Actively Recruiting
Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-02-12
596
Participants Needed
13
Research Sites
102 weeks
Total Duration
On this page
Sponsors
F
Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
I
Istituti Clinici Scientifici Maugeri SpA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Rehabilitation after stroke often employs Robot and Allied Digital Technologies (RADTs), yet evidence on their effectiveness remains inconclusive due to study heterogeneity and limited sample sizes. This multicentre randomized controlled pragmatic trial aims at comprehensively and accurately assessing the effectiveness of rehabilitation mediated by RADTs after a stroke, compared to traditional rehabilitation, also considering economic sustainability.
CONDITIONS
Official Title
Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- First-ever diagnosis of ischemic or haemorrhagic stroke confirmed by CT or MRI
- Age 18 years and over
- Stroke occurred within 6 months prior to enrollment
- Mild to severe impairment of upper limb (Fugl-Meyer Assessment motor section 58) and/or lower limb (Functional Ambulation Categories scale 4) and/or balance (Berg Balance Scale 45)
- Clinically stable to allow transfer to gym and perform treatments
You will not qualify if you...
- Clinical instability
- Severe cognitive or behavioral disorders preventing compliance (Montreal Cognitive Assessment <10)
- Rigidity or hypertonia (Modified Ashworth Scale > 3) in affected limb
- Serious uncorrectable visual impairments preventing use of technological or robotic devices
- Pregnant women
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Fondazione Don Carlo Gnocchi, Centro Gala
Acerenza, Italy
Actively Recruiting
2
IRCCS Istituti Clinici Scientifici Maugeri
Bari, Italy
Not Yet Recruiting
3
IRCCS Ospedale Policlinico San Martino,
Genova, Italy
Actively Recruiting
4
Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente
Milan, Italy
Not Yet Recruiting
5
IRCCS Istituti Clinici Scientifici Maugeri
Milan, Italy
Not Yet Recruiting
6
IRCCS Istituti Clinici Scientifici Maugeri
Montescano, Italy
Actively Recruiting
7
IRCCS Fondazione Mondino
Pavia, Italy
Actively Recruiting
8
IRCCS Istituti Clinici Scientifici Maugeri
Pavia, Italy
Actively Recruiting
9
Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza
Roma, Italy
Actively Recruiting
10
Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare
Salerno, Italy
Not Yet Recruiting
11
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
Sant'Angelo dei Lombardi, Italy
Actively Recruiting
12
IRCCS Istituti Clinici Scientifici Maugeri
Telese Terme, Italy
Not Yet Recruiting
13
Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo
Tricarico, Italy
Actively Recruiting
Research Team
I
Irene G Aprile, MD, PhD
CONTACT
M
Marco Germanotta, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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