Home-based telerehabilitation for stroke patients
Telerehabilitation With Digital Technologies for the Continuum of Care of Stroke Patients: a Multicentre Randomized Controlled Trial on Effectiveness, Acceptability, Usability, and Economic Sustainability
NA · Fondazione Don Carlo Gnocchi Onlus · NCT06978413
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus (other) |
| Locations | 13 sites (Acerenza and 12 other locations) |
| Trial ID | NCT06978413 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with unstable clinical conditions or severe cognitive impairments that hinder compliance may not benefit from this study.
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 performed: Other studies have shown promising results with telerehabilitation approaches, indicating potential for success in this novel application.
Eligibility criteria
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 this trial is running
Acerenza and 12 other locations
- 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)
- 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 della Provvidenza — Rome, 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 (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, rehabilitation, telerehabilitation, digital technologies, home-based