ARC Intellicare for Telerehabilitation

Study Overview
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Brief Summary
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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).

Official Title
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ARC Intellicare for Telerehabilitation in Neurological Patients

Conditions
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Stroke, Parkinson Disease, Multiple Sclerosis

Intervention / Treatment
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* Device: ARC Intellicare
* Other: Rehabilitation sheets


Participation Criteria
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Eligibility Criteria
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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 dementia epilepsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Early feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation with ARC Intellicare Device<br>rehabilitation exercise for 8 weeks using wearable devices | Device: ARC Intellicare<br>* wearable devices to guide rehabilitation exercise<br>|
| Active Comparator: Rehabilitation with exercise sheet<br>rehabilitation exercise for 8 weeks using rehabilitation exercise sheets | Other: Rehabilitation sheets<br>* rehabilitation exercise sheets to guide rehabilitation exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy outcome: Six minutes walking test (6MWT) | number of meters walked in brisk 6 minutes walk | 8 weeks | 
| Efficacy outcome: Borg scale | score 0-20 of perceived effort during a motor task (higher scores mean a better or worse outcome) | 8 weeks | 
| safety outcome: adverse event frequency | number of adverse events reported | 8 weeks | 
| Usability outcome: adherence to prescription | percent of rehabilitation sessions completed | 8 weeks |