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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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%

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • Traditional exercise

    Other intervention

    -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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Control Group (Group A)Active comparator 1 intervention
Group B: Study Group (Group B)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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): 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.

Time frame
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

Time frame
From enrollment to the end of treatment at 8 weeks

Secondary outcomes

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.

Time frame
From enrollment to the end of treatment at 8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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