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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2027-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

At-home use of the Cue2Walk

Group Type EXPERIMENTAL

Cue2Walk

Intervention Type DEVICE

24 weeks of using of the Cue2Walk device in the own living environment + 8 weeks of naturalistic follow-up

Control Group

Usual Care (+ Waiting List)

Group Type OTHER

Usual Care

Intervention Type OTHER

24 weeks of receiving usual care + 8 weeks of using of the Cue2Walk device in the own living environment

Interventions

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Cue2Walk

24 weeks of using of the Cue2Walk device in the own living environment + 8 weeks of naturalistic follow-up

Intervention Type DEVICE

Usual Care

24 weeks of receiving usual care + 8 weeks of using of the Cue2Walk device in the own living environment

Intervention Type OTHER

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No