Wearable cues reduce daily freezing
- Trial ID
- NCT06416345
- Official Title
- Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease
- Goal
- Wearable cues reduce daily freezing
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Amsterdam UMC, location VUmc
- Study Type
- INTERVENTIONAL
- Enrollment
- 84 participants
- Conditions
- Parkinson Disease
- Interventions
- Cue2Walk, Usual Care
Summary For Families
The goal is to reduce daily freezing of gait and see if an automated cueing system is more effective and cost efficient than usual care. Cue2Walk is a wearable system that automatically detects freezing episodes and delivers timed external cues, like rhythmic sounds or vibrations, to help restart and regularize stepping; it is meant to work alongside your current treatments and does not replace levodopa or DBS. The trial seeks people with Parkinson's diagnosed by UK Brain Bank criteria who have daily freezing, are Hoehn and Yahr stage 2 to 4, have stable medication or DBS settings, and can walk five minutes unassisted. People who already use a personal cueing device, have had prior Cue2Walk use, are in another study, or have cognitive impairment preventing understanding instructions (MoCA score under 16) are excluded.
Locations
- Radboudumc, Nijmegen, Gelderland, Netherlands
- Amsterdam UMC, location VUmc, Amsterdam, North Holland, Netherlands
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Cue2Walk. The goal is to reduce daily freezing of gait and see if an automated cueing system is more effective and cost efficient than usual care. Cue2Walk is a wearable system that automatically detects freezing episodes and delivers timed external cues, like rhythmic sounds or vibrations, to help restart and regularize stepping; it is meant to work alongside your current treatments and does not replace levodopa or DBS. The trial seeks people with Parkinson's diagnosed by UK Brain Bank criteria who have daily freezing, are Hoehn and Yahr stage 2 to 4, have stable medication or DBS settings, and can walk five minutes unassisted. People who already use a personal cueing device, have had prior Cue2Walk use, are in another study, or have cognitive impairment preventing understanding instructions (MoCA score under 16) are excluded.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 2 years and 3 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.