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

NCT05074771 | Completed

• 1 other identifier: RICOMINCIARE
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Post-COVID19; Parkinson Disease

Keywords

COVID19 Parkinson Home Rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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

• Device-related adverse events

  Number and type of device-related adverse events reported

  Through study completion (8 months)

• Attrition rate

  % of patients who discontinue the study before the 30-day intervention period

  Through study completion (8 months)

Secondary Outcomes (3)

• System Usability Scale (SUS)

  Pre (baseline) and post-intervention (30 days after)

• Patient Satisfaction

  Pre (baseline) and post-intervention (30 days after)

• Resource consumption

  Through study completion (8 months)

Study Arms (1)

ARC intellicare

EXPERIMENTAL

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

Interventions

ARC intellicare DEVICE

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.

ARC intellicare

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Men and women\> 18 years,
• 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
• Informed consent signed

You may not qualify if:

• Fever (TC ≥ 37 ° C)
• Cough, cold, sore throat, diarrhoea or pneumonia signs and diagnosis
• People with moderate to severe cognitive impairment (MoCA \<20)
• Formal rehabilitation performed in the last month
• Pre-existing disability related to neurodegenerative disorders or severe stroke (TACI); epilepsy, seizures and a history of severe dizziness and falls.
• 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.
• 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
• \. Pregnancy

Sponsors & Collaborators

• Camlin Ltd: lead
• Università Politecnica delle Marche: collaborator

Study Sites (1)

Università Politecnica delle Marche

Ancona, 60126, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Maria G Ceravolo, Prof.

  Università Politecnica delle Marche, Ancona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 12, 2021
• Study Start: March 26, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

IT (1)