ARCTRAN: ARC Intellicare for Telerehabilitation

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting ID

Study Details

Study Description

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, Identifier: NCT03787433) and RICOMINCIARE study (post-COVID19 and Parkinson's disease, Identifier: NCT05074771).

Condition or Disease Intervention/Treatment Phase
  • Device: ARC Intellicare
  • Other: Rehabilitation sheets

Study Design

Study Type:
Anticipated Enrollment :
90 participants
Intervention Model:
Parallel Assignment
Intervention Model Description:
Early feasibility studyEarly feasibility study
None (Open Label)
Primary Purpose:
Official Title:
ARC Intellicare for Telerehabilitation in Neurological Patients
Actual Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rehabilitation with ARC Intellicare Device

rehabilitation exercise for 8 weeks using wearable devices

Device: ARC Intellicare
wearable devices to guide rehabilitation exercise

Active Comparator: Rehabilitation with exercise sheet

rehabilitation exercise for 8 weeks using rehabilitation exercise sheets

Other: Rehabilitation sheets
rehabilitation exercise sheets to guide rehabilitation exercise

Outcome Measures

Primary Outcome Measures

  1. Efficacy outcome: Six minutes walking test (6MWT) [8 weeks]

    number of meters walked in brisk 6 minutes walk

  2. Efficacy outcome: Borg scale [8 weeks]

    score 0-20 of perceived effort during a motor task (higher scores mean a better or worse outcome)

  3. safety outcome: adverse event frequency [8 weeks]

    number of adverse events reported

  4. Usability outcome: adherence to prescription [8 weeks]

    percent of rehabilitation sessions completed

Eligibility Criteria


Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Accepts 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

Contacts and Locations


Site City State Country Postal Code
1 policlinico Universitario A Gemelli Roma Rome Italy 00168

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Identifier:
Other Study ID Numbers:
  • 5135
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2023