ARC Intellicare for Telerehabilitation (ARCTRAN)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Stroke; Multiple Sclerosis; Parkinson Disease

Treatments: Device: ARC Intellicare; Other: Rehabilitation sheets

Study type: Interventional

Funder types: Other

Identifiers

NCT06032468

5135

Details and patient eligibility

About

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).

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Rehabilitation with ARC Intellicare Device

Experimental group

Description:

rehabilitation exercise for 8 weeks using wearable devices

Treatment:

Device: ARC Intellicare

Rehabilitation with exercise sheet

Active Comparator group

Description:

rehabilitation exercise for 8 weeks using rehabilitation exercise sheets

Treatment:

Other: Rehabilitation sheets