Clinical trial NCT06416345: Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease
Official title: Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Freezing of Gait
(Smart) Cueing
Costeffectiveness
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2024-05-16
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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)

Primary outcomes:
measure: Self-reported quality of life
timeFrame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
measure: General health-related quality of life
timeFrame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
measure: Time in Freezing of Gait
timeFrame: Continuously from baseline (week 0) up to week 32
Secondary outcomes:
measure: Falls Efficacy
timeFrame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
measure: Numbers of falls
timeFrame: Weekly from baseline (week 0) up to week 32
measure: Freezing of Gait severity
timeFrame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
measure: Freezing of Gait severity
timeFrame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
measure: Independence in Activities of Daily Living
timeFrame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
measure: Motor Aspects of Experiences of Daily Living
timeFrame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
measure: Daily mobility
timeFrame: Continuously from baseline (week 0) up to week 32
measure: Mood
timeFrame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
measure: Gait-Specific Attentional Profile
timeFrame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
measure: Acceptance of Illness
timeFrame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
measure: Caregiver burden
timeFrame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
measure: Patient experiences
timeFrame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Other outcomes:
measure: Resource Utilization
timeFrame: Baseline (week 0), week 8, week 16, Post-intervention (week 24)
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUmc
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Erwin EH van Wegen, Dr.
role: PRINCIPAL_INVESTIGATOR
References: