Multiple Sclerosis, Parkinson Disease, Stroke
Conditions
Brief summary
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).
Interventions
DEVICEARC Intellicare
wearable devices to guide rehabilitation exercise
OTHERRehabilitation sheets
rehabilitation exercise sheets to guide rehabilitation exercise
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Early feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients with diagnosis of Parkinson's disease with Hoehn&Yahr staging 1-3 * diagnosis of multiple sclerosis with extended disability scale score 3.5-6 * diagnosis of ischemic stroke in the past 12 months
Exclusion criteria
* history of falls * dementia * epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy outcome: Six minutes walking test (6MWT) | 8 weeks | number of meters walked in brisk 6 minutes walk |
| Efficacy outcome: Borg scale | 8 weeks | score 0-20 of perceived effort during a motor task (higher scores mean a better or worse outcome) |
| safety outcome: adverse event frequency | 8 weeks | number of adverse events reported |
| Usability outcome: adherence to prescription | 8 weeks | percent of rehabilitation sessions completed |
Countries
Italy
Outcome results
None listed