At Home REhabilitation and Monitoring of People in poST-covid Condition Through ARc-inTellicare Platform (RESTART/RICOMINCIARE) (RICOMINCIARE)
Post-COVID19, Parkinson Disease
About this trial
This is an interventional device feasibility trial for Post-COVID19 focused on measuring COVID19 Parkinson Home Rehabilitation
Eligibility 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:
- 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
Exclusion Criteria:
- 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
9. Pregnancy
Sites / Locations
- Università Politecnica delle Marche
Arms of the Study
Arm 1
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.