Parkinson's disease Parkinson's disease
Conditions
Interventions
The intervention is 24 weeks in duration. In the first week, the participants 
in Group 1 will be instructed on general therapy goals as well as on use and 
handling of the device, and how to adequately respond to the cueing signals 
that the device generates. The Cue2Walk only provides a cueing signal when needed, i.e., when freezing of gait has been detected. The participant immediately starts using the device and usage will be
a secure portal on the website for additional instruction or clarification. Technical support can be given remotely via the secure Cue2Walk Int. support portal. Usage of this e-health component will b
monitored. All other medical care will continue as usual.
Participants allocated to Group 2 will be placed on a waiting list for 24 
weeks, during which they will receive usual care.
After these 24 weeks, an 8-week follow-up will be implemented for participants in Group 1, while participants in Group 2 will receive the same 
intervention as Group 1, but for 8 weeks.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Diagnosis of Parkinson's disease according to UK Brain bank criteriaDaily Freezing of GaitHoehn-Yahr stage 2-4Stable medication regime and/or DBS settings as determined by the treating neurologist for at least 4 weeks prior to screening or randomisationAbility to walk unassisted by another person
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical study 2. Use of a personal cueing device at home 3. Previous use of the Cue2Walk medical device 4. Presence of co-morbidities that would hamper participation 5. Cognitive impairment preventing understanding of therapeutic instructions (MoCa Score <16) Contraindications for the use of the device: 1. An allergy to one of the materials that the device or strap is made of 2. A significantly abnormal gait pattern 3. Absence of sensitivity to both cueing signals (auditory and vibro-tactile)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome to measure the effects of the intervention will be the disease-specific self-reported Quality of Life (Parkinson*s Disease Questionnaire, PDQ-39). The economic evaluation will be performed for general health-related quality of life (EuroQol 5 Dimensions 5 Level Survey; EQ-5D-5L) and Quality Adjusted Life Year (QALY). It will include a cost-effectiveness analysis and a Budget Impact Analysis. The cost-effectiveness as compared to usual care will be assessed from both a healthcare and a societal perspective. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be Time in Freezing of Gait (i.e. frequency and duration of FoG episodes; measured by the Cue2Walk device), Falls Efficacy (balance confidence, Falls EfficacyScale), numbers of falls (measured by weekly diary), Freezing of Gait severity (measured by the New Freezing of Gait Questionnaire and the Patient Reported Outcomes for Freezing of Gait), independence in ADL (Nottingham Extended ADL index), daily mobility (Cue2Walk step count score), mood (Hospital Anxiety and Depression Scale), Gait-Specific Attentional Profile, Acceptance of Illness (Chronic Illness Acceptance Questionnaire), Caregiver Burden (Zarit's Burden Interview Short Form). We will also use patient reported experience measures to quantify Patient Experiences regarding the intervention they receive during the intervention phase and we will record user experiences. | — |
Countries
Netherlands
Contacts
Public ContactE.E.H. van Wegen
Amsterdam UMC
Outcome results
None listed