Opals for Parkinson's (NCT06519279)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 2 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.