ARCTRAN: ARC Intellicare for Telerehabilitation

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06032468
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.7
• Patients Per Site Per Month: 7.7

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease; Multiple Sclerosis; Stroke	Device: ARC Intellicare; Other: Rehabilitation sheets	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Early feasibility studyEarly feasibility study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ARC Intellicare for Telerehabilitation in Neurological Patients
• Actual Study Start Date: Jan 9, 2023
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rehabilitation with ARC Intellicare Device rehabilitation exercise for 8 weeks using wearable devices	Device: ARC Intellicare; wearable devices to guide rehabilitation exercise
Active Comparator: Rehabilitation with exercise sheet rehabilitation exercise for 8 weeks using rehabilitation exercise sheets	Other: Rehabilitation sheets; rehabilitation exercise sheets to guide rehabilitation exercise

Outcome Measures

Primary Outcome Measures

1. Efficacy outcome: Six minutes walking test (6MWT) [8 weeks]

   number of meters walked in brisk 6 minutes walk

2. Efficacy outcome: Borg scale [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 [8 weeks]

   number of adverse events reported

4. Usability outcome: adherence to prescription [8 weeks]

   percent of rehabilitation sessions completed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: 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:

• history of falls

• dementia

• epilepsy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	policlinico Universitario A Gemelli	Roma	Rome	Italy	00168

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT06032468
• Other Study ID Numbers: 5135
• First Posted: Sep 13, 2023
• Last Update Posted: Sep 13, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinson Disease; Multiple Sclerosis

Study Results

No Results Posted as of Sep 13, 2023