Effect of Immersive Virtual Reality on Postural Control and Risk of Fall in Patients With Chemotherapy-Induced Peripheral Neuropathy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-45
SponsorCairo University

About this trial

Chemotherapy-induced peripheral neuropathy (CIPN) is a major cause of functional disability in cancer survivors. Patients with CIPN typically present with numbness, tingling, burning pain, and loss of proprioception, particularly in distal extremities. The sensory and motor deficits associated with CIPN impair balance and increase the likelihood of falls, which may lead to injury, decreased independence, and reduced quality of life. Loss of proprioception and vibration sense in CIPN disrupts sensory integration required for maintaining postural control. Consequently, individuals with CIPN often demonstrate gait instability, impaired balance, and increased sway during standing and walking tasks. Recent evidence suggests that immersive VR rehabilitation is feasible and safe for individuals with moderate to severe CIPN. Additionally, VR-based interventions may improve sensory symptoms and postural stability without adverse effects. Studies have demonstrated that immersive VR training improves the integration of visual and proprioceptive information, leading to enhanced postural stability in individuals with balance impairments. Virtual reality technology has shown promising results in balance rehabilitation by providing interactive environments that enhance patient engagement and stimulate multisensory feedback mechanisms. So, the purpose of the current study is to investigate the effect of immersive virtual reality on postural control and risk of fall in patients with chemotherapy-induced peripheral neuropathy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Forty female patients with chronic chemotherapy-induced peripheral neuropathy.

Duration of illness will be from 3 months to 1 year after completion of chemotherapy.

The patients age will be from 30 to 45.

BMI will be ranged from 25-29.9 kg/m2.

Disqualifiers

Neurological Disorders affecting postural control and risk of fall other than CIPN (Diabetic polyneuropathy, Multiple sclerosis , and Radiculopathy)

Any musculoskeletal disorders affecting balance ( Scoliosis, kyphosis, and fracture)

Vestibular disorders and Visual impairments affecting balance.

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • The intervention will consist of conventional physical therapy exercise

    Behavioral

    ( static balance exercise, dynamic balance exercise, proprioceptive training, and functional mobility training).

  • Immersive Virtual Reality

    Behavioral

    Immersive virtual reality (IVR) uses head-mounted displays to place users inside interactive, 3D digital environments that actively train human postural control.VR-based interventions may improve sensory symptoms and postural stability without adverse effects. Studies have demonstrated that immersive VR training improves the integration of visual and proprioceptive information, leading to enhanced postural stability in individuals with balance impairments. Virtual reality technology has shown promising results in balance rehabilitation by providing interactive environments that enhance patient engagement and stimulate multisensory feedback mechanisms.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Conventional physical Therapy ExerciseActive comparator 1 intervention
Group B: Conventional physical Therapy Exercise + immersive VRExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall stability Index (OSI) by The Biodex balance system (BBS)

The test is commonly performed under both static and dynamic conditions, with the platform stability level adjusted (e.g., levels 8 to 1, where lower levels indicate greater instability). Patients are instructed to maintain their center of gravity within the target displayed on the screen while minimizing platform movement. Each trial usually lasts 20-30 seconds and is repeated 2-3 times, with rest intervals between trials to avoid fatigue. The Biodex system automatically calculates the stability indices based on the degree of platform tilt in different directions: the OSI reflects overall variance of platform displacement.

Time frame
Baseline to 6 week post intervention

Secondary outcomes

1

Anterior-posterior stability index (APSI) by the biodex balance system

* Patients are instructed to maintain their center of gravity within the target displayed on the screen while minimizing platform movement. Each trial usually lasts 20-30 seconds and is repeated 2-3 times, with rest intervals between trials to avoid fatigue. * The Biodex system automatically calculates the stability indices based on the degree of platform tilt in different directions: the APSI represents sway in the sagittal plane (forward-backward)

Time frame
Baseline to 6 week post intervention
2

The mediolateral stability index (MLSI) by the biodex balance system

* Patients are instructed to maintain their center of gravity within the target displayed on the screen while minimizing platform movement. Each trial usually lasts 20-30 seconds and is repeated 2-3 times, with rest intervals between trials to avoid fatigue. * The Biodex system automatically calculates the stability indices based on the degree of platform tilt in different directions: MLSI measures sway in the frontal plane (side-to-side).

Time frame
Baseline to 6 weeks post intervention
3

Fall Risk Index (FRI) by the biodex balance system

Fall Risk Index (FRI) can be automatically calculated by the biodex balance system to quantify the individual's risk of falling. Higher values indicate greater instability and increased fall risk.

Time frame
Baseline to 6 weeks post intervention
4

sensory integration by the Biodex balance system

The modified clinical test of sensory integration and balance (MCTSIB):- * Condition one: The patient stand on a firm surface with opened eyes and looked at a target on the display screen during platform tilt so incorporated visual, vestibular, and somatosensory inputs. * Condition two: The patient stood on a firm surface with closed eyes and eliminated visual input to evaluate vestibular and somatosensory inputs during platform tilt. * Condition three: The patient stood on a foam surface with opened eyes and looked at a target on the display screen during platform tilt to evaluate somatosensory interaction with visual input. * Condition four: The patient stands on a foam surface with closed eyes during platform tilt to evaluate somatosensory interaction with vestibular input. The higher the sway index,the more unsteady the person was during the test. The patient performed three trials; the trial duration was 20 seconds with a rest period of 25 seconds.

Time frame
Baseline to 6 weeks post intervention

Other outcomes

Locations

This trial has no locations.

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