Parkinson Disease
Conditions
Keywords
Parkinson's Disease, Freezing of Gait, (Smart) Cueing, Costeffectiveness
Brief 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. 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.
Interventions
DEVICECue2Walk
24 weeks of using of the Cue2Walk device in the own living environment + 8 weeks of naturalistic follow-up
OTHERUsual Care
24 weeks of receiving usual care + 8 weeks of using of the Cue2Walk device in the own living environment
Sponsors
Amsterdam UMC, location VUmc
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported quality of life | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of falls | Weekly from baseline (week 0) up to week 32 | The number of falls and near-falls will be determined with a weekly diary |
| Freezing of Gait severity | 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) |
| Independence in Activities of Daily Living | 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) |
| Mood | Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32 | Mood will be determined by Hospital Anxiety and Depression Scale (HADS) |
| Gait-Specific Attentional Profile | 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) |
| Acceptance of Illness | 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) |
| Caregiver burden | 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) |
| Daily mobility | Continuously from baseline (week 0) up to week 32 | Daily mobility will be determined by the Cue2Walk step count |
| Patient experiences | 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 |
| Motor Aspects of Experiences of Daily Living | 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 |
| Falls Efficacy | 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) |
Countries
Netherlands
Contacts
CONTACTErwin EH van Wegen, PhD
PRINCIPAL_INVESTIGATORErwin EH van Wegen, PhD
Amsterdam UMC, location VUmc
Outcome results
None listed