Telerehabilitation in Central and Peripheral Neurological Sequelae From Chemotherapy

NCT07159854 | Not Yet Recruiting

• 1 other identifier: TRUST_ME
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chemotherapy-induced neurotoxicity; rehabilitation; telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Changes in Activation level of Patients measured by Patient Activation Measure 13 (PAM13; Hibbard et al., 2004)

  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.

  Time Frame: Baseline, post-treatment (up to 5 weeks)

Secondary Outcomes (9)

• Change in Functional Assessment of Cancer Therapy-Cognitive Function - FACT-Cog (Fardell et al., 2022. 10.1002/pon.5928);

  Baseline, post-treatment (up to 5 weeks)

• Change in EORTC CIPN-20 questionnaire (Postam et al., 2005).

  Baseline, post-treatment (up to 5 weeks)

• Change in Patient Health Engagement Scale (PHE) (Graffigna et al., 2017)

  Baseline, post-treatment (up to 5 weeks)

• Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment (MoCA; Santangelo et al., 2015)

  Baseline, post-treatment (up to 5 weeks)

• Change in visuoperceptual and attentional abilities measured by Trail Making Test (TMT part-A and part-B; Giovagnoli et al., 1996)

  Baseline, post-treatment (up to 5 weeks)

Other Outcomes (8)

• Changes in brain morphometry as detected by Magnetic Resonance Imaging Examination.

  Baseline, post-treatment (up to 5 weeks)

• Changes in structural connectivity as detected by Magnetic Resonance Imaging Examination.

  Baseline, post-treatment (up to 5 weeks)

• Changes in functional connectivity as detected by Magnetic Resonance Imaging Examination.

  Baseline, post-treatment (up to 5 weeks)

Study Arms (2)

TRUST_ME

EXPERIMENTAL

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).

Device: RICORDO-DTx system; Device: HOMING system

Treatment as Usual

PLACEBO COMPARATOR

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.

Device: Home-based training program

Interventions

RICORDO-DTx system 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.

TRUST_ME

HOMING system 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).

TRUST_ME

Home-based training program DEVICE

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

Treatment as Usual

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Astir S.r.l.: collaborator

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi ONLUS

Milan, 20148, Italy

Location

Related Links

• internet page of Institution
• internet page of Research Unit

Study Officials

• Francesca Baglio

  IRCCS Fondazione Don Carlo Gnocchi ONLUS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Baglio

CONTACT

+390240308952; fbaglio@dongnocchi.it

Federica Rossetto

CONTACT

frossetto@dongnocchi.it

Study Design

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

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)