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

Amsterdam UMC, location VUmc

Status: Not yet enrolling

Conditions: Parkinson Disease

Treatments: Device: Cue2Walk; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06416345

NL86310.018.24

Details and patient eligibility

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Intervention Group

Experimental group

Description:

At-home use of the Cue2Walk

Treatment:

Device: Cue2Walk

Control Group

Other group

Description:

Usual Care (+ Waiting List)

Treatment:

Other: Usual Care