ARC Intellicare for Telerehabilitation in Neurological Patients

CompletedNot a drug-phase studyMS (type not specified)NCT06032468

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • ARC Intellicare

Compared with

  • Rehabilitation sheets

What it measured

Main measures

  • Efficacy outcome: Six minutes walking test (6MWT)

    8 weeks

    Walking and mobility
  • Efficacy outcome: Borg scale

    8 weeks

  • safety outcome: adverse event frequency

    8 weeks

    Safety
  • Usability outcome: adherence to prescription

    8 weeks

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 75

Show the full 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 * dementia * epilepsy

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

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    History

      1. Started

        Jan 2023

      2. Main results due

        Sept 2023

      3. Finished

        Dec 2023

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