Cue2Walk for Parkinson's (NCT06416345)
Can wearable cues reduce 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
- Can wearable cues reduce freezing
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Amsterdam UMC, location VUmc
- Study Type
- INTERVENTIONAL
- Enrollment
- 84 participants
- Conditions
- Parkinson Disease
- Interventions
- Cue2Walk, Usual Care
- Registry Record Last Updated
- 2026-03-16 (4 months ago)
- Estimated Commitment
- Commitment level unclear from the registry data — ask the study coordinator what taking part involves.
Summary For Families
Cue2Walk automatically detects a freezing episode and then gives rhythmic sounds or vibrations, either automatically or when you trigger them, to help restart walking; it is an approved, wearable medical device. They are looking for people diagnosed with Parkinson's who have daily freezing, are in the middle stages of the condition (stage 2 to 4 on a common scale), are on a stable medication or stable deep brain stimulation setting, can walk five minutes without another person’s help, do not already use a personal cueing device, and do not have major thinking problems that would prevent learning to use the device (people scoring under 16 on a brief thinking test are excluded). Participants are randomly assigned to use the device for 24 weeks or to a 24-week waiting list, with frequent outcome checks and a short follow-up period.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Disease stage: Hoehn and Yahr stage 2 to 4
- Medication dose: Must be on a stable dose of Parkinson's medication (criteria text: "* Stable medication regime and/or DBS settings as determined by the treating neurologist")
- Thinking test (MoCA): MoCA memory and thinking score of at least 16 (criteria text: "(Montreal Cognitive Assessment (MoCA) Score \<16)")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial requires Hoehn and Yahr stage 2 to 4.
- This trial requires a MoCA thinking-test score of at least 16.
Locations
- Radboudumc, Nijmegen, Gelderland, Netherlands
- Amsterdam UMC, location VUmc, Amsterdam, North Holland, Netherlands
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT06416345. It is the one about "Can wearable cues reduce freezing". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take?
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another. Ask the coordinator to confirm it still applies.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Cue2Walk. Cue2Walk automatically detects a freezing episode and then gives rhythmic sounds or vibrations, either automatically or when you trigger them, to help restart walking; it is an approved, wearable medical device. They are looking for people diagnosed with Parkinson's who have daily freezing, are in the middle stages of the condition (stage 2 to 4 on a common scale), are on a stable medication or stable deep brain stimulation setting, can walk five minutes without another person’s help, do not already use a personal cueing device, and do not have major thinking problems that would prevent learning to use the device (people scoring under 16 on a brief thinking test are excluded). Participants are randomly assigned to use the device for 24 weeks or to a 24-week waiting list, with frequent outcome checks and a short follow-up period.
- 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?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; 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 2 years and 3 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.