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Recruiting Not applicable

Telerehabilitation With Digital Technologies for the Continuum of Care of Stroke Patients

NCT06978413 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-05-20
Last updated
2025-05-30

Condition(s) studied

Stroke

Investigational drug(s) / intervention(s)

Integrated Treatment with Digital ToolsHome-Based Educational Program

Integrated Treatment with Digital Tools: Patients will undergo a 6-week remote telerehabilitation program. The recommended frequency of treatment is a minimum of 3 sessions per week, but patients may adjust the schedule in agreement with their assigned therapist. If a patient is unable to complete at least 18 sessions due to clinical reasons, they will be considered as a dropout. Moreover, one session per week will be conducted synchronously, with the therapist remotely supervising the patient's activities in real time, while the remaining sessions will be asynchronous, allowing the patient to complete the exercises independently.

Home-Based Educational Program: Patients will be monitored over a six-week period through weekly phone calls to assess their progress and overall condition. Additionally, participants are required to maintain an activity diary to document their engagement with the prescribed activities.

Study summary

The goal of the pragmatic study is to evaluate the effectiveness of a home-based telerehabilitation protocol for patients with post-stroke disabilities, compared to a home-based educational program.

The main question it aims to answer is:

Is home-based neuromotor and cognitive rehabilitation using digital tools more effective than a traditional educational program for improving static and dynamic balance in patients with subacute and chronic stroke? Researchers will compare the outcome (Berg Balance Scale) measured at baseline with the outcome after treatment to test its effectiveness.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change from baseline in the Berg Balance Scale (BBS) — Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
    The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.

Trial sites (13)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06978413 on ClinicalTrials.gov ↗ ← All trials in Italy