Telerehabilitation With Digital Technologies for the Continuum of Care of Stroke Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Integrated Treatment with Digital Tools, Home-Based Educational Program.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other 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 rema - 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.
Primary outcome measures
- Change from baseline in the Berg Balance Scale (BBS) [Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period]
Secondary outcome measures (12)
- Fugl-Meyer Assessment for the upper extremities - motor function [Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period]
- Fugl-Meyer Assessment for the upper extremities - sensory function [Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period]
- Fugl-Meyer Assessment for the lower extremities - motor function [Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period]
- Fugl-Meyer Assessment for the lower extremities - sensory function [Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period]
- Modified Rivermead Motricity Index [Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period]
- Symbol Digit Modalities Test [Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period]
- Modified Barthel Index [Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period]
- Modified Ashworth Scale [Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period]
- Motricity Index for upper extremities [Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period]
- Motricity Index for lower extremities [Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period]
- Trunk control test [Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period]
- Numerical Rating Scale for Pain [Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 13 centers
- Fondazione Don Carlo Gnocchi, Centro Gala — Acerenza
- IRCCS Istituti Clinici Scientifici Maugeri — Bari
- IRCCS Ospedale Policlinico San Martino — Genova
- COT, Cure Ortopediche Traumatologiche, Istituto Clinico Polispecialistico — Messina
- Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente — Milan
- IRCCS Istituti Clinici Scientifici Maugeri — Milan
- IRCCS Istituti Clinici Scientifici Maugeri — Montescano
- IRCCS Fondazione Mondino — Pavia
- … and 5 more centers
Identifiers
NCT: NCT06978413 · Fit4MedRobStroke@Home · PNC0000007