Actively Recruiting
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-02-12
596
Participants Needed
13
Research Sites
30 weeks
Total Duration
F
Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
I
Istituti Clinici Scientifici Maugeri SpA
Collaborating Sponsor
Researchers are evaluating the effectiveness of rehabilitation using Robot and Allied Digital Technologies (RADTs) compared to traditional rehabilitation for patients who have had a stroke within the past six months. This large pragmatic trial aims to assess whether RADTs are at least as effective as traditional therapy in helping patients recover their daily living activities. The study also examines improvements in motor and cognitive functions, neuroplasticity factors, patient and caregiver acceptance, and economic sustainability. The trial involves two groups: one receiving rehabilitation with RADTs and another receiving traditional one-on-one therapy. The RADT group uses various devices such as robotic exoskeletons, end-effector robots, sensor-based systems, treadmills with body-weight support, stabilometric platforms, and virtual reality programs targeting upper and lower limb function, balance, and cognition. Both groups receive 25 sessions lasting 45 minutes each, delivered five times a week for five weeks for inpatients or three times a week for about 8.3 weeks for outpatients. Participants will be assessed at baseline and after 25 rehabilitation sessions using tools including the modified Barthel Index, Fugl-Meyer Assessment, Berg Balance Scale, cognitive tests, pain scales, walking and dexterity tests, and blood biomarkers. Follow-up assessments continue monthly for six months after treatment ends to monitor lasting effects and quality of life. Data collection is standardized across multiple centers, and the study includes safety monitoring and economic evaluations. Total study participation lasts from enrollment through the six-month follow-up period.
CONDITIONS
Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 to 8.3 weeks depending on clinical setting
Participants receive rehabilitation treatment either with robotic and technological devices or traditional methods targeting upper and lower limb abilities, balance, and cognitive functions.
25 sessions; 5 times a week for 5 weeks for inpatients or 3 times a week for approximately 8.3 weeks for outpatients
Duration - 6 months
Participants are monitored to assess the effects of the rehabilitation treatment on daily life activities and quality of life through medium-term follow-up.
Monthly visits for 6 months after treatment completion
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
I
Irene G Aprile, MD, PhD
M
Marco Germanotta, PhD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Irene Giovanna Aprile, Marco Germanotta, Alessio Fasano...
https://pubmed.ncbi.nlm.nih.gov/40283522