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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416345
• Other study ID #: NL86310.018.24
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: September 1, 2027

Study information

• Verified date: May 2024
• Source: Amsterdam UMC, location VUmc
• Contact: Erwin EH van Wegen, Dr.
• Phone: 020-4440461
• Email: e.vanwegen[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Cue2Walk
24 weeks of using of the Cue2Walk device in the own living environment + 8 weeks of naturalistic follow-up

Other:
• Usual Care
24 weeks of receiving usual care + 8 weeks of using of the Cue2Walk device in the own living environment

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location VUmc	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc	Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resource Utilization	For the economic evaluation, resource utilization will be determined by a cost questionnaire	Baseline (week 0), week 8, week 16, Post-intervention (week 24)
Primary	Self-reported quality of life	Self-reported quality of life will be determined using the Parkinson's Disease Questionnaire (PDQ-39)	Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Primary	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)	Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Primary	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	Continuously from baseline (week 0) up to week 32
Secondary	Falls Efficacy	The level of concern about falling during various activities will be determined by the Falls Efficacy Scale International (FES-I)	Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Secondary	Numbers of falls	The number of falls and near-falls will be determined with a weekly diary	Weekly from baseline (week 0) up to week 32
Secondary	Freezing of Gait severity	Freezing of Gait severity will be determined by the New Freezing of Gait Questionnaire (NFOG-Q)	Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Secondary	Freezing of Gait severity	Freezing of Gait severity will be determined by the Patient Reported Outcomes for Freezing of Gait (PRO-FOG)	Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Secondary	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)	Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Secondary	Motor Aspects of Experiences of Daily Living	Motor Aspects of Experiences of Daily Living will be determined by MDS-UPDRS part II	Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Secondary	Daily mobility	Daily mobility will be determined by the Cue2Walk step count	Continuously from baseline (week 0) up to week 32
Secondary	Mood	Mood will be determined by Hospital Anxiety and Depression Scale (HADS)	Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Secondary	Gait-Specific Attentional Profile	Gait-Specific Attentional Profile will be determined by the Gait-Specific Attentional Profile questionnaire (G-SAP)	Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Secondary	Acceptance of Illness	Acceptance of illness will be determined by the Chronic Illness Acceptance Questionnaire (CIAQ)	Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Secondary	Caregiver burden	Caregiver burden will be determined by Zarit's Burden Interview Short Form (ZBI-12)	Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32
Secondary	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	Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32