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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Fondazione Don Carlo Gnocchi ETS Academic / other |
| Locations | 13 sites (Acerenza and 12 other locations) |
| Status | Recruiting |
| Started | May 20, 2025 |
| Main results expected | May 1, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | May 30, 2025 |
| Trial ID | NCT06978413 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
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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
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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.
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Deep phenotyping to explore recovery in young adults after stroke
This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.
-
Stem cell therapy for chronic stroke recovery
This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.
-
AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals
This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.
-
Web-based therapy using action observation and mirror therapy for arm weakness after stroke
This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.
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Remote Ischaemic Conditioning for Fatigue After Stroke 2
Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.
-
Dual-task balance training plus computer-based cognitive training after stroke
In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.