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