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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
84
24 weeks of using of the Cue2Walk device in the own living environment + 8 weeks of naturalistic follow-up
24 weeks of receiving usual care + 8 weeks of using of the Cue2Walk device in the own living environment
Amsterdam UMC, location VUmc
Amsterdam, North Holland, Netherlands
Self-reported quality of life
Self-reported quality of life will be determined using the Parkinson's Disease Questionnaire (PDQ-39)
Time frame: 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)
Time frame: 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
Time frame: Continuously from baseline (week 0) up to week 32
Falls Efficacy
The level of concern about falling during various activities will be determined by the Falls Efficacy Scale International (FES-I)
Time frame: 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
Time frame: 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)
Time frame: 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)
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Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Continuously from baseline (week 0) up to week 32
Mood
Mood will be determined by Hospital Anxiety and Depression Scale (HADS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32