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RECRUITING
NCT06547827
NA

Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients

Sponsor: Fondazione Don Carlo Gnocchi Onlus

View on ClinicalTrials.gov

Summary

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.

Official title: Rehabilitation With and Without Robot and Allied Digital Technologies (RADTs) in Stroke Patients: a Pragmatic Multicenter Randomised Controlled Trial on the Effectiveness, Acceptability, Usability, and Economic-organizational Sustainability of RADTs From Subacute to Chronic Phase

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

596

Start Date

2024-08-12

Completion Date

2026-07-31

Last Updated

2025-02-12

Healthy Volunteers

No

Conditions

Interventions

OTHER

robotic rehabilitation

Treatment will occur in a gym equipped with devices for all the domains, with two physiotherapists supervising groups of 4 to 6 patients, depending on their clinical severity. Patients will undergo a total of 25 sessions, each lasting 45 minutes, with the following frequency: * 5 times a week for 5 weeks, for inpatients; * 3 times a week for 8.3 weeks, for outpatients.

OTHER

traditional rehabilitation

A physiotherapist-to-patient ratio of 1:1 is provided for the treatment in all participating centres. Patients will undergo a total of 25 sessions, each lasting 45 minutes, with the following frequency: * 5 times a week for 5 weeks, for inpatients; * 3 times a week for 8.3 weeks, for outpatients.

Locations (13)

Fondazione Don Carlo Gnocchi, Centro Gala

Acerenza, Italy

IRCCS Istituti Clinici Scientifici Maugeri

Bari, Italy

IRCCS Ospedale Policlinico San Martino,

Genova, Italy

Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente

Milan, Italy

IRCCS Istituti Clinici Scientifici Maugeri

Milan, Italy

IRCCS Istituti Clinici Scientifici Maugeri

Montescano, Italy

IRCCS Fondazione Mondino

Pavia, Italy

IRCCS Istituti Clinici Scientifici Maugeri

Pavia, Italy

Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza

Roma, Italy

Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare

Salerno, Italy

Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo

Sant'Angelo dei Lombardi, Italy

IRCCS Istituti Clinici Scientifici Maugeri

Telese Terme, Italy

Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo

Tricarico, Italy