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

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.

Conditions

• Stroke

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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA

  collaborator OTHER

• IRCCS National Neurological Institute "C. Mondino" Foundation

  collaborator OTHER

• Ospedale Policlinico San Martino

  collaborator OTHER

• Università di Pavia

  collaborator UNKNOWN

• Scuola Superiore Sant'Anna di Pisa

  collaborator OTHER

• Fondazione Don Carlo Gnocchi Onlus

  lead OTHER

Principal Investigators

• Irene G Aprile · IRCCS Fondazione Don Carlo Gnocchi

• Irene G Aprile · IRCCS Fondazione Don Carlo Gnocchi

• Christian Lunetta · IRCCS Istituti Clinici Scientifici Maugeri

• Roberto De Icco · IRCCS Fondazione Mondino

• Carlo Trompetto · IRCCS Ospedale Policlinico San Martino

• Silvana Quaglini · Università di Pavia

• Giuseppe Turchetti · Scuola Superiore Sant'Anna di Pisa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-12

Primary Completion

2026-01-31

Completion

2026-07-31

Countries

• Italy

Study Locations