At Home REhabilitation and Monitoring of People in poST-covid Condition Through ARc-inTellicare Platform (RESTART/RICOMINCIARE)
Condition: Post-COVID19; Parkinson Disease
MeSH terms: COVID-19; Parkinson Disease
Study type: Interventional

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).
    

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.
    

Intervention name(s): ARC intellicare
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: COVID19 Parkinson Home Rehabilitation