NCT06416345 Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease
| NCT ID | NCT06416345 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Amsterdam UMC, location VUmc |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2025-08-22 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2025-08-22 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The majority of people with Parkinson's disease incur Freezing of Gait (FoG), which is not addressed adequately by medication. Cueing is a proven strategy to overcome FoG. The Cue2Walk is a device with automated detection of FoG and provision of rhythmic cues. In this study, the (cost-)effectiveness of the Cue2Walk device as compared to usual care is investigated.
Eligibility 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)
Contact & Investigator
Erwin EH van Wegen, PhD
PRINCIPAL INVESTIGATOR
Amsterdam UMC, location VUmc
Frequently Asked Questions
Who can join the NCT06416345 clinical trial?
This trial is open to participants of all sexes, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06416345 currently recruiting?
Yes, NCT06416345 is actively recruiting participants. Contact the research team at e.vanwegen@amsterdamumc.nl for enrollment information.
Where is the NCT06416345 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands, Amsterdam, Netherlands.
Who is sponsoring the NCT06416345 clinical trial?
NCT06416345 is sponsored by Amsterdam UMC, location VUmc. The principal investigator is Erwin EH van Wegen, PhD at Amsterdam UMC, location VUmc. The trial plans to enroll 84 participants.
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