ARC Intellicare for Telerehabilitation

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Stroke; Parkinson Disease
• Interventions: Device: ARC Intellicare; Other: Rehabilitation sheets

• Registration Number: NCT06032468
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-09
• Status Verified: 2023-05
• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-09-04
• Study First Posted: 2023-09-13
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitation with ARC Intellicare Device	ARC Intellicare	rehabilitation exercise for 8 weeks using wearable devices
Rehabilitation with exercise sheet	Rehabilitation sheets	rehabilitation exercise for 8 weeks using rehabilitation exercise sheets

Primary Outcome Measures

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

Trial Locations

Locations (1)

policlinico Universitario A Gemelli; 🇮🇹 Roma, Rome, Italy