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

NCT06978413 | Recruiting DMC

• 2 other identifiers: Fit4MedRobStroke@HomePNC0000007
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 13

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.

Conditions

Stroke

Keywords

rehabilitation; telerehabilitation; digital technologies; home-based

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the Berg Balance Scale (BBS)

  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.

  Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

Secondary Outcomes (17)

• Fugl-Meyer Assessment for the upper extremities - motor function

  Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

• Fugl-Meyer Assessment for the upper extremities - sensory function

  Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

• Fugl-Meyer Assessment for the lower extremities - motor function

  Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

• Fugl-Meyer Assessment for the lower extremities - sensory function

  Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

• Modified Rivermead Motricity Index

  Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

Other Outcomes (13)

• premorbid Modified Rankin Scale

  Baseline

• Montreal Cognitive Assessment Scale

  Baseline

• Timed Up and Go

  Baseline

Study Arms (2)

Treatment with Digital Tools

EXPERIMENTAL

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.

Other: Integrated Treatment with Digital Tools

Educational Program

ACTIVE COMPARATOR

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.

Other: Home-Based Educational Program

Interventions

Integrated Treatment with Digital Tools 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.

Treatment with Digital Tools

Home-Based Educational Program 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.

Educational Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Istituti Clinici Scientifici Maugeri SpA: collaborator
• IRCCS National Neurological Institute "C. Mondino" Foundation: collaborator
• Ospedale Policlinico San Martino: collaborator
• C.O.T. Cure Ortopediche Traumatologiche S.p.A.: collaborator
• Università di Pavia: collaborator
• Scuola Superiore Sant'Anna di Pisa: collaborator
• Campus Bio-Medico University: collaborator

Study Sites (13)

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

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Irene G Aprile, MD, PhD

  IRCCS Fondazione Don Carlo Gnocchi

  STUDY DIRECTOR

• Christian Lunetta

  IRCCS Istituti Clinici Scientifici Maugeri

  PRINCIPAL INVESTIGATOR

• Roberto De Icco

  IRCCS Fondazione Mondino

  PRINCIPAL INVESTIGATOR

• Carlo Trompetto

  IRCCS Ospedale Policlinico San Martino

  PRINCIPAL INVESTIGATOR

• Ennio Ferlazzo

  COT Istituto Clinico Polispecialistico

  PRINCIPAL INVESTIGATOR

• Silvana Quaglini

  Università di Pavia

  PRINCIPAL INVESTIGATOR

• Giuseppe Turchetti

  Università Sant'Anna di Pisa

  PRINCIPAL INVESTIGATOR

• Leandro Pecchia

  Campus Bio-Medico University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene G Aprile, MD, PhD

CONTACT

+390633086553; iaprile@dongnocchi.it

Marco Germanotta, PhD

CONTACT

+390633086553; mgermanotta@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 18, 2025
• Study Start: May 20, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning six months after the publication, with no end date.
• Access Criteria: Access will be provided to the general scientific community and any interested researchers, for any type of analysis or secondary research use. The data will be made available on a public data-sharing platform such as Zenodo, or Figshare.

Locations

IT (13)