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临床试验/NCT06032468
NCT06032468已完成不适用

ARC Intellicare for Telerehabilitation in Neurological Patients

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年1月9日最近更新:
适应症
干预措施

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

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

Experimental

rehabilitation exercise for 8 weeks using wearable devices

干预措施: ARC Intellicare (Device)

Rehabilitation with exercise sheet

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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