Health TrialsbyHealthPanel

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

ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAmsterdam UMC, location VUmc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cue2Walk

    Device

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

  • Usual Care

    Other intervention

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

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Self-reported quality of life

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

Time frame
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
2

General health-related quality of life

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

Time frame
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
3

Time in Freezing of Gait

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

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

Secondary outcomes

1

Falls Efficacy

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

Time frame
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
2

Numbers of falls

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

Time frame
Weekly from baseline (week 0) up to week 32
3

Freezing of Gait severity

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

Time frame
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
4

Freezing of Gait severity

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

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

Other outcomes

1

Resource Utilization

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amsterdam UMC, location VUmc

Lead sponsor

Radboud University Medical Center

Collaborator

Source ClinicalTrials.gov
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