Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Cue2Walk, Usual Care.
- Кому может быть актуально
- Состояния в реестре: Parkinson Disease. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство Cue2Walk
24 weeks of using of the Cue2Walk device in the own living environment + 8 weeks of naturalistic follow-up - Другое Usual Care
24 weeks of receiving usual care + 8 weeks of using of the Cue2Walk device in the own living environment
Первичные конечные точки
- Self-reported quality of life [Срок оценки: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- General health-related quality of life [Срок оценки: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Time in Freezing of Gait [Срок оценки: Continuously from baseline (week 0) up to week 32]
Вторичные конечные точки (12)
- Falls Efficacy [Срок оценки: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Numbers of falls [Срок оценки: Weekly from baseline (week 0) up to week 32]
- Freezing of Gait severity [Срок оценки: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Freezing of Gait severity [Срок оценки: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Independence in Activities of Daily Living [Срок оценки: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Motor Aspects of Experiences of Daily Living [Срок оценки: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Daily mobility [Срок оценки: Continuously from baseline (week 0) up to week 32]
- Mood [Срок оценки: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Gait-Specific Attentional Profile [Срок оценки: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Acceptance of Illness [Срок оценки: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Caregiver burden [Срок оценки: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
- Patient experiences [Срок оценки: Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Нидерланды · 2 центра
- Radboudumc — Nijmegen
- Amsterdam UMC, location VUmc — Amsterdam
Идентификаторы
NCT: NCT06416345 · NL86310.018.24