Menu
Not yet recruiting NCT07159854

Telerehabilitation in Central and Peripheral Neurological Sequelae From Chemotherapy

No phase Interventional Chemotherapy-induced Neurotoxicity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RICORDO-DTx system, HOMING system, Home-based training program.
Who it may be relevant to
Registry conditions: Chemotherapy-induced Neurotoxicity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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).

Primary outcome measures

  • Changes in Activation level of Patients measured by Patient Activation Measure 13 (PAM13; Hibbard et al., 2004) [Time frame: Time Frame: Baseline, post-treatment (up to 5 weeks)]
Secondary outcome measures (9)
  • Change in Functional Assessment of Cancer Therapy-Cognitive Function - FACT-Cog (Fardell et al., 2022. 10.1002/pon.5928); [Time frame: Baseline, post-treatment (up to 5 weeks)]
  • Change in EORTC CIPN-20 questionnaire (Postam et al., 2005). [Time frame: Baseline, post-treatment (up to 5 weeks)]
  • Change in Patient Health Engagement Scale (PHE) (Graffigna et al., 2017) [Time frame: Baseline, post-treatment (up to 5 weeks)]
  • Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment (MoCA; Santangelo et al., 2015) [Time frame: 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) [Time frame: Baseline, post-treatment (up to 5 weeks)]
  • Change in long term visual memory measured by Free and Cued Selective Reminding Test (FCSRT) (Frasson et al., 2011) [Time frame: Baseline, post-treatment (up to 5 weeks)]
  • Change in Static and dynamic balance measured by Mini-Best Test (Franchignoni et al., 2010) [Time frame: Baseline, post-treatment (up to 5 weeks)]
  • Change in Aerobic Capacity and Gait measured by 6' Minute Walking Test (6MWT) [Time frame: Baseline, post-treatment (up to 5 weeks)]
  • Change in strength level using a dynamometer [Time frame: Baseline, post-treatment (up to 5 weeks)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • IRCCS Fondazione Don Carlo Gnocchi ONLUS — Milan

Identifiers

NCT: NCT07159854 · TRUST_ME

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗