Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Self-reported quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Intervention Group
At-home use of the Cue2Walk
干预措施: Cue2Walk (Device)
Control Group
Usual Care (+ Waiting List)
干预措施: Usual Care (Other)
结局指标
主要结局
Self-reported quality of life
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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)
研究者
Dr. Erwin E. H. van Wegen
Principal Investigator, Associate Professor Neurorehabilitation
Amsterdam UMC, location VUmc