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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Treatment with Digital Tools

The experimental treatment involves home-based telerehabilitation protocols utilizing digital tools. Patients will perform task-oriented activities aimed at improving balance through standing and/or seated exercises under both static and dynamic conditions. Exercise complexity will be progressively adapted and personalized based on the patient's performance, improvement trajectory, and instrumental feedback from the digital system.

All devices must have a CE mark for medical devices and be used according to the manufacturer's specifications.

Group Type EXPERIMENTAL

Integrated Treatment with Digital Tools

Intervention Type OTHER

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.

Educational Program

Patients in the Control Group will follow a self-guided educational program supported by printed materials outlining daily living activities to be performed at home.

Group Type ACTIVE_COMPARATOR

Home-Based Educational Program

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irene G Aprile, MD, PhD

Role: STUDY_DIRECTOR

IRCCS Fondazione Don Carlo Gnocchi

Christian Lunetta

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituti Clinici Scientifici Maugeri

Roberto De Icco

Role: PRINCIPAL_INVESTIGATOR

IRCCS Fondazione Mondino

Carlo Trompetto

Role: PRINCIPAL_INVESTIGATOR

IRCCS Ospedale Policlinico San Martino

Ennio Ferlazzo

Role: PRINCIPAL_INVESTIGATOR

COT Istituto Clinico Polispecialistico

Silvana Quaglini

Role: PRINCIPAL_INVESTIGATOR

Università di Pavia

Giuseppe Turchetti

Role: PRINCIPAL_INVESTIGATOR

Università Sant'Anna di Pisa

Leandro Pecchia

Role: PRINCIPAL_INVESTIGATOR

Campus Bio-Medico University

Locations

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