Telerehabilitation in Central and Peripheral Neurological Sequelae From Chemotherapy

NCT ID: NCT07159854

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chemotherapy-induced Neurotoxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TRUST_ME

A cycle of motor and cognitive activities delivered at home through a telerehabilitation approach using the Maia platform by ABmedica (https://abmedica.it/prodotti-ab-medica/maia). The treatment will last 5 weeks with a frequency of three sessions a week (1 synchronous and 2 asynchronous).

Group Type EXPERIMENTAL

RICORDO-DTx system

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Treatment as Usual

Home-based training instructions "as usual", consisting of multimedia content (i.e., videos of the educational/rehabilitation activities) delivered asynchronously via telemedicine platfom. The treatment will last 5 weeks with a frequency of three sessions a week.

Group Type PLACEBO_COMPARATOR

Home-based training program

Intervention Type DEVICE

Subjects will view videos on Tablet. The treatment will be provided via a digital medicine platform on a mobile device (tablet).

Interventions

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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.

Intervention Type 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).

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astir S.r.l.

UNKNOWN

Sponsor Role collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesca Baglio

Role: PRINCIPAL_INVESTIGATOR

IRCCS Fondazione Don Carlo Gnocchi ONLUS

Locations

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IRCCS Fondazione Don Carlo Gnocchi ONLUS

Milan, , Italy

Site Status

Countries

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Italy

Central Contacts

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Francesca Baglio

Role: CONTACT

+390240308952

Federica Rossetto

Role: CONTACT

Facility Contacts

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Francesca Baglio

Role: primary

+390240308952

Related Links

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Other Identifiers

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TRUST_ME

Identifier Type: -

Identifier Source: org_study_id

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