Telerehabilitation in Central and Peripheral Neurological Sequelae From Chemotherapy (TRUST_ME)

Don Carlo Gnocchi Onlus Foundation

Status: Not yet enrolling

Conditions: Chemotherapy-induced Neurotoxicity

Treatments: Device: Home-based training program; Device: RICORDO-DTx system; Device: HOMING system

Study type: Interventional

Funder types: Other

Identifiers

NCT07159854

TRUST_ME

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

TRUST_ME

Experimental group

Description:

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).

Treatment:

Device: HOMING system

Device: RICORDO-DTx system

Treatment as Usual

Placebo Comparator group

Description:

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.

Treatment:

Device: Home-based training program