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| Name | Class |
|---|---|
| Radboud University Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | At-home use of the Cue2Walk |
|
| Control Group | Other | Usual Care (+ Waiting List) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cue2Walk | Device | 24 weeks of using of the Cue2Walk device in the own living environment + 8 weeks of naturalistic follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Numbers of falls |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erwin EH van Wegen, PhD | Contact | 020-4440461 | e.vanwegen@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Erwin EH van Wegen, PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Not yet recruiting | Nijmegen | Gelderland | 6525 GA | Netherlands |
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| Usual Care | Other | 24 weeks of receiving usual care + 8 weeks of using of the Cue2Walk device in the own living environment |
|
The number of falls and near-falls will be determined with a weekly diary
| 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) | 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) | 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) | 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 | 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 | Continuously from baseline (week 0) up to week 32 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Amsterdam UMC, location VUmc | Recruiting | Amsterdam | North Holland | 1081HZ | Netherlands |
|
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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