Clinical trial NCT06978413: Telerehabilitation With Digital Technologies for the Continuum of Care of 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: rehabilitation
telerehabilitation
digital technologies
home-based
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Istituti Clinici Scientifici Maugeri SpA
name: IRCCS National Neurological Institute "C. Mondino" Foundation
name: Ospedale Policlinico San Martino
name: Cure Ortopediche Traumatologiche SpA
name: Università di Pavia
name: Scuola Superiore Sant'Anna di Pisa
name: Campus Bio-Medico University
First posted: 2025-05-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The aim of the study is to evaluate the effectiveness of a home-based treatment based on rehabilitation technologies by comparing it with a traditional educational program at home.

Primary objective: Demonstration of the superiority of a home-based rehabilitation program with digital tools (home-based technological telerehabilitation) over a home-based educational program (home-based usual care) in patients with stroke outcomes in improving static and dynamic balance.

Secondary objectives:

* Evaluation of the impact of the frequency of the intervention on recovery;
* Evaluation of the acceptability of the intervention with digital tools for the patient, the caregiver, and the health care provider;
* Evaluation of the usability of the intervention with digital tools for the patient and the caregiver;
* Evaluation of the economic sustainability of the integrated rehabilitation intervention with digital tools for the patient, the payer, and society through the creation of a cost-effectiveness, cost-utility, and, for the health system, budget impact analysis model evaluation and prediction, and related sensitivity analyses.

The study is designed as a multicenter, multimodal, randomized, controlled, parallel group (1:1), blinded interventional trial. It will be conducted at multiple clinical centers participating in a national research initiative. Randomization will be centralized and stratified by clinical center, time since stroke, and age.

The sample size was determined using a 2-tailed, 2-sample t-test, assuming a power of 80%, a type I error t of 0.05, a mean difference of 2.7 units on the primary outcome (specifically, the change in the Berg Balance Scale, corresponding to the minimum detectable change in chronic stroke patients) and a common standard deviation of 5.37 points. With these assumptions, a sample size of 128 cases was estimated. Further, considering a dropout rate of 20%, the final estimated sample size required is 160 cases. The calculation was performed using G\*Power software.

All participating centers will follow a standardized operating procedure regarding treatment and outcome assessment to ensure consistency across all sites. Data will be systematically collected using the REDCap (Research Electronic Data Capture) platform.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in the Berg Balance Scale (BBS)
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Secondary outcomes:
measure: Fugl-Meyer Assessment for the upper extremities - motor function
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Fugl-Meyer Assessment for the upper extremities - sensory function
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Fugl-Meyer Assessment for the lower extremities - motor function
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Fugl-Meyer Assessment for the lower extremities - sensory function
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Modified Rivermead Motricity Index
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Symbol Digit Modalities Test
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Modified Barthel Index
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Modified Ashworth Scale
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Motricity Index for upper extremities
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Motricity Index for lower extremities
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Trunk control test
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Numerical Rating Scale for Pain
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Neuropathic Pain 4 Questions
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Functional Ambulation Classification Scale
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Frontal Assessment Battery
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: World Health Organization disability assessment schedule 2.0 - WHODAS 2.0
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: 5-level EQ-5D version (EQ-5D-5L)
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Other outcomes:
measure: premorbid Modified Rankin Scale
timeFrame: Baseline
measure: Montreal Cognitive Assessment Scale
timeFrame: Baseline
measure: Timed Up and Go
timeFrame: Baseline
measure: Computer skills questionnaire
timeFrame: Baseline
measure: Technology Acceptance Model
timeFrame: Within 7 days after the end of the 6-week observation/rehabilitation period
measure: Questionnaire for satisfaction
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: System Usability Scale - SUS
timeFrame: Within 7 days after the end of the 6-week observation/rehabilitation period
measure: Questionnaire for costs
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Questionnaire for perception of problems and solution complexity
timeFrame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
measure: Incremental cost-utility ratio
timeFrame: During the study, an average of 14 months
measure: Incremental cost-effectiveness ratio
timeFrame: During the study, an average of 14 months
measure: Financial impact (differences in direct health costs)
timeFrame: During the study, an average of 14 months
measure: Working-Related Quality of Life
timeFrame: During the study, an average of 14 months
Locations:
city: Acerenza
country: Italy
facility: Fondazione Don Carlo Gnocchi, Centro Gala
city: Bari
country: Italy
facility: IRCCS Istituti Clinici Scientifici Maugeri
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Messina
country: Italy
facility: COT, Cure Ortopediche Traumatologiche, Istituto Clinico Polispecialistico
city: Milan
country: Italy
facility: Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente
city: Milan
country: Italy
facility: IRCCS Istituti Clinici Scientifici Maugeri
city: Montescano
country: Italy
facility: IRCCS Istituti Clinici Scientifici Maugeri
city: Pavia
country: Italy
facility: IRCCS Fondazione Mondino
city: Rome
country: Italy
facility: Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza
city: Salerno
country: Italy
facility: Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare
city: Sant'Angelo Dei Lombardi
country: Italy
facility: Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
city: Telese Terme
country: Italy
facility: IRCCS Istituti Clinici Scientifici Maugeri
city: Tricarico
country: Italy
facility: Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi
name: Irene G Aprile, MD, PhD
role: STUDY_DIRECTOR
affiliation: IRCCS Istituti Clinici Scientifici Maugeri
name: Christian Lunetta
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Fondazione Mondino
name: Roberto De Icco
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Ospedale Policlinico San Martino
name: Carlo Trompetto
role: PRINCIPAL_INVESTIGATOR
affiliation: COT Istituto Clinico Polispecialistico
name: Ennio Ferlazzo
role: PRINCIPAL_INVESTIGATOR
affiliation: Università di Pavia
name: Silvana Quaglini
role: PRINCIPAL_INVESTIGATOR
affiliation: Università Sant'Anna di Pisa
name: Giuseppe Turchetti
role: PRINCIPAL_INVESTIGATOR
affiliation: Campus Bio-Medico University
name: Leandro Pecchia
role: PRINCIPAL_INVESTIGATOR
References: