of gait happens and how different causes and movement patterns predict who gets worse, so clinicians can identify distinct FOG subtypes and better predict outcomes. To do that, researchers will collect observational data from up to 700 people, including gait and balance tests, video and speech recordings, and clinical measures, then map etiology, phenotype, and outcome links without testing a treatment. Adults 30 to 85 with Parkinson's disease or related parkinsonian disorders who have freezing or other gait or balance problems and can complete assessments and give consent are eligible, while people with very severe dementia (MMSE < 10), major recent medical events, severe psychiatric or medical issues affecting gait safety, inability to follow up, or refusal of video/speech recording are excluded.
Locations
- Tianjin Huanhu Hospital, Tianjin, Tianjin Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Observational Data Collection. The goal is to unravel why freezing of gait happens and how different causes and movement patterns predict who gets worse, so clinicians can identify distinct FOG subtypes and better predict outcomes. To do that, researchers will collect observational data from up to 700 people, including gait and balance tests, video and speech recordings, and clinical measures, then map etiology, phenotype, and outcome links without testing a treatment. Adults 30 to 85 with Parkinson's disease or related parkinsonian disorders who have freezing or other gait or balance problems and can complete assessments and give consent are eligible, while people with very severe dementia (MMSE < 10), major recent medical events, severe psychiatric or medical issues affecting gait safety, inability to follow up, or refusal of video/speech recording are excluded.
- Who can participate?
- Participants must be between 30 Years and 85 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 3 years and 10 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.