Whole-Body Vibration on Balance, Risk of Falling and Quality of Life in Chemotherapy-Induced Peripheral Neuropathy
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: Whole Body Vibration, Traditional exercise.
- Who it may be relevant to
- Registry conditions: Whole Body Vibration, Chemotherapy Induced Peripheral Neuropathy (CIPN), Fall Risk, Fall Prevention, Balance. Basic parameters: 30 years — 60 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Whole Body Vibration on Balance, Risk of Falling, and Quality of Life in Patients With Chemotherapy Induced Peripheral Neuropathy
Overview
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.
Detailed description
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)).
Interventions
- Device 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) - Other 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.
Primary outcome measures
- Risk of fall [Time frame: From enrollment to the end of treatment at 8 weeks]
- Quality of life (QOL) [Time frame: From enrollment to the end of treatment at 8 weeks]
- Balance [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (1)
- Functional mobility [Time frame: From enrollment to the end of treatment at 8 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
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
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07508527 · P.T.REC/012/005790