Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Home-based telerehabilitation for stroke patients

Official title: Telerehabilitation With Digital Technologies for the Continuum of Care of Stroke Patients: a Multicentre Randomized Controlled Trial on Effectiveness, Acceptability, Usability, and Economic Sustainability

Run by Fondazione Don Carlo Gnocchi ETS · NCT06978413 · Data updated 2026-11-12

This study is testing whether a home-based digital rehabilitation program can help stroke patients improve their balance better than a traditional educational program.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment160 (estimated)
SponsorFondazione Don Carlo Gnocchi ETS
Academic / other
Locations13 sites (Acerenza and 12 other locations)
StatusRecruiting
StartedMay 20, 2025
Main results expectedMay 1, 2026
Study endsJuly 31, 2026
Registry record updatedMay 30, 2025
Trial IDNCT06978413 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years who have experienced their first ischemic or hemorrhagic stroke and are within 3 to 24 months post-event.

Probably not a fit

Patients with unstable clinical conditions or severe cognitive impairments that hinder compliance may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a home-based telerehabilitation program using digital technologies for patients with post-stroke disabilities, comparing it to a traditional home-based educational program. The primary objective is to determine if the digital rehabilitation approach is superior in improving static and dynamic balance, as measured by the Berg Balance Scale. The study employs a multicenter, randomized, controlled design, with participants stratified by clinical center, time since stroke, and age. Secondary objectives include assessing the intervention's frequency, acceptability, usability, and economic sustainability.

Why it matters

Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes for stroke patients, improving their balance and overall quality of life.

How similar studies have gone: Other studies have shown promising results with telerehabilitation approaches, indicating potential for success in this novel application.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosis of first ischemic or hemorrhagic stroke verified by Computed Axial Tomography or MRI.
* Age greater than 18 years.
* Latency since the event: a) greater than 3 months and less than or equal to 6 months; b) greater than 6 months and less than 24 months.
* Ability to perform the Timed Up and Go Test.

Exclusion Criteria:

* Unstable clinical conditions.
* Behavioral/cognitive disorders that prevent adequate patient compliance with the study (severe cognitive impairment, Montreal Cognitive Assessment\<17.5).
* Severe visual impairment that cannot be corrected by lenses, preventing the patient from performing treatment with digital instruments.
* Refusal to sign informed consent.

Where it's running

  • Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza
    Rome, Italy
    Recruiting
  • Fondazione Don Carlo Gnocchi, Centro Gala
    Acerenza, Italy
    Not yet recruiting
  • IRCCS Istituti Clinici Scientifici Maugeri
    Bari, Italy
    Not yet recruiting
  • IRCCS Ospedale Policlinico San Martino
    Genova, Italy
    Not yet recruiting
  • COT, Cure Ortopediche Traumatologiche, Istituto Clinico Polispecialistico
    Messina, Italy
    Not yet recruiting
  • Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente
    Milan, Italy
    Not yet recruiting
Show 7 more locations
  • IRCCS Istituti Clinici Scientifici Maugeri
    Milan, Italy
    Not yet recruiting
  • IRCCS Istituti Clinici Scientifici Maugeri
    Montescano, Italy
    Not yet recruiting
  • IRCCS Fondazione Mondino
    Pavia, Italy
    Not yet 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
    Not yet recruiting
  • IRCCS Istituti Clinici Scientifici Maugeri
    Telese Terme, Italy
    Not yet recruiting
  • Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo
    Tricarico, Italy
    Not yet recruiting

Study contacts

  • Principal investigator: Christian Lunetta — IRCCS Istituti Clinici Scientifici Maugeri
  • Study coordinator: Irene G Aprile, MD, PhD
  • Email: iaprile@dongnocchi.it
  • Phone: +390633086553

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.