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NCT Number: NCT06416345

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

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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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc, Nijmegen, Gelderland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cue2Walk

Device

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

Usual Care

Other

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

Primary outcomes

  1. Self-reported quality of life

    Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

    Self-reported quality of life will be determined using the Parkinson's Disease Questionnaire (PDQ-39)

  2. General health-related quality of life

    Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

    General health-related quality of life will be determined using the EuroQol 5 Dimensions 5 Level Survey (EQ-5D-5L)

  3. Time in Freezing of Gait

    Time frame: Continuously from baseline (week 0) up to week 32

    Time in Freezing of Gait (i.e. frequency and duration of FoG) will be determined by the Cue2Walk medical device

Secondary outcomes

  1. Falls Efficacy

    Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

    The level of concern about falling during various activities will be determined by the Falls Efficacy Scale International (FES-I)

  2. Numbers of falls

    Time frame: Weekly from baseline (week 0) up to week 32

    The number of falls and near-falls will be determined with a weekly diary

  3. Freezing of Gait severity

    Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

    Freezing of Gait severity will be determined by the New Freezing of Gait Questionnaire (NFOG-Q)

  4. Freezing of Gait severity

    Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

    Freezing of Gait severity will be determined by the Patient Reported Outcomes for Freezing of Gait (PRO-FOG)

  5. Independence in Activities of Daily Living

    Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

    Independence in Activities of Daily Living will be determined by the Nottingham Extended Activities of Daily Living Index (NEADL)

  6. Motor Aspects of Experiences of Daily Living

    Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

    Motor Aspects of Experiences of Daily Living will be determined by MDS-UPDRS part II

  7. Daily mobility

    Time frame: Continuously from baseline (week 0) up to week 32

    Daily mobility will be determined by the Cue2Walk step count

  8. Mood

    Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

    Mood will be determined by Hospital Anxiety and Depression Scale (HADS)

  9. Gait-Specific Attentional Profile

    Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

    Gait-Specific Attentional Profile will be determined by the Gait-Specific Attentional Profile questionnaire (G-SAP)

  10. Acceptance of Illness

    Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

    Acceptance of illness will be determined by the Chronic Illness Acceptance Questionnaire (CIAQ)

  11. Caregiver burden

    Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

    Caregiver burden will be determined by Zarit's Burden Interview Short Form (ZBI-12)

  12. Patient experiences

    Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

    We will use patient reported experience measures (PREMS) to quantify patient experiences regarding the care they receive during the intervention phase and we will record user experiences

Other outcomes

  1. Resource Utilization

    Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24)

    For the economic evaluation, resource utilization will be determined by a cost questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Erwin EH van Wegen, PhD

CONTACT

[email protected]

020-4440461

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • Radboud University Medical Center

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 16, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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