NCT07159854

Telerehabilitation in Central and Peripheral Neurological Sequelae From Chemotherapy

TeleRehabilitation: an Innovative User-centered STrategic Approach for the treatMent of Central and Peripheral Neurological sEquelae From Chemotherapy - TRUST_ME

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy-induced Neurotoxicity

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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).
DEVICE	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).

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-07-31
• Completion: 2026-08-31
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

1 site across 1 country: Italy