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Whole Body VibrationWBV/QOL/CIPNNCT07508527

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

A study testing Whole Body Vibration and Traditional exercise in people with Whole Body Vibration and Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Cairo University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 60 years
What is being tested?
Whole Body Vibration and Traditional exercise
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Apr 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Bothina Sayed Mohamed Sayed, Bachelor's Degree contact

01016108245 ext. 01143077366

1300153@st.pt.cu.edu.eg

About this study

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

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?

Read more

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.
Read the 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)).

Being tested
Whole Body Vibration, Traditional exercise
Keywords
WBV, Whole body vibration, CIPN, Chemotherapy induced peripheral neuropathy, Balance, Risk of fall, falling, postural control, fall, QOL, Quality of life

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole Body VibrationDevice

    Also called Whole-Body Vibration, WBV

    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).
  • Traditional exerciseOther

    -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.
Study groups in NCT07508527
Study groupRoleWhat they receive
Control Group (Group A)Active comparatorGroup 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.
Receives: Other: Traditional exercise
Study Group (Group B)ExperimentalGroup 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).
Receives: Device: Whole Body Vibration; Other: Traditional exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to the end of treatment at 8 weeks

  2. 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):
    2. Physical Well-being (PWB) (7 items).
    3. Social/Family Well-being (SWB) (7 items) .
    4. Emotional Well-being (EWB) (6 items).
    5. Functional Well-being (FWB) (7 items).
    6. 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.

    Measured: From enrollment to the end of treatment at 8 weeks

  3. 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

    Measured: From enrollment to the end of treatment at 8 weeks

Secondary outcomes (1)
  1. 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:

    1. Stand up from a standard chair (seat height ~46 cm).
    2. Walk 3 meters (10 feet) at a comfortable pace.
    3. Turn around 180 degrees.
    4. Walk back to the chair.
    5. Sit down again. The entire test is timed in seconds, with shorter times indicating better functional mobility.
    • Scoring:
    1. < 10 sec → Normal mobility.
    2. 11-20 sec → Normal for elderly or disabled individuals but indicates some mobility challenges.
    3. 20 sec → Increased fall risk and functional impairment, i.e. poor mobility or might be due to poor mentality.
    4. 30 sec → High fall risk and significant mobility impairment.

    Measured: From enrollment to the end of treatment at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trail
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07508527
Sponsor's protocol ID
P.T.REC/012/005790
Acronym
WBV/QOL/CIPN
Status last verified
Mar 2026
First submitted
16 Mar 2026
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Whole Body Vibration and Traditional exercise in people with Whole Body Vibration and Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Cairo University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bothina Sayed Mohamed Sayed, Bachelor's Degree (01016108245 ext. 01143077366, 1300153@st.pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risk of fall (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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