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Clinical Trials in Italy / NCT07159854
Starting soon Not applicable

Telerehabilitation in Central and Peripheral Neurological Sequelae From Chemotherapy

NCT07159854 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Don Carlo Gnocchi ETS
Phase
Not applicable
Started
2025-09-01
Last updated
2025-09-08

Condition(s) studied

Chemotherapy-induced Neurotoxicity

Investigational drug(s) / intervention(s)

RICORDO-DTx systemHOMING systemHome-based training program

RICORDO-DTx system: Participants with will undergo a cognitive enhancement program using the Astir RICORDO-DTx system (http://www.ricordo-dtx.com), which allows for the personalization of rehabilitative content based on the needs of the target population and can be delivered remotely.

HOMING system: Participants will also undergo motor rehabilitation sessions focused on improving balance, gait, and muscular endurance using the HOMING system (https://www.tecnobody.com/homing).

Home-based training program: Subjects will view videos on Tablet. The treatment will be provided via a digital medicine platform on a mobile device (tablet).

Study summary

The goal of this clinical trial is to validate the use of innovative tele-rehabilitation (TR) models in terms of efficiency and effectiveness in a pilot cohort of subjects with central and peripheral chemotherapy-induced neurotoxicity. Participants will be randomized (with an allocation ratio of 1:1) into the experimental group (TRUST\_ME - 15 sessions of motor and cognitive activities delivered at home through a TR approach using the Maia platform) and Treatment as Usual (15 sessions of multimedia content of educational/rehabilitation activities delivered via telemedicine platfom). It expected that the TR system to be considered acceptable in terms of efficiency (usability and acceptability of the technologies) and clinically effective, with positive impacts on both quality of life and central and peripheral functioning in these patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult subjects (\>18 years old) with central and/or peripheral neurotoxic sequelae following a history of cancer treated with chemotherapeutic agents (Cisplatin and Taxanes), in accordance with the criteria of the International Cognitive Cancer Task Force (Wefel et al., 2011. 10.1016/S1470-2045(10)70294-1) * agreement to participate with the signature of the informed consent form; Exclusion Criteria: * Ongoing chemotherapy treatment; * Pre-existing neurological or psychiatric comorbidities (e.g., epilepsy, post-stroke disability, neurodegenerative diseases, genetically based polyneuropathy); * Severe visual or hearing impairments that could interfere with the use of technology; * Severe cognitive impairment (Mini-Mental State Examination score \<18); * Severe postural disability associated with a high risk of falling at home, as documented in the clinical evaluation; * Contraindications to undergoing MRI examination; * Ongoing rehabilitation treatment.

Primary outcome measure(s)

  • Changes in Activation level of Patients measured by Patient Activation Measure 13 (PAM13; Hibbard et al., 2004) — Time Frame: Baseline, post-treatment (up to 5 weeks)
    PAM13 is a 13-item scale that assesses a person's underlying knowledge, skills and confidence integral to managing his or her health and healthcare. PAM13 total score ranging from 0 to 100. Higher values represent a better outcome. Specifically, individuals in the lowest activation level do not yet understand the importance of their role in managing their health and have significant knowledge gaps and limited self-management skills. Individuals in the highest activation level are proactive with their health, have developed strong self- management skills, and are resilient in times of stress or change.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Fondazione Don Carlo Gnocchi ONLUS Milan Italy

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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 NCT07159854 on ClinicalTrials.gov ↗ ← All trials in Italy