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Набор скоро начнётся NCT06724861

Sensory Rehabilitation in Chemo Induced Peripheral Neuropathy

Без фазы С лечением CIPN - Chemotherapy-Induced Peripheral Neuropathy Age Over 18 Chemotherapy-induced Peripheral Neuropathy

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: Explicit Sensory Retraining for the lower extremities, no treatment.
Кому может быть актуально
Состояния в реестре: CIPN - Chemotherapy-Induced Peripheral Neuropathy, Age Over 18, Chemotherapy-induced Peripheral Neuropathy. 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
Израиль
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Sensory Rehabilitation in CIPN

Обзор

This study is a cross-over RCT evaluating the effectiveness of 3 sessions a week apart of explicit sensory retraining to the lower extremities in individuals with CIPN versus usual care. The primary outcome measures are TNAS for subjective symptoms, VAS for pain and TUG for mobility. Additional outcome measures are FABS for balance, sensory assessments - monofilaments for touch threshold, LEPT for proprioception, a home exercise log and a satisfaction questionnaire.

Подробное описание

Chemotherapy Induced Peripheral Neuropathy (CIPN) is a neurological complication of chemotherapy, affecting between 50%-90% of the patients: up to 68% within the first month after chemotherapy, 60% after 3 months, and 30% after 6 months.

Neuropathic symptoms can persist in 11% to more than 80% of individuals post chemotherapy at one to three years following treatment and around 50% even after 5 years and more.

CIPN is associated with lower self-reported physical function and Quality of Life (QoL).

The clinical picture is typically sensory, with involvement of large and small sensory fibers. Motor and autonomic involvement is less frequent.

Damage to sensory nerve fibers is typically symmetrical. Sensory loss in a 'glove and stocking type' distribution leads to 'minus' symptoms (loss of function) including numbness in hands and feet, impaired perception of light touch, hypoalgesia and impaired proprioception, temperature and vibration sensation. Paradoxically, 'plus' features (gain of function) such as paresthesia (tingling like pins and needles), dysesthesia, allodynia and hyperalgesia appear simultaneously. CIPN can be functionally debilitating including impaired balance, walking slower and shorter steps and increased falls.

Active, explicit sensory rehabilitation is efficient in promoting sensation and function in individuals with neurological conditions, such as stroke and multiple sclerosis. To the best of our knowledge although CIPN is primarily a sensory deficit there is no treatment aimed at this aspect. We aim to conduct a pilot study to explore the feasibility and clinical benefit of an active, explicit sensory rehabilitation protocol for the lower limb in individuals with chronic CIPN.

This study is a cross-over RCT evaluating the effectiveness of 3 sessions a week apart of explicit sensory retraining to the lower extremities in individuals with CIPN versus usual care. The primary outcome measures are TNAS for subjective symptoms, VAS for pain and TUG for mobility. Additional outcome measures are FABS for balance, sensory assessments - monofilaments for touch threshold, LEPT for proprioception, a home exercise log and a satisfaction questionnaire.

Вмешательства

  • Другое Explicit Sensory Retraining for the lower extremities
    Sensory retraining of detection, discrimination, quantification of a stimuli and recognition of stimuli and objects with the leg and mainly with the foot. Top-down awareness of bottom-up sensory experience in the treatment session and in everyday life.
  • Другое no treatment
    Usual care

Первичные конечные точки

  • Patient self-Report Outcome Measure - Treatment-Induced Neuropathy Assessment Scale (TNAS) [Срок оценки: from randomization 3 months maximum]
  • Functional - Balance and mobility outcome measure - Timed Up and Go test (TUG) [Срок оценки: from randomization to maximum 3 months followup]
  • Pain intensity: VAS - 0-100 mm visual scale [Срок оценки: from randomization to maximum 3 months]
Вторичные конечные точки (3)
  • Tactile function assessment - Semmes Weinstein Monofilaments (SWM) [Срок оценки: from randomization to maximum 3 months followup]
  • FABS - Fullerton Advanced Balance Scale [Срок оценки: from randomization to maximum 3 months]
  • Proprioception of lower extremity: Lower Extremity Position Test (LEPT) [Срок оценки: from randomization to maximum 3 months followup]

Критерии участия

Критерии включения

  • CIPN by self-report (present or absent) > 3 months after last chemotherapy treatment
  • age > 18.

Критерии исключения

  • Pre-chemotherapy neuropathy/ sensory impairment
  • recurrent falls prior to chemotherapy (more than 2 per year)
  • CNS involvement
  • not ambulatory before chemotherapy
  • Hebrew proficiency not meeting questionnaires' needs.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Израиль · 1 центр
  • Asaph-Harofe Shamir Medical Center — Rishon LeZiyyon

Идентификаторы

NCT: NCT06724861 · CIPN - RCT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗