Recruiting · registry status

Testing automatic cues when walking freezes

Researchers compare a device that detects freezing and provides walking cues with usual care, including an assessment of costs.

Testing a treatment or activity · Study reference: NCT06416345

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Looking for volunteers

Start (reported actual date): 2025-08-22
Main measurements finished (planned): 2027-12-01
Study finished (planned): 2027-12-01

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded

2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Age range not listed · Does not accept healthy volunteers

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Read all the rules for taking part

Sex eligibility reported by registry: all

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)

Full study name & original research details

Official study title

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

Original description

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.

Further description from the registry

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 reported: Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

ClinicalTrials.gov · NCT06416345 ↗ — RECRUITING; checked 2026-10-11
NL-OMON · NL-OMON57004 ↗ — Recruiting; WHO ICTRP processed 2026-03-16; checked 2026-10-11

Study type: Interventional
Interventions: Cue2Walk; Usual Care
Phases: NA
Sponsor: Amsterdam UMC, location VUmc
Start date reported by registry: 2025-08-22 (actual)

Registry updated: 2026-03-16 · Status last verified by the registry submitter: 2026-03

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Erwin EH van Wegen, PhD · 020-4440461 · e.vanwegen@amsterdamumc.nl

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Radboudumc

Nijmegen, Gelderland, Netherlands

Not yet recruiting

Jorik Nonnekes, MD, PhD · Jorik.Nonnekes@radboudumc.nl

Jorik Nonnekes, MD, PhD

Lotte van de Venis, PhD

Amsterdam UMC, location VUmc

Amsterdam, North Holland, Netherlands

Recruiting

Erwin EH van Wegen, Dr. · 020-4440461 · e.vanwegen@amsterdamumc.nl

Erwin EH van Wegen, PhD

Matthijs van der Laan, MSc

Marc B. Rietberg, PhD

Vincent de Groot, Prof. dr.

Facility not reported

Netherlands

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.