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Набор скоро начнётся NCT07159854

Telerehabilitation in Central and Peripheral Neurological Sequelae From Chemotherapy

Без фазы С лечением Chemotherapy-induced Neurotoxicity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: RICORDO-DTx system, HOMING system, Home-based training program.
Кому может быть актуально
Состояния в реестре: Chemotherapy-induced Neurotoxicity. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Устройство 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.
  • Устройство 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).
  • Устройство 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).

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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;

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Италия · 1 центр
  • IRCCS Fondazione Don Carlo Gnocchi ONLUS — Milan

Идентификаторы

NCT: NCT07159854 · TRUST_ME

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗