NCT06032468

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 13, 2024

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

May 12, 2023

Last Update Submit

March 12, 2024

Conditions

Parkinson DiseaseMultiple SclerosisStroke

Outcome Measures

Primary Outcomes (4)

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

    number of meters walked in brisk 6 minutes walk

    8 weeks

  • Efficacy outcome: Borg scale

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

    8 weeks

  • safety outcome: adverse event frequency

    number of adverse events reported

    8 weeks

  • Usability outcome: adherence to prescription

    percent of rehabilitation sessions completed

    8 weeks

Study Arms (2)

Rehabilitation with ARC Intellicare Device

EXPERIMENTAL

rehabilitation exercise for 8 weeks using wearable devices

Device: ARC Intellicare

Rehabilitation with exercise sheet

ACTIVE COMPARATOR

rehabilitation exercise for 8 weeks using rehabilitation exercise sheets

Other: Rehabilitation sheets

Interventions

ARC IntellicareDEVICE

wearable devices to guide rehabilitation exercise

Rehabilitation with ARC Intellicare Device
Rehabilitation sheetsOTHER

rehabilitation exercise sheets to guide rehabilitation exercise

Rehabilitation with exercise sheet

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • history of falls
  • dementia
  • epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

policlinico Universitario A Gemelli

Roma, Rome, 00168, Italy

Location

MeSH Terms

Conditions

Parkinson DiseaseMultiple SclerosisStroke

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Early feasibility study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2023

First Posted

September 13, 2023

Study Start

January 9, 2023

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

March 13, 2024

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)