Trials
Search / 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

Launched by AMSTERDAM UMC, LOCATION VUMC · May 10, 2024

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Trial Information

Current as of March 14, 2025

Not yet recruiting

Keywords

Parkinson's Disease Freezing Of Gait (Smart) Cueing Costeffectiveness

ClinConnect Summary

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 w...

Gender

ALL

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)

Trial Officials

Erwin EH van Wegen, Dr.

Principal Investigator

Amsterdam UMC, location VUmc

About Amsterdam Umc, Location Vumc

Amsterdam UMC, located at VU Medical Center (VUmc), is a leading academic medical center in the Netherlands dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on translating scientific discoveries into practical applications, Amsterdam UMC collaborates closely with researchers, healthcare professionals, and industry partners to enhance patient outcomes. The institution is committed to rigorous ethical standards and regulatory compliance, ensuring the integrity and reliability of its clinical research initiatives across various medical disciplines.

Locations

Amsterdam, Noord Holland, Netherlands

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0