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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DEVICE

Cue2Walk

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

OTHER

Usual 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