Whole-Body Vibration on Balance, Risk of Falling and Quality of Life in Chemotherapy-Induced Peripheral Neuropathy

Официальное название

Effect of Whole Body Vibration on Balance, Risk of Falling, and Quality of Life in Patients With Chemotherapy Induced Peripheral Neuropathy

Обзор

The goal of this clinical trial is to evaluate the efficacy of Whole-body vibration in improving postural control, risk of falling, and quality of life in patients with chemotherapy-induced peripheral neuropathy. The main questions it aims to answer are: Does Whole-body vibration have a significant effect on postural control, risk of falling, and quality of life in patients with chemotherapy-induced peripheral neuropathy? Researchers will compare whole body vibration in addition to traditional exercise to traditional exercise alone to see if Whole-body vibration have a significant effect on postural control, risk of falling, and quality of life in patients with chemotherapy-induced peripheral neuropathy. Participants will: * age between 30-60 years old. * be on chemotherapy for at least one cycle as a treatment of malignant tumors with peripheral neuropathy. * have mild to moderate neuropathy according to mTNS. * be assigned randomly into two equal groups (control group (A) and study group (B)). * Take three sessions per week for eight weeks. * The control group (A) will be treated by selected physical therapy treatment (Strength resistive training, Stretching \& flexibility, Balance training) * The study group (B) will be treated with selected physical therapy treatment in addition to whole-body vibration therapy.

Подробное описание

Chemotherapy-induced peripheral neuropathy (CIPN) is a persistent cancer treatment-related side effect that negatively impacts physical functioning, falls, and quality of life. CIPN may lead to muscle weakness, loss of ankle reflexes, and impairment in balance, coordination, and gait control, which significantly increase the risk of falling and sustaining fall-related injuries. Risk of fall in cancer patients occur due to multimodal causes that occur either due to cancer itself or anti- cancer drugs, some of the side-effects that may have the upper hand in increasing risk of fall are sarcopenia, chemotherapy induced peripheral neuropathy, decrease in exercise capacity and muscle strength, decrease balance function, and physical frailty. For cancer survivors, falling and the combined effects of these risk factors have a detrimental influence on felt well-being and a substantial potential reduction in quality of life. Falls also impose significant burdens psychologically (e.g., developing anxiety and fear of falling) and economically (e.g., incurring large medical costs). Furthermore, the loss of independence following a fall and the fear of falling again can have a negative impact on a patient's quality of life. Whole-body vibration emerged as an alternative to improve neuromuscular functions and fall risk in the physical therapy field. The transmission of such mechanical vibrations to the human body causes the tonic vibration reflex (TVR), a complex spinal and supraspinal neurophysiological reaction. The TVR increases muscle activation and improves functional performance.It causes the motor units to be activated, which results in neuromuscular facilitation. This improves the patient's total functional activity and their static and dynamic balance. All these consequences are equivalent to engaging in any cumbersome exercise or difficult activity, which is impractical for these people.

This study aims to investigate the effect of Whole-body vibration on postural control, risk of falling and quality of life in patients with chemotherapy-induced peripheral neuropathy.

Thirty patients from both sexes were diagnosed with cancer and chemotherapy-induced peripheral neuropathy. They will be selected from centre of Clinical Oncology and Nuclear Medicine at El-Kasr Al-Aini Hospitals.Their ages will range from 30 to 60 years old. All patients who will be included will be on chemotherapy for at least one cycle as a treatment of malignant tumors with peripheral neuropathy. The patients will have mild to moderate neuropathy according to mTNS. All Patients should understand verbal instructions and follow the instructor. The selected patients will be assigned randomly into two equal groups (control group (A) and study group (B)).

Вмешательства

• Устройство Whole Body Vibration
  15 min of Whole-body vibration therapy 3 sessions per week for 8 weeks, as follow: 24 * Duration: about 15 minutes per session * Vibration Frequency: 18-40 Hz (starting at lower frequency and progressing) * Position: Standing on the platform with slight knee flexion to activate muscles, progressing to squats and dynamic movements over time. The patient may start standing. * Progression Plan: * Weeks 1-2: Low frequency (18-25 Hz) for short intervals * Weeks 3-5: Increase frequency to (25-35 Hz)
• Другое Traditional exercise
  -Strength resistive training: Core strengthening, Squat \& set up, sit to stand exercise, calf raises \& squats, Seated leg ex, Straight leg raising exercise, clamshell, Dorsi flexion exercise, Quad set -Stretching \& flexibility: Stretch for lower limb (Hamstring, Calf) \- Balance training: Single leg stance (Stable surface then unstable one), Gait training with obstacles \& alternating speed \& different directions (side steps, steps over cones), Balane board.

Первичные конечные точки

• Risk of fall [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Quality of life (QOL) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Balance [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (1)

• Functional mobility [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• 30 patients diagnosed with chemotherapy-induced peripheral neuropathy from both genders.
• Their ages will range from 30-60 years old.
• All patients included in this study will be on chemotherapy from at least one cycle as a treatment of malignant tumor.
• The patients will be mild to moderate neuropathy according to mTNS.
• They were medically stable.

Критерии исключения

• History of other types of neuropathies (i.e., hereditry peripheral neuropathy associated with nutritional agents and paraneoplastic syndrome-related neuropathy…etc).
• Unstable medical condition during chemotherapy
• Patients who are starting new therapy or dose modification during study period
• Morbid obesity body mass index >40%
• History of non-surgically repaired nerve compression injuries such as carpal tunnel, brachial plexopathy, spinal stenosis, and spinal nerve root compression
• History of central nervous system primary or metastatic malignancy.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07508527 · P.T.REC/012/005790

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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