Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease
Recruiting · NCT06416345 · Interventional (participants receive a specific treatment) · Lead sponsor: Amsterdam UMC, location VUmc
View the official record on ClinicalTrials.gov →Interventions studied
Cue2WalkUsual Care
What this trial is about
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 can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
2 locations listed.
- Radboudumc - Nijmegen, Gelderland, Netherlands
- Amsterdam UMC, location VUmc - Amsterdam, North Holland, Netherlands