ARC Intellicare for Telerehabilitation in Neurological Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Usability outcome: adherence to prescription
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •history of falls
Outcomes
Primary Outcomes
Usability outcome: adherence to prescription
Time Frame: 8 weeks
percent of rehabilitation sessions completed
safety outcome: adverse event frequency
Time Frame: 8 weeks
number of adverse events reported
Efficacy outcome: Six minutes walking test (6MWT)
Time Frame: 8 weeks
number of meters walked in brisk 6 minutes walk
Efficacy outcome: Borg scale
Time Frame: 8 weeks
score 0-20 of perceived effort during a motor task (higher scores mean a better or worse outcome)