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

May 17, 2024 updated by: Dr. Erwin E. H. van Wegen, Amsterdam UMC, location VUmc
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081HZ
        • Amsterdam UMC, location VUmc
        • Contact:
        • Principal Investigator:
          • Erwin EH van Wegen, Dr.
        • Sub-Investigator:
          • Matthijs van der Laan, MSc
        • Sub-Investigator:
          • Marc B. Rietberg, Dr.
        • Sub-Investigator:
          • Jorik H. Nonnekes, Dr.
        • Sub-Investigator:
          • Vincent de Groot, Prof. dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
At-home use of the Cue2Walk
Device: Cue2Walk
24 weeks of using of the Cue2Walk device in the own living environment + 8 weeks of naturalistic follow-up
Other: Control Group
Usual Care (+ Waiting List)
Other: Usual Care
24 weeks of receiving usual care + 8 weeks of using of the Cue2Walk device in the own living environment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
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)
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
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
Continuously from baseline (week 0) up to week 32

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
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
Weekly from baseline (week 0) up to week 32
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)
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
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
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Daily mobility
Time Frame: Continuously from baseline (week 0) up to week 32
Daily mobility will be determined by the Cue2Walk step count
Continuously from baseline (week 0) up to week 32
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)
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
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)
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
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)
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
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)
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
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
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
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)
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
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)
Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (week 0), week 8, week 16, Post-intervention (week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Collaborators

Radboud University Medical Center

Investigators

  • Principal Investigator: Erwin EH van Wegen, Dr., Amsterdam UMC, location VUmc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL86310.018.24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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