Parkinson DiseaseNCT06416345
Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease
A study testing Cue2Walk in people with Parkinson Disease, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Cue2Walk
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesNetherlands
- Study dates
- 22 Aug 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC, location VUmc
Amsterdam, North Holland, 1081HZ
Erwin EH van Wegen, Dr., 020-4440461, e.vanwegen@amsterdamumc.nl
Erwin EH van Wegen, PhD
- Not yet recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA
Jorik Nonnekes, MD, PhD, Jorik.Nonnekes@radboudumc.nl
Jorik Nonnekes, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Cue2Walk, Usual Care
- Keywords
- Parkinson's Disease, Freezing of Gait, (Smart) Cueing, Costeffectiveness
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cue2WalkDevice
24 weeks of using of the Cue2Walk device in the own living environment + 8 weeks of naturalistic follow-up
Usual CareOther
24 weeks of receiving usual care + 8 weeks of using of the Cue2Walk device in the own living environment
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | At-home use of the Cue2Walk Receives: Device: Cue2Walk |
| Control Group | Other | Usual Care (+ Waiting List) Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported quality of life
Self-reported quality of life will be determined using the Parkinson's Disease Questionnaire (PDQ-39)
Measured: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
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)
Measured: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
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
Measured: Continuously from baseline (week 0) up to week 32
Secondary outcomes (12)
Falls Efficacy
The level of concern about falling during various activities will be determined by the Falls Efficacy Scale International (FES-I)
Measured: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Numbers of falls
The number of falls and near-falls will be determined with a weekly diary
Measured: Weekly from baseline (week 0) up to week 32
Freezing of Gait severity
Freezing of Gait severity will be determined by the New Freezing of Gait Questionnaire (NFOG-Q)
Measured: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Freezing of Gait severity
Freezing of Gait severity will be determined by the Patient Reported Outcomes for Freezing of Gait (PRO-FOG)
Measured: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Independence in Activities of Daily Living
Independence in Activities of Daily Living will be determined by the Nottingham Extended Activities of Daily Living Index (NEADL)
Measured: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Motor Aspects of Experiences of Daily Living
Motor Aspects of Experiences of Daily Living will be determined by MDS-UPDRS part II
Measured: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Daily mobility
Daily mobility will be determined by the Cue2Walk step count
Measured: Continuously from baseline (week 0) up to week 32
Mood
Mood will be determined by Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Gait-Specific Attentional Profile
Gait-Specific Attentional Profile will be determined by the Gait-Specific Attentional Profile questionnaire (G-SAP)
Measured: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Acceptance of Illness
Acceptance of illness will be determined by the Chronic Illness Acceptance Questionnaire (CIAQ)
Measured: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Caregiver burden
Caregiver burden will be determined by Zarit's Burden Interview Short Form (ZBI-12)
Measured: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Patient experiences
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
Measured: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start22 Aug 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Principal investigator, Dr. Erwin E. H. van Wegen, Amsterdam UMC, location VUmc
- Investigators
- Erwin EH van Wegen, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416345
- Sponsor's protocol ID
- NL86310.018.24
- Status last verified
- Mar 2026
- First submitted
- 7 May 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06416345
- Acronym / sponsor ID
- NL86310.018.24
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Freezing of Gait, (Smart) Cueing, Costeffectiveness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Cue2WalkAt-home use of the Cue2Walk |
| Control Group | Other | Other: Usual CareUsual Care (+ Waiting List) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cue2Walk24 weeks of using of the Cue2Walk device in the own living environment + 8 weeks of naturalistic follow-up | Device | Intervention Group |
| Usual Care24 weeks of receiving usual care + 8 weeks of using of the Cue2Walk device in the own living environment | Other | Control Group |
Primary outcome
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)
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)
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
12 secondary outcomes
Falls Efficacy
Time frame: 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
Freezing of Gait severity
Time frame: 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
Independence in Activities 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
Time frame: 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
Mood
Time frame: 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
Acceptance of Illness
Time frame: 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
Patient experiences
Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erwin EH van Wegen, PhD principal investigator
Amsterdam UMC, location VUmc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cue2Walk in people with Parkinson Disease, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erwin EH van Wegen, PhD (020-4440461, e.vanwegen@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported quality of life (time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.