ARC Intellicare for Telerehabilitation (ARCTRAN)
Primary Purpose
Parkinson Disease, Multiple Sclerosis, Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ARC Intellicare
Rehabilitation sheets
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
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 dementia epilepsy
Sites / Locations
- policlinico Universitario A GemelliRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rehabilitation with ARC Intellicare Device
Rehabilitation with exercise sheet
Arm Description
rehabilitation exercise for 8 weeks using wearable devices
rehabilitation exercise for 8 weeks using rehabilitation exercise sheets
Outcomes
Primary Outcome Measures
Efficacy outcome: Six minutes walking test (6MWT)
number of meters walked in brisk 6 minutes walk
Efficacy outcome: Borg scale
score 0-20 of perceived effort during a motor task (higher scores mean a better or worse outcome)
safety outcome: adverse event frequency
number of adverse events reported
Usability outcome: adherence to prescription
percent of rehabilitation sessions completed
Secondary Outcome Measures
Full Information
NCT ID
NCT06032468
First Posted
May 12, 2023
Last Updated
September 4, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT06032468
Brief Title
ARC Intellicare for Telerehabilitation
Acronym
ARCTRAN
Official Title
ARC Intellicare for Telerehabilitation in Neurological Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Multiple Sclerosis, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Early feasibility study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation with ARC Intellicare Device
Arm Type
Experimental
Arm Description
rehabilitation exercise for 8 weeks using wearable devices
Arm Title
Rehabilitation with exercise sheet
Arm Type
Active Comparator
Arm Description
rehabilitation exercise for 8 weeks using rehabilitation exercise sheets
Intervention Type
Device
Intervention Name(s)
ARC Intellicare
Intervention Description
wearable devices to guide rehabilitation exercise
Intervention Type
Other
Intervention Name(s)
Rehabilitation sheets
Intervention Description
rehabilitation exercise sheets to guide rehabilitation exercise
Primary Outcome Measure Information:
Title
Efficacy outcome: Six minutes walking test (6MWT)
Description
number of meters walked in brisk 6 minutes walk
Time Frame
8 weeks
Title
Efficacy outcome: Borg scale
Description
score 0-20 of perceived effort during a motor task (higher scores mean a better or worse outcome)
Time Frame
8 weeks
Title
safety outcome: adverse event frequency
Description
number of adverse events reported
Time Frame
8 weeks
Title
Usability outcome: adherence to prescription
Description
percent of rehabilitation sessions completed
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
dementia
epilepsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flavia Torlizzi
Phone
0630155633
Email
flavia.torlizzi@policlinicogemelli.it
Facility Information:
Facility Name
policlinico Universitario A Gemelli
City
Roma
State/Province
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavia Torlizzi
Phone
0630155633
Email
flavia.torlizzi@policlinicogemelli.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ARC Intellicare for Telerehabilitation
We'll reach out to this number within 24 hrs