Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Self-reported quality of life
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts 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)
Arms & Interventions
Intervention Group
At-home use of the Cue2Walk
Intervention: Cue2Walk (Device)
Control Group
Usual Care (+ Waiting List)
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Motor Aspects of Experiences of Daily Living(Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32)
- Caregiver burden(Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32)
- Falls Efficacy(Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32)
- Numbers of falls(Weekly from baseline (week 0) up to week 32)
- Mood(Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32)
- Patient experiences(Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32)
- Independence in Activities of Daily Living(Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32)
- Daily mobility(Continuously from baseline (week 0) up to week 32)
- Gait-Specific Attentional Profile(Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32)
- Acceptance of Illness(Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32)
- Freezing of Gait severity(Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32)
Investigators
Dr. Erwin E. H. van Wegen
Principal Investigator, Associate Professor Neurorehabilitation
Amsterdam UMC, location VUmc