ARC Intellicare for Telerehabilitation

NCT ID: NCT06032468

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2023-12-31

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).

Conditions

Parkinson Disease; Multiple Sclerosis; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rehabilitation with ARC Intellicare Device

rehabilitation exercise for 8 weeks using wearable devices

Group Type: EXPERIMENTAL

ARC Intellicare

Intervention Type: DEVICE

wearable devices to guide rehabilitation exercise

Rehabilitation with exercise sheet

rehabilitation exercise for 8 weeks using rehabilitation exercise sheets

Group Type: ACTIVE_COMPARATOR

Rehabilitation sheets

Intervention Type: OTHER

rehabilitation exercise sheets to guide rehabilitation exercise

Interventions

ARC Intellicare

wearable devices to guide rehabilitation exercise

Intervention Type: DEVICE

Rehabilitation sheets

rehabilitation exercise sheets to guide rehabilitation exercise

Intervention Type: OTHER

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
• dementia
• epilepsy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

policlinico Universitario A Gemelli

Roma, Rome, Italy

Countries

Italy

Other Identifiers

5135

Identifier Type: -

Identifier Source: org_study_id