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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05074771
Recruitment Status : Completed
First Posted : October 12, 2021
Last Update Posted : July 20, 2022
Sponsor:
Collaborator:
Università Politecnica delle Marche
Information provided by (Responsible Party):
Camlin Ltd

Brief 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).

Condition or disease Intervention/treatment Phase
Post-COVID19 Parkinson Disease Device: ARC intellicare Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: RIabilitazione di Pazienti COvid e Loro Monitoraggio IN Casa Con la pIattaforma ARc-IntEllicare - (RICOMINCIARE)
Actual Study Start Date : March 26, 2021
Actual Primary Completion Date : March 30, 2022
Actual Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. 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.

  2. Device-related adverse events [ Time Frame: Through study completion (8 months) ]
    Number and type of device-related adverse events reported

  3. Attrition rate [ Time Frame: Through study completion (8 months) ]
    % of patients who discontinue the study before the 30-day intervention period


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05074771


Locations
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Italy
Università Politecnica delle Marche
Ancona, Italy, 60126
Sponsors and Collaborators
Camlin Ltd
Università Politecnica delle Marche
Investigators
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Principal Investigator: Maria G Ceravolo, Prof. Università Politecnica delle Marche, Ancona
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Responsible Party: Camlin Ltd
ClinicalTrials.gov Identifier: NCT05074771    
Other Study ID Numbers: RICOMINCIARE
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Camlin Ltd:
COVID19 Parkinson Home Rehabilitation
Additional relevant MeSH terms:
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COVID-19
Parkinson Disease
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases