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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
wearable devices to guide rehabilitation exercise
rehabilitation exercise sheets to guide rehabilitation exercise
policlinico Universitario A Gemelli
Roma, Rome, Italy
Efficacy outcome: Six minutes walking test (6MWT)
number of meters walked in brisk 6 minutes walk
Time frame: 8 weeks
Efficacy outcome: Borg scale
score 0-20 of perceived effort during a motor task (higher scores mean a better or worse outcome)
Time frame: 8 weeks
safety outcome: adverse event frequency
number of adverse events reported
Time frame: 8 weeks
Usability outcome: adherence to prescription
percent of rehabilitation sessions completed
Time frame: 8 weeks
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