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

Parkinson Disease Clinical Trial

— RICOMINCIARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05074771
• Other study ID #: RICOMINCIARE
• Status: Completed
• Phase: N/A
• Start date: March 26, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: July 2022
• Source: Camlin Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Parkinson Disease
• Post-COVID19

Intervention

Device:
• ARC intellicare
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.

Locations

Country	Name	City	State
Italy	Università Politecnica delle Marche	Ancona

Sponsors (2)

Lead Sponsor	Collaborator
Camlin Ltd	Università Politecnica delle Marche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence Rate	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
Primary	Device-related adverse events	Number and type of device-related adverse events reported	Through study completion (8 months)
Primary	Attrition rate	% of patients who discontinue the study before the 30-day intervention period	Through study completion (8 months)
Secondary	System Usability Scale (SUS)	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)
Secondary	Patient Satisfaction	Visual Analogue Scale (VAS) to assess patient's satisfaction in the use of ARC	Pre (baseline) and post-intervention (30 days after)
Secondary	Resource consumption	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)