ARC Intellicare for Telerehabilitation

Stroke Clinical Trial

— ARCTRAN  

Official title:

ARC Intellicare for Telerehabilitation in Neurological Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06032468
• Other study ID #: 5135
• Status: Completed
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Parkinson Disease
• Stroke

Intervention

Device:
• ARC Intellicare
wearable devices to guide rehabilitation exercise

Other:
• Rehabilitation sheets
rehabilitation exercise sheets to guide rehabilitation exercise

Locations

Country	Name	City	State
Italy	policlinico Universitario A Gemelli	Roma	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

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