ARC Intellicare for Telerehabilitation in Neurological Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Usability outcome: adherence to prescription
研究概览
简要总结
In the last 5 years, the available literature evidence has indicated that, in terms of clinical efficacy, telerehabilitation can give comparable results compared to face-to-face rehabilitation. Studies of post-stroke patients have revealed some benefits of telerehabilitation, such as the ability for patients to self-record pain, mood and activity. Telerehabilitation has comparable efficacy to face-to-face rehabilitation for the recovery of some abilities, such as motor function, Activities of Daily Living (ADL), and independence; it is less effective, however, for the recovery of balance control. Published reviews concerning, in particular, neurological/neurodegenerative diseases show that telerehabilitation systems are effective in maintaining and/or improving some motor aspects, such as balance and gait, and non-motor aspects, such as mood and quality of life; they also increase patient satisfaction, so in the long term they appear to be beneficial, convenient and satisfying for patients and operators.
ARC Intellicare is a device undergoing certification as a Class I Medical Device (DM), already clinically tested during two uncontrolled clinical feasibility studies: ARCANGEL study (post-stroke, ClinicalTrials.gov Identifier: NCT03787433) and RICOMINCIARE study (post-COVID19 and Parkinson's disease, ClinicalTrials.gov Identifier: NCT05074771).
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with diagnosis of Parkinson's disease with Hoehn&Yahr staging 1-3
- •diagnosis of multiple sclerosis with extended disability scale score 3.5-6
- •diagnosis of ischemic stroke in the past 12 months
排除标准
- •history of falls
研究组 & 干预措施
Rehabilitation with ARC Intellicare Device
rehabilitation exercise for 8 weeks using wearable devices
干预措施: ARC Intellicare (Device)
Rehabilitation with exercise sheet
rehabilitation exercise for 8 weeks using rehabilitation exercise sheets
干预措施: Rehabilitation sheets (Other)
结局指标
主要结局
Usability outcome: adherence to prescription
时间窗: 8 weeks
percent of rehabilitation sessions completed
safety outcome: adverse event frequency
时间窗: 8 weeks
number of adverse events reported
Efficacy outcome: Six minutes walking test (6MWT)
时间窗: 8 weeks
number of meters walked in brisk 6 minutes walk
Efficacy outcome: Borg scale
时间窗: 8 weeks
score 0-20 of perceived effort during a motor task (higher scores mean a better or worse outcome)
次要结局
未报告次要终点
