At Home REhabilitation and Monitoring of People in poST-covid Condition Through ARc-inTellicare Platform (RESTART/RICOMINCIARE) (RICOMINCIARE)

July 19, 2022 updated by: Camlin Ltd

RIabilitazione di Pazienti COvid e Loro Monitoraggio IN Casa Con la pIattaforma ARc-IntEllicare - (RICOMINCIARE)

The RESTART/RICOMINCIARE study is a pilot single-center, not controlled prospective, pre-post intervention study aimed at verifying feasibility and safety of a device-supported home rehabilitation for people suffering from mild to moderate disabilities due to respiratory or neurological conditions, related to Covid-19 or frailty condition (i.e. Parkinson Disease).

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The RICOMINCIARE project aims at contributing to the Covid-19 pandemic emergency by promoting the health and recovery of people recovering from Covid-19 and supporting frail people, providing an innovative telemedicine solution for the continuity of rehabilitation, able to promote and monitor remote physical rehabilitation activities in the elderly in isolation and remission from Covid-19, while containing the risk of spreading the infection. Between the people suffering from Covid-19, 80% show symptoms and 32% need hospitalization. It is estimated that the most severe cases (about 20%) have functional sequelae that persist for more than 6 months after diagnosis. In consideration of the absence of a vaccine or specific therapy, social distancing represents the main tool for limiting the infection. The use of tele-medicine is recommended and useful for everyone to ensure continuity of care in terms of monitoring, prevention and treatment

Primary objectives: to test the feasibility of integrating the ARC-Intellicare solution into the care pathway for Covid-19 survivors or frail people in terms of:

(i) adherence to the home rehabilitation program (ii) safety of rehabilitation therapy Secondary objectives: to investigate the (iiI) usability and acceptability of the intervention; (iv) the process and resources required for the new care pathway. The rehabilitation will take place according to the Good Clinical Practice (GCP) and the available guidelines regarding rehabilitation protocols and clinical and functional assessment for chronic respiratory syndromes, Post-Covid-19 conditions and neurological diseases related disabilities. Therefore, participants will undergo pre-post intervention monitoring of the clinical and functional status in terms of independence in the activities of daily life, endurance, fatigue, emotional state, quality of life following GCP.

Study design. The RICOMINCIARE study will be a pilot single-center, not controlled prospective, pre-post intervention study aimed at verifying feasibility and safety of a device supported home rehabilitation for people suffering from mild to moderate disabilities due to respiratory or neurological conditions possibly related to Covid-19.

Population. 5-10 people will be enrolled in the study between subjects who consecutively refers themselves to the study participating clinical center (Università Politecnica delle Marche, Dipartimento di Medicina Sperimentale e Clinica, Ancona) for rehabilitation management of a post-COVID-19 condition or in frailty.

A) Post-Covid-19 people: at home post-COVID-19 volunteers (discharged from hospital at home or treated at home) who have recovered from SARS-COV-2 infection (healing = two 24-hour consecutive oropharyngeal tampons negative for SARS-COV-2) from at least 15 days B) Frail people who score 9-12 on the Edmonton Frail Scale (EFS) due to neurological lesions of the motor system (i.e. Parkinson's Disease) or respiratory syndrome (COPD, pulmonary fibrosis...). Individuals should have no signs of ongoing pneumonia.

Intervention. The two-month study involves the recruitment of at least 20 patients who will use ARC-Intellicare at home, to perform usability tests and a collection of useful data in order to optimize the system.

Subsequently, the same patients will each receive an ARC-Intellicare unit for home use, to be used independently for the next 30 days.

45 minutes 5 days / week for 4 weeks of personalized training will be carried out by the enrolled subjects: 4 weekly sessions will be unsupervised, while one will be supervised remotely by a therapist in telepresence, thanks to the integrated audio-video channel.

Primary Endpoints. The primary endpoints are an adherence rate of 80% (+/- 5%) and a rate of participants' attrition (expected dropouts) of no more than 15%. The reasons for dropout or interruptions and side effects (number and types of adverse events related to the use of ARC) will also be monitored

Secondary endpoints. Secondary endpoints are a System Usability Scale (SUS) score administered to participants and informal health care workers or health care workers> 70 (i.e., the solution has a good level of usability) and a patient satisfaction of at least 80% on average on visual analog scale

Assessment timing. The entry variables and the clinical-functional data, according to the GCP, are acquired at enrolment / baseline assessment (T0) or within 7 days from the start of home intervention and at the end of the 30 days of intervention (T1), when monitoring of the primary and secondary outcome measures on adherence, acceptability and safety will be completed.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ancona, Italy, 60126
        • Università Politecnica delle Marche

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

A) Post-Covid-19 people: at home post-COVID-19 volunteers who have recovered from SARS-COV-2 infection (healing = two 24-hour consecutive oropharyngeal tampons negative for SARS-COV-2) from at least 15 days B) Frail people who score 9-12 on the Edmonton Frail Scale (EFS) due to neurological lesions of the motor system (e.g., Parkinson's Disease) or respiratory syndrome (e.g., COPD, pulmonary fibrosis)

All subjects have to meet the following criteria:

  1. Men and women> 18 years,
  2. Moderate dyspnea in activities of daily living (ADL) (Barthel's dyspnea score ≤55) or walking difficulties or upper limb disabilities due to central or peripheral neurological lesions that, eventually, emerged following Covid-19 or Walking Handicap Scale (Perry and Garrett '95) ≤ 5
  3. Informed consent signed

Exclusion Criteria:

  1. Fever (TC ≥ 37 ° C)
  2. Cough, cold, sore throat, diarrhoea or pneumonia signs and diagnosis
  3. People with moderate to severe cognitive impairment (MoCA <20)
  4. Formal rehabilitation performed in the last month
  5. Pre-existing disability related to neurodegenerative disorders or severe stroke (TACI); epilepsy, seizures and a history of severe dizziness and falls.
  6. Severe non-stabilized comorbidities: oncological diseases in the active phase; NYHA stage IV congestive heart failure; severe respiratory failure requiring cough and support for breathing; life expectancy of less than 6 months.
  7. Moderate or severe dependence in activities of daily living for any medical reason (such as the participant's inability to notice or suspect to comply with the protocol procedure) or other reason the investigator believes the participant is ineligible to study (Rankin mod. ≤ 8. Women of childbearing potential who are not using suitable valid methods of contraception

9. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARC intellicare

Study participants will use ARC intellicare at home, to carry out usability tests and a collection of useful data in order to optimise the system. After enrolment and training session, patients will receive an ARC unit to be used autonomously for the following 30 days.

45 minutes 5 days / week for 4 weeks of personalized training will be carried out by the enrolled subjects: 4 weekly sessions will be unsupervised, while one will be supervised remotely by a therapist in telepresence, thanks to the integrated audio-video channel.

ARC is a system that allows home motor and respiratory rehabilitation. The system includes 5 inertial measurement units for limbs and neck, a tablet with a dedicated app installed, to acquire and monitor the exercises performed by the patient in his/her daily rehab activity. Sensors and tablet can be charged on the base station. ARC allows the therapist to tailor the individual rehab project, with the support of a monitoring dashboard. The artificial intelligence engine analyses data coming from sensors positioned on the limbs, providing real-time feedback to the patient on the correct number of repetitions performed for each exercise. ARC allows therapists to create new exercises and/or select exercises from the ARC library to customize treatment (including tutorials and tips) based on condition-specific validated protocols and best practice. Patients can safely perform home rehabilitation sessions by wearing sensors and following video tutorials and tips from the ARC library.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence Rate
Time Frame: Daily evaluation performed on each patient using ARC during 30-day study period
Adherence to home rehabilitation program with ARC intellicare. The adherence rate is calculated as a percentage of the number of sessions performed at home by the patient compared to the maximum number of rehabilitation sessions prescribed with ARC.
Daily evaluation performed on each patient using ARC during 30-day study period
Device-related adverse events
Time Frame: Through study completion (8 months)
Number and type of device-related adverse events reported
Through study completion (8 months)
Attrition rate
Time Frame: Through study completion (8 months)
% of patients who discontinue the study before the 30-day intervention period
Through study completion (8 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale (SUS)
Time Frame: Pre (baseline) and post-intervention (30 days after)
The System Usability Scale (SUS) provides a reliable tool for measuring the usability of a device. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
Pre (baseline) and post-intervention (30 days after)
Patient Satisfaction
Time Frame: Pre (baseline) and post-intervention (30 days after)
Visual Analogue Scale (VAS) to assess patient's satisfaction in the use of ARC
Pre (baseline) and post-intervention (30 days after)
Resource consumption
Time Frame: Through study completion (8 months)
Quantification of the time allocated by each healthcare professional involved in the study, from patient training on the use of ARC until the end of the study, including intermediate visits and telephonic/remote support.
Through study completion (8 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Maria G Ceravolo, Prof., Università Politecnica delle Marche, Ancona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2021

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

October 11, 2021

First Posted (Actual)

October 12, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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