Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease
Recruiting
N/AInterventional Study
Parkinson Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
84 (estimated)
Sponsor
Amsterdam UMC, location VUmc · Other
Who this trial is looking for
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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.
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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
Exclusi…
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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