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RecruitingNCT06416345

Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease

Trial Parameters

ConditionParkinson Disease
SponsorAmsterdam UMC, location VUmc
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment84
SexALL
Min AgeN/A
Max AgeN/A
Start Date2025-08-22
Completion2027-12-01
Interventions
Cue2WalkUsual Care

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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)

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