Characterize freezing of gait episodes
- Trial ID
- NCT06519279
- Official Title
- An International Multimodal Protocol for Assessing Freezing of Gait in Individuals Living with Parkinson's Disease
- Goal
- Characterize freezing of gait episodes
- Status
- RECRUITING
- Sponsor
- Tel-Aviv Sourasky Medical Center
- Study Type
- OBSERVATIONAL
- Enrollment
- 20 participants
- Conditions
- PD - Parkinson's Disease
- Interventions
- Opals, Axivity
Summary For Families
The project aims to improve detection and measurement of freezing of gait, the sudden brief inability to step that many people with Parkinson's experience. It uses small wearable motion sensors called Opal and Axivity to record detailed limb and trunk movement and automatically identify and quantify freezing episodes during clinic tests and in daily life, the sensors only collect movement data and do not interact with levodopa or other drugs, though participants may be asked to briefly delay their morning Parkinson's medication. Adults 18 and older with idiopathic Parkinson's who can walk 10 meters unaided, have no deep brain stimulator, and have had stable Parkinson's meds for at least 4 weeks can join, with those who have freezing needing a score of 1 or more on the New Freezing of Gait Questionnaire; recent major cardiac events, active cancer treatment, certain severe medical or psychiatric conditions, pregnancy, or unwillingness to delay morning meds exclude someone.
Locations
- Tel Aviv Saurasky Medical Center, Tel Aviv, Israel
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Opals. The project aims to improve detection and measurement of freezing of gait, the sudden brief inability to step that many people with Parkinson's experience. It uses small wearable motion sensors called Opal and Axivity to record detailed limb and trunk movement and automatically identify and quantify freezing episodes during clinic tests and in daily life, the sensors only collect movement data and do not interact with levodopa or other drugs, though participants may be asked to briefly delay their morning Parkinson's medication. Adults 18 and older with idiopathic Parkinson's who can walk 10 meters unaided, have no deep brain stimulator, and have had stable Parkinson's meds for at least 4 weeks can join, with those who have freezing needing a score of 1 or more on the New Freezing of Gait Questionnaire; recent major cardiac events, active cancer treatment, certain severe medical or psychiatric conditions, pregnancy, or unwillingness to delay morning meds exclude someone.
- Who can participate?
- Participants must be at least 18 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 1 year and 2 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.