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Telerehabilitation in Central and Peripheral Neurological Sequelae From Chemotherapy

NCT07159854 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-08

No results posted yet for this 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.

Conditions

  • Chemotherapy-induced Neurotoxicity

Interventions

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).

Sponsors & Collaborators

  • Astir S.r.l.

    collaborator UNKNOWN

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Principal Investigators

  • Francesca Baglio · IRCCS Fondazione Don Carlo Gnocchi ONLUS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-07-31
Completion
2026-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07159854 on ClinicalTrials.gov