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

NCT06416345 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

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

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Erwin EH van Wegen, PhD · Amsterdam UMC, location VUmc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-22
Primary Completion
2027-12-01
Completion
2027-12-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06416345 on ClinicalTrials.gov