Whole-Body Vibration on Balance, Risk of Falling and Qual... | NCT07508527

Status Module

Description Module

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)).

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group (Group A)	Active Comparator	Group A (Control Group): Patients will receive selected physical therapy treatment, 3 sessions per week for 8 weeks. The session will contain: Strength resistance 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.	Other: Traditional exercise
Study Group (Group B)	Experimental	Group B (Study Group): Patients will receive the same selected physical therapy as in group (A) in addition to 15 min of Whole-body vibration therapy 3 sessions per week for 8 weeks, as follow: 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) with longer intervals Weeks 6-8: Progress to higher frequency (35-40 Hz) with the introduction of additional balance exercises while on the platform (e.g., squats, heel raises).	Device: Whole Body Vibration Other: Traditional exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Whole Body Vibration	Device	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) with longer intervals Weeks 6-8: Progress to higher frequency (35-40 Hz) with the introduction of additional balance exercises while on the platform (e.g., squats, heel raises).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Risk of fall	It will be measured by Falls Efficacy Scale International (FES-I): FES-I consists of 16 items, each rated on a 4-point Likert scale: = Not at all concerned = Somewhat concerned = Fairly concerned = Very concerned Scoring and Interpretation: Minimum score = 16 (no concern about falling). Maximum score = 64 (high concern about falling). 16-19 → Low concern about falling. 20-27 → Moderate concern. 28-64 → High concern, associated with increased fall risk and activity avoidance.	From enrollment to the end of treatment at 8 weeks
Quality of life (QOL)	The FACT-GOG-NTX is a combination of the FACT-G (core cancer QoL questionnaire, 27 items) and a specific neurotoxicity subscale (NTX, 11 items). FACT-G (27 items, Core QoL Measure): Physical Well-being (PWB) (7 items). Social/Family Well-being (SWB) (7 items) . Emotional Well-being (EWB) (6 items). Functional Well-being (FWB) (7 items). NTX Subscale (11 items, Chemotherapy-Induced Neuropathy Symptoms) Sensory Symptoms Motor Symptoms . Autonomic Symptoms. Interference with Daily Activities. Scoring of the FACT-GOG-NTX: Items are rated on a 5-point Likert scale: 0 = Not at all = A little bit = Somewhat = Quite a bit = Very much Higher scores in the FACT-G core scales = Better QoL. Higher NTX subscale scores = Worse neurotoxicity symptoms.	From enrollment to the end of treatment at 8 weeks
Balance	It will be measured by Berg Balance Scale (BBS) Berg Balance Scale(BBS): BBS consists of 14 functional tasks, each scored on a five-point ordinal scale (0-4), with a maximum total score of 56. Higher scores indicate better balance and a lower risk of falls.(Muir et al., 2008) Appendix III The tasks include: Static balance tasks (e.g., standing unsupported, sitting balance) Dynamic balance tasks (e.g., reaching forward, turning 360°, standing on one leg) Transfers and weight shifts (e.g., sit-to-stand, standing with eyes closed) Scores for Fall Risk: 0-20: High fall risk 21-40: Moderate fall risk 41-56: Low fall risk	From enrollment to the end of treatment at 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Functional mobility	It will be measured by Time Up & Go test (TUG) The Timed Up and Go (TUG) test is a widely used functional mobility and fall risk assessment tool. The test measures the time (in seconds) it takes for a person to: Stand up from a standard chair (seat height ~46 cm). Walk 3 meters (10 feet) at a comfortable pace. Turn around 180 degrees. Walk back to the chair. Sit down again. The entire test is timed in seconds, with shorter times indicating better functional mobility. Scoring: < 10 sec → Normal mobility. 11-20 sec → Normal for elderly or disabled individuals but indicates some mobility challenges. 20 sec → Increased fall risk and functional impairment, i.e. poor mobility or might be due to poor mentality. 30 sec → High fall risk and significant mobility impairment.

Eligibility Module

Name	Affiliation	Role
Bothina Sayed Mohamed, Bachelor's Degree	Physical Therapist at Department of clinical oncology and nuclear medicine, Cairo university Hospitals (Kasr El-Einy); Bachelor's Degree from Faculty of Physical Therapy, Cairo University	Principal Investigator
Mohamed Abd El-Rahman Hassan, Professor of Clinical Oncology	Professor of Clinical Oncology, Department of clinical oncology and nuclear medicine, Faculty of Medicine, Kasr El-Einy, Cairo University.