RecruitingNot ApplicableNCT06416345

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


Sponsor

Amsterdam UMC, location VUmc

Enrollment

84 participants

Start Date

Aug 22, 2025

Study Type

INTERVENTIONAL

Conditions

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

Inclusion Criteria5

  • 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 Criteria5

  • 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)

Interventions

DEVICECue2Walk

24 weeks of using of the Cue2Walk device in the own living environment + 8 weeks of naturalistic follow-up

OTHERUsual Care

24 weeks of receiving usual care + 8 weeks of using of the Cue2Walk device in the own living environment


Locations(2)

Radboudumc

Nijmegen, Gelderland, Netherlands

Amsterdam UMC, location VUmc

Amsterdam, North Holland, Netherlands

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NCT06416345


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