Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cue2Walk, Usual Care.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Freezing of gait (FoG) is one of the most common and disabling motor symptoms of Parkinson's disease and is associated with poorer quality of life. However, current pharmacological or even surgical treatments do not address FoG adequately and innovative rehabilitation strategies are needed. Cueing is a proven strategy to overcome FoG episodes and an essential part in the management of FoG. The Cue2Walk, a Medical Device Class I CE-certified leg-worn device, addresses the debilitating effects of FoG episodes at home with 'smart cueing' by combining automatic detection of a freezing episode with manual or automatic rhythmic cues (auditory or vibro-tactile). This study aims to investigate the (cost-)effectiveness of the Cue2Walk device as compared to usual care. This study is a multicenter randomized clinical trial with 2 parallel groups (24-week intervention group and 24-week 'waiting list' group). After 24 weeks, an 8-week naturalistic follow-up will be implemented for the intervention group, while participants in the waiting list group will also receive the intervention, but for 8 weeks. Frequently repeated assessment of outcomes measures will be conducted.
Interventions
- 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
Primary outcome measures
- Self-reported quality of life [Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- General health-related quality of life [Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Time in Freezing of Gait [Time frame: Continuously from baseline (week 0) up to week 32]
Secondary outcome measures (12)
- Falls Efficacy [Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Numbers of falls [Time frame: Weekly from baseline (week 0) up to week 32]
- Freezing of Gait severity [Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Freezing of Gait severity [Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Independence in Activities of Daily Living [Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Motor Aspects of Experiences of Daily Living [Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Daily mobility [Time frame: Continuously from baseline (week 0) up to week 32]
- Mood [Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Gait-Specific Attentional Profile [Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Acceptance of Illness [Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Caregiver burden [Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Patient experiences [Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
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
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Netherlands · 2 centers
- Radboudumc — Nijmegen
- Amsterdam UMC, location VUmc — Amsterdam
Identifiers
NCT: NCT06416345 · NL86310.018.24