Leg-worn smart cueing device to reduce freezing of gait in Parkinson's
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
Run by Amsterdam UMC, location VUmc · NCT06416345 · Data updated 2026-11-12
This tests whether a leg-worn device that automatically detects freezing of gait and gives rhythmic sound or vibration cues helps people with Parkinson's who experience daily freezing.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Locations | 2 sites (Nijmegen, Gelderland and 1 other locations) |
| Status | Recruiting |
| Started | August 22, 2025 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT06416345 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with Parkinson's disease who have daily freezing of gait, Hoehn-Yahr stage 2–4, can walk five minutes unassisted, and have stable medication or DBS settings.
✕Probably not a fit
Patients with severe cognitive impairment (MoCA <16), those already using a personal cueing device, or with comorbidities that prevent participation are less likely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter randomized trial comparing 24 weeks of use of the Cue2Walk leg-worn device, which automatically detects freezing episodes and delivers rhythmic auditory or vibrotactile cues, with usual care and a 24-week waiting-list control. Participants are randomized to the intervention or waiting-list group, with frequent repeated outcome assessments during the intervention period. After 24 weeks the intervention group has an 8-week naturalistic follow-up, while the waiting-list group receives the device for 8 weeks. The trial also collects health-economic data to determine the cost-effectiveness of the device.
Why it matters
Potential benefit: If successful, the device could reduce the frequency and duration of freezing episodes, improve mobility and quality of life, and lower related healthcare costs.
How similar studies have gone: Rhythmic cueing is an established method to overcome freezing of gait, but fully automated home devices like Cue2Walk have limited randomized long-term data and are relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Parkinson's disease according to UK Brain bank criteria * Daily Freezing of Gait * Hoehn-Yahr stage 2-4 * Stable medication regime and/or DBS settings as determined by the treating neurologist * Ability to walk 5 minutes while unassisted by another person Exclusion Criteria: * Participation in another clinical study * Use of a personal cueing device at home * Previous use of the Cue2Walk medical device * Presence of co-morbidities that would hamper participation * Cognitive impairment preventing understanding of therapeutic instructions (Montreal Cognitive Assessment (MoCA) Score \<16)
Where it's running
-
Amsterdam UMC, location VUmc
Amsterdam, North Holland, Netherlands Recruiting -
Radboudumc
Nijmegen, Gelderland, Netherlands Not yet recruiting
Study contacts
- Principal investigator: Erwin EH van Wegen, PhD — Amsterdam UMC, location VUmc
- Study coordinator: Erwin EH van Wegen, PhD
- Email: e.vanwegen@amsterdamumc.nl
- Phone: 020-4440461
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.