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OpenTrials
Completed

NCT Number: NCT06032468

ARC Intellicare for Telerehabilitation

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).

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Key information

Conditions

Parkinson Disease Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Movement Disorders Multiple Sclerosis Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Stroke Synucleinopathies Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

policlinico Universitario A Gemelli

Roma, Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARC Intellicare

Device

wearable devices to guide rehabilitation exercise

Rehabilitation sheets

Other

rehabilitation exercise sheets to guide rehabilitation exercise

Primary outcomes

  1. Efficacy outcome: Six minutes walking test (6MWT)

    Time frame: 8 weeks

    number of meters walked in brisk 6 minutes walk

  2. 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)

  3. safety outcome: adverse event frequency

    Time frame: 8 weeks

    number of adverse events reported

  4. Usability outcome: adherence to prescription

    Time frame: 8 weeks

    percent of rehabilitation sessions completed

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

ARC Intellicare for Telerehabilitation in Neurological Patients

Acronym: ARCTRAN

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2023
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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