CClinicalTrials.gg
CompletedNCT06032468ARCTRANUpdated Mar 13, 2024

ARC Intellicare for Telerehabilitation

An interventional study of ARC Intellicare and Rehabilitation sheets in Parkinson Disease, Multiple Sclerosis and Stroke, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-13.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2023, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Parkinson Disease
  • Multiple Sclerosis
  • Stroke
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 90 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • history of falls
  • dementia
  • epilepsy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Rehabilitation with ARC Intellicare Device

    rehabilitation exercise for 8 weeks using wearable devices

    Device: ARC Intellicare

  • Active comparator
    Rehabilitation with exercise sheet

    rehabilitation exercise for 8 weeks using rehabilitation exercise sheets

    Other: Rehabilitation sheets

Interventions

  • DeviceARC Intellicare

    wearable devices to guide rehabilitation exercise

  • OtherRehabilitation sheets

    rehabilitation exercise sheets to guide rehabilitation exercise

06

What researchers measure

Primary outcomes

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

    number of meters walked in brisk 6 minutes walk

    Time frame: 8 weeks

  2. Efficacy outcome: Borg scale

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

    Time frame: 8 weeks

  3. safety outcome: adverse event frequency

    number of adverse events reported

    Time frame: 8 weeks

  4. Usability outcome: adherence to prescription

    percent of rehabilitation sessions completed

    Time frame: 8 weeks

07

Study locations

1 site
  • policlinico Universitario A Gemelli
    Roma, Rome 00168, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06032468
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
Sep 13, 2023
Start date
Jan 9, 2023
Primary completion
Sep 30, 2023
Completion
Dec 31, 2023
Last update
Mar 13, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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