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Clinical Trials/NCT06032468
NCT06032468
Completed
Not Applicable

ARC Intellicare for Telerehabilitation in Neurological Patients

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country90 target enrollmentJanuary 9, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
90
Locations
1
Primary Endpoint
Usability outcome: adherence to prescription
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 9, 2023
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Usability outcome: adherence to prescription

Time Frame: 8 weeks

percent of rehabilitation sessions completed

safety outcome: adverse event frequency

Time Frame: 8 weeks

number of adverse events reported

Efficacy outcome: Six minutes walking test (6MWT)

Time Frame: 8 weeks

number of meters walked in brisk 6 minutes walk

Efficacy outcome: Borg scale

Time Frame: 8 weeks

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

Study Sites (1)

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