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

NCT06547827 | Recruiting DMC

• 2 other identifiers: FIT4MedRobStrokePNC0000007
• Study Type: interventional
• Target: 596
• Locations: 1 country
• Sites: 13

Brief 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

Keywords

rehabilitation; robotics

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the modified Barthel Index

  The modified Barthel Index for Activities of Daily Living is a validated ordinal scale which measures a person's ability to complete activities of daily living (ADL). Scores range from 0 (total dependence) to 100 (total independence).

  baseline; within 24 hours from the 25th rehabilitation session

Secondary Outcomes (24)

• Fugl-Meyer Assessment for the upper extremities - motor function

  baseline; within 24 hours from the 25th rehabilitation session

• Fugl-Meyer Assessment for the upper extremities - sensory function

  baseline; within 24 hours from the 25th rehabilitation session

• Fugl-Meyer Assessment for the lower extremities - motor function

  baseline; within 24 hours from the 25th rehabilitation session

• Fugl-Meyer Assessment for the lower extremities - sensory function

  baseline; within 24 hours from the 25th rehabilitation session

• Berg Balance Scale

  baseline; within 24 hours from the 25th rehabilitation session

Other Outcomes (28)

• premorbid Modified Rankin Scale

  At baseline

• Life Time Physical Activity Questionnaire

  At baseline

• Cognitive Reserve Index

  At baseline

Study Arms (2)

Integrated Treatment with Robotic & Technological Devices (RADTs)

EXPERIMENTAL

This intervention employs various RADTs to target the following domains: a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; and d) cognitive abilities. For upper limb sensorimotor function, we will use planar end-effector robots, exoskeletons, or electromechanical systems for shoulder, elbow, and wrist rehabilitation; end-effector robots or exoskeletons for hand rehabilitation; and sensor-based devices for comprehensive upper limb treatment. For lower limb sensorimotor function, we will utilize end-effector robots or exoskeletons and treadmills with body-weight support systems. Balance training will involve stabilometric platforms and sensor-based systems. Cognitive functions will be addressed using digital systems, sensor-based devices, and virtual reality programs. All devices must have a CE mark for medical devices and be used according to the manufacturer's specifications.

Other: robotic rehabilitation

Traditional Treatment

ACTIVE COMPARATOR

In the control group, subjects will undergo a standard traditional rehabilitation program without the use of RADTs, focusing on the following domains:a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; and d) cognitive abilities, using traditional methods of physiotherapy and cognitive rehabilitation.

Other: traditional rehabilitation

Interventions

robotic rehabilitation OTHER

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.

Integrated Treatment with Robotic & Technological Devices (RADTs)

traditional rehabilitation OTHER

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.

Traditional Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-ever diagnosis of ischemic or haemorrhagic stroke confirmed by Computed Tomography or Magnetic Resonance Imaging;
• Age 18 years and over;
• Time since the event equal to or less than 6 months;
• Mild to severe impairment of the upper limb (motor section of the Fugl-Meyer Assessment of Upper Extremity ≤ 58) and/or mild to severe impairment of the lower limb (score on the Functional Ambulation Categories scale ≤ 4) and/or mild to severe impairment of balance (Berg Balance Scale ≤ 45);
• Clinical stability allowing transfer to the gym and execution of the planned treatments.

You may not qualify if:

• Clinical instability;
• Behavioral/cognitive disorders preventing adequate patient compliance with both traditional and robotic rehabilitation treatment (severe cognitive deficit, Montreal Cognitive Assessment \<10);
• Rigidity or hypertonia (Modified Ashworth Scale \> 3) in the plegic/paretic limb;
• Serious uncorrectable visual impairments preventing the patient from performing treatment with technological and/or robotic devices;
• Pregnant women;
• Refusal to sign the informed consent.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Istituti Clinici Scientifici Maugeri SpA: collaborator
• IRCCS National Neurological Institute "C. Mondino" Foundation: collaborator
• Ospedale Policlinico San Martino: collaborator
• Università di Pavia: collaborator
• Scuola Superiore Sant'Anna di Pisa: collaborator

Study Sites (13)

Fondazione Don Carlo Gnocchi, Centro Gala

Acerenza, Italy

RECRUITING

IRCCS Istituti Clinici Scientifici Maugeri

Bari, Italy

NOT YET RECRUITING

IRCCS Ospedale Policlinico San Martino,

Genova, Italy

RECRUITING

Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente

Milan, Italy

NOT YET RECRUITING

IRCCS Istituti Clinici Scientifici Maugeri

Milan, Italy

NOT YET RECRUITING

IRCCS Istituti Clinici Scientifici Maugeri

Montescano, Italy

RECRUITING

IRCCS Fondazione Mondino

Pavia, Italy

RECRUITING

IRCCS Istituti Clinici Scientifici Maugeri

Pavia, Italy

RECRUITING

Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza

Roma, Italy

RECRUITING

Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare

Salerno, Italy

NOT YET RECRUITING

Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo

Sant'Angelo dei Lombardi, Italy

RECRUITING

IRCCS Istituti Clinici Scientifici Maugeri

Telese Terme, Italy

NOT YET RECRUITING

Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo

Tricarico, Italy

RECRUITING

Related Publications (1)

• Aprile IG, Germanotta M, Fasano A, Siotto M, Mauro MC, Pavan A, Nicora G, Sgandurra G, Malovini A, Oreni L, Dubbini N, Parimbelli E, Comande G, Lunetta C, Fiore P, De Icco R, Trompetto C, Trieste L, Turchetti G, Quaglini S, Messa C; STROKEFIT4 Study Group. Rehabilitation with and Without Robot and Allied Digital Technologies (RADTs) in Stroke Patients: A Study Protocol for a Multicentre Randomised Controlled Trial on the Effectiveness, Acceptability, Usability, and Economic-Organisational Sustainability of RADTs from Subacute to Chronic Phase (STROKEFIT4). J Clin Med. 2025 Apr 15;14(8):2692. doi: 10.3390/jcm14082692.

  PMID: 40283522 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Irene G Aprile

  IRCCS Fondazione Don Carlo Gnocchi

  STUDY DIRECTOR

• Irene G Aprile

  IRCCS Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

• Christian Lunetta

  IRCCS Istituti Clinici Scientifici Maugeri

  PRINCIPAL INVESTIGATOR

• Roberto De Icco

  IRCCS Fondazione Mondino

  PRINCIPAL INVESTIGATOR

• Carlo Trompetto

  IRCCS Ospedale Policlinico San Martino

  PRINCIPAL INVESTIGATOR

• Silvana Quaglini

  Università di Pavia

  PRINCIPAL INVESTIGATOR

• Giuseppe Turchetti

  Scuola Superiore Sant'Anna di Pisa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene G Aprile, MD, PhD

CONTACT

+390633086553; iaprile@dongnocchi.it

Marco Germanotta, PhD

CONTACT

+390633086553; mgermanotta@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 9, 2024
• Study Start: August 12, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning six months after the publication, with no end date.
• Access Criteria: Access will be provided to the general scientific community and any interested researchers, for any type of analysis or secondary research use. The data will be made available on a public data-sharing platform such as Zenodo, or Figshare.

Locations

IT (13)