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

NCT07508527 | Not Yet Recruiting DMC

• 1 other identifier: P.T.REC/012/005790
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Whole Body Vibration; Chemotherapy Induced Peripheral Neuropathy (CIPN); Fall Risk, Fall Prevention; Balance; Quality of Life

Keywords

WBV; Whole body vibration; CIPN; Chemotherapy induced peripheral neuropathy; Balance; Risk of fall; falling; postural control; fall; QOL; Quality of life

Outcome Measures

Primary Outcomes (3)

• 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: 1. = Not at all concerned 2. = Somewhat concerned 3. = Fairly concerned 4. = 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). 1. FACT-G (27 items, Core QoL Measure): 1. Physical Well-being (PWB) (7 items). 2. Social/Family Well-being (SWB) (7 items) . 3. Emotional Well-being (EWB) (6 items). 4. Functional Well-being (FWB) (7 items). 2. 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 1. = A little bit 2. = Somewhat 3. = Quite a bit 4. = 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 (1)

• Functional mobility

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

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

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).

Also known as: Whole-Body Vibration, WBV

Study Group (Group B)

Traditional exercise OTHER

-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.

Control Group (Group A); Study Group (Group B)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Officials

• 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.

  STUDY DIRECTOR

• Nahed Ahmed Salem, Professor of Physical Therapy

  Professor of Physical Therapy for Neurology and Neurosurgery, Faculty of Physical Therapy, Cairo University

  STUDY CHAIR

• Mohamed Helayel Marzouk, Lecture of Physical Therapy

  Lecture of Physical Therapy for Neurology and Neurosurgery, Faculty of Physical Therapy, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Bothina Sayed Mohamed Sayed, Bachelor's Degree

CONTACT

01016108245; 1300153@st.pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, Physical Therapist at Cairo University Hospitals (Kasr El-Einy) Center of Radiation Oncology and Nuclear Medicine; Bachelor's Degree from Faculty of Physical Therapy, Cairo University

Model Details: Randomized Controlled Trail

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: April 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share