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

2026年10月1日 更新者:Mariam Motie Elsayed Elfouly、Cairo University

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.

研究概览

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 45年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • 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.
  • Patient with mild to moderate balance impairment Berg Balance Scale ( Score ranging from 21 to 56)
  • Patient with normal cognition ( Mini-Mental scale examination score of > 24 ).
  • Ambulant patients
  • Medically stable to participate In rehabilitation.

Exclusion Criteria:

Patient will be excluded if they have one of the following:-

  • 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
  • Diabetes mellitus

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Conventional physical Therapy Exercise

Participants will receive 18 sessions over 6 weeks, 3 sessions per week. Each 60-minute session will consist of conventional physical therapy only.The intervention will consist of conventional physical exercise( static balance exercise, dynamic balance exercise, proprioceptive training, and functional mobility training).

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

其他名称:
  • Static and dynamic balance exercise
实验性的:Conventional physical Therapy Exercise + immersive VR

Participants will receive 18 sessions over 6 weeks, 3 sessions per week. Each 60-minute session will consist of 30 minutes of immersive virtual reality-based exercise and 30 minutes of conventional physical therapy.The Immersive VR training which include Game-like interactive exercise. participant should hold two controllers. Game requires continuous anticipatory postural adjustments, frequentWeight shifting (left/right), trunk rotation, and mini squats which improve dynamic balance, reaction time, sensorimotor integration (visual + vestibular + proprioception), and postural muscle activation.

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

其他名称:
  • Static and dynamic balance exercise

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.

其他名称:
  • 沉浸式VR

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Overall stability Index (OSI) by The Biodex balance system (BBS)
大体时间:Baseline to 6 week post intervention

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.

Baseline to 6 week post intervention

次要结果测量

结果测量
措施说明
大体时间
Anterior-posterior stability index (APSI) by the biodex balance system
大体时间:Baseline to 6 week post intervention
  • 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)
Baseline to 6 week post intervention
The mediolateral stability index (MLSI) by the biodex balance system
大体时间:Baseline to 6 weeks post intervention
  • 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).
Baseline to 6 weeks post intervention
Fall Risk Index (FRI) by the biodex balance system
大体时间:Baseline to 6 weeks post intervention

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.

Baseline to 6 weeks post intervention
sensory integration by the Biodex balance system
大体时间:Baseline to 6 weeks post intervention

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.

Baseline to 6 weeks post intervention
Timed Up and Go (TUG)
大体时间:Baseline to 6 weeks post intervention
  • Participant is asked to stand up from a chair, walk three meters, turn, walk back, and sit down, while the time taken is recorded.
  • A cut-off score of 13.5 seconds in the Timed Up and Go (TUG) test is commonly used, where a time exceeding this value indicates an increased risk of falls.
Baseline to 6 weeks post intervention
The Berg Balance Scale
大体时间:Baseline to 6 weeks post intervention

The Berg Balance Scale

  • patient is asked to perform tasks such as sitting unsupported, standing with eyes closed, reaching forward, turning, and transferring between positions.
  • Each task is scored on a 5-point ordinal scale (0-4) based on the patient's ability to complete the task independently, the time taken, and the level of assistance required. The total score ranges from 0 to 56.

Scores ranging from 41 to 56 indicate low fall risk and generally reflect independent mobility, while scores between 21 and 40 suggest a moderate fall risk with noticeable balance impairments and a potential need for assistance during activities. Scores from 0 to 20 represent a high fall risk and are associated with severe balance deficits and a high level of dependence.

Baseline to 6 weeks post intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年10月1日

研究注册日期

首次提交

2026年9月27日

首先提交符合 QC 标准的

2026年9月27日

首次发布 (实际的)

2026年10月2日

研究记录更新

最后更新发布 (实际的)

2026年10月5日

上次提交的符合 QC 标准的更新

2026年10月1日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • IMMERSIVE VR in CIPN

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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