## Protocol Section
### Identification Module
**NCT ID:** NCT06416345

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

**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

#### Organization Study ID Info
**ID:** NL86310.018.24
#### Organization
**Class:** OTHER
**Full Name:** Amsterdam UMC, location VUmc
### Status Module
#### Completion Date
**Date:** 2027-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Radboud University Medical Center

#### Lead Sponsor

**Class:** OTHER

**Name:** Amsterdam UMC, location VUmc

#### Responsible Party

**Investigator Affiliation:** Amsterdam UMC, location VUmc

**Investigator Full Name:** Dr. Erwin E. H. van Wegen

**Investigator Title:** Principal Investigator, Associate Professor Neurorehabilitation

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Parkinson Disease

**Keywords:**

- Parkinson's Disease

- Freezing of Gait

- (Smart) Cueing

- Costeffectiveness

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 84

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** At-home use of the Cue2Walk

**Intervention Names:**

- Device: Cue2Walk

**Label:** Intervention Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Usual Care (+ Waiting List)

**Intervention Names:**

- Other: Usual Care

**Label:** Control Group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention Group

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

**Name:** Cue2Walk

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Control Group

**Description:** 24 weeks of receiving usual care + 8 weeks of using of the Cue2Walk device in the own living environment

**Name:** Usual Care

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** For the economic evaluation, resource utilization will be determined by a cost questionnaire

**Measure:** Resource Utilization

**Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24)

#### Primary Outcomes

**Description:** Self-reported quality of life will be determined using the Parkinson's Disease Questionnaire (PDQ-39)

**Measure:** Self-reported quality of life

**Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

**Description:** General health-related quality of life will be determined using the EuroQol 5 Dimensions 5 Level Survey (EQ-5D-5L)

**Measure:** General health-related quality of life

**Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

**Description:** Time in Freezing of Gait (i.e. frequency and duration of FoG) will be determined by the Cue2Walk medical device

**Measure:** Time in Freezing of Gait

**Time Frame:** Continuously from baseline (week 0) up to week 32

#### Secondary Outcomes

**Description:** The level of concern about falling during various activities will be determined by the Falls Efficacy Scale International (FES-I)

**Measure:** Falls Efficacy

**Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

**Description:** The number of falls and near-falls will be determined with a weekly diary

**Measure:** Numbers of falls

**Time Frame:** Weekly from baseline (week 0) up to week 32

**Description:** Freezing of Gait severity will be determined by the New Freezing of Gait Questionnaire (NFOG-Q)

**Measure:** Freezing of Gait severity

**Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

**Description:** Freezing of Gait severity will be determined by the Patient Reported Outcomes for Freezing of Gait (PRO-FOG)

**Measure:** Freezing of Gait severity

**Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

**Description:** Independence in Activities of Daily Living will be determined by the Nottingham Extended Activities of Daily Living Index (NEADL)

**Measure:** Independence in Activities of Daily Living

**Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

**Description:** Motor Aspects of Experiences of Daily Living will be determined by MDS-UPDRS part II

**Measure:** Motor Aspects of Experiences of Daily Living

**Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

**Description:** Daily mobility will be determined by the Cue2Walk step count

**Measure:** Daily mobility

**Time Frame:** Continuously from baseline (week 0) up to week 32

**Description:** Mood will be determined by Hospital Anxiety and Depression Scale (HADS)

**Measure:** Mood

**Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

**Description:** Gait-Specific Attentional Profile will be determined by the Gait-Specific Attentional Profile questionnaire (G-SAP)

**Measure:** Gait-Specific Attentional Profile

**Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

**Description:** Acceptance of illness will be determined by the Chronic Illness Acceptance Questionnaire (CIAQ)

**Measure:** Acceptance of Illness

**Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

**Description:** Caregiver burden will be determined by Zarit's Burden Interview Short Form (ZBI-12)

**Measure:** Caregiver burden

**Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

**Description:** 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

**Measure:** Patient experiences

**Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32

### Eligibility Module

**Eligibility Criteria:** 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)

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** e.vanwegen@amsterdamumc.nl

**Name:** Erwin EH van Wegen, Dr.

**Phone:** 020-4440461

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Amsterdam

**Contacts:**

***Contact 1:***

- **Email:** e.vanwegen@amsterdamumc.nl

- **Name:** Erwin EH van Wegen, Dr.

- **Phone:** 020-4440461

- **Role:** CONTACT

***Contact 2:***

- **Name:** Erwin EH van Wegen, Dr.

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Matthijs van der Laan, MSc

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Marc B. Rietberg, Dr.

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Jorik H. Nonnekes, Dr.

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Vincent de Groot, Prof. dr.

- **Role:** SUB_INVESTIGATOR

**Country:** Netherlands

**Facility:** Amsterdam UMC, location VUmc

**State:** Noord-Holland

**Zip:** 1081HZ

#### Overall Officials

**Official 1:**

**Affiliation:** Amsterdam UMC, location VUmc

**Name:** Erwin EH van Wegen, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020734

- Term: Parkinsonian Disorders

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000080874

- Term: Synucleinopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M22494

- Name: Parkinsonian Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2217

- Name: Synucleinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010300

- Term: Parkinson Disease

### Misc Info Module

- Version Holder: 2024-05-31
