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In the last 5 years, the available literature evidence has indicated that, in terms of clinical efficacy, telerehabilitation can give comparable results compared to face-to-face rehabilitation. Studies of post-stroke patients have revealed some benefits of telerehabilitation, such as the ability for patients to self-record pain, mood and activity. Telerehabilitation has comparable efficacy to face-to-face rehabilitation for the recovery of some abilities, such as motor function, Activities of Daily Living (ADL), and independence; it is less effective, however, for the recovery of balance control. Published reviews concerning, in particular, neurological/neurodegenerative diseases show that telerehabilitation systems are effective in maintaining and/or improving some motor aspects, such as balance and gait, and non-motor aspects, such as mood and quality of life; they also increase patient satisfaction, so in the long term they appear to be beneficial, convenient and satisfying for patients and operators.
ARC Intellicare is a device undergoing certification as a Class I Medical Device (DM), already clinically tested during two uncontrolled clinical feasibility studies: ARCANGEL study (post-stroke, ClinicalTrials.gov Identifier: NCT03787433) and RICOMINCIARE study (post-COVID19 and Parkinson's disease, ClinicalTrials.gov Identifier: NCT05074771).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rehabilitation with ARC Intellicare Device | Experimental | rehabilitation exercise for 8 weeks using wearable devices |
|
| Rehabilitation with exercise sheet | Active Comparator | rehabilitation exercise for 8 weeks using rehabilitation exercise sheets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARC Intellicare | Device | wearable devices to guide rehabilitation exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy outcome: Six minutes walking test (6MWT) | number of meters walked in brisk 6 minutes walk | 8 weeks |
| Efficacy outcome: Borg scale | score 0-20 of perceived effort during a motor task (higher scores mean a better or worse outcome) | 8 weeks |
| safety outcome: adverse event frequency | number of adverse events reported | 8 weeks |
| Usability outcome: adherence to prescription | percent of rehabilitation sessions completed | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| policlinico Universitario A Gemelli | Roma | Rome | 00168 | Italy |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009103 | Multiple Sclerosis |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Early feasibility study
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| Rehabilitation sheets | Other | rehabilitation exercise sheets to guide rehabilitation exercise |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |