NCT07854574

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Nov 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

September 27, 2026

Last Update Submit

September 27, 2026

Conditions

Outcome Measures

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.

    Baseline to 6 week post intervention

Secondary Outcomes (6)

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

    Baseline to 6 week post intervention

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

    Baseline to 6 weeks post intervention

  • Fall Risk Index (FRI) by the biodex balance system

    Baseline to 6 weeks post intervention

  • sensory integration by the Biodex balance system

    Baseline to 6 weeks post intervention

  • Timed Up and Go (TUG)

    Baseline to 6 weeks post intervention

  • +1 more secondary outcomes

Study Arms (2)

Conventional physical Therapy Exercise

ACTIVE COMPARATOR

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).

Behavioral: The intervention will consist of conventional physical therapy exercise

Conventional physical Therapy Exercise + immersive VR

EXPERIMENTAL

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.

Behavioral: The intervention will consist of conventional physical therapy exerciseBehavioral: Immersive Virtual Reality

Interventions

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

Also known as: Static and dynamic balance exercise
Conventional physical Therapy ExerciseConventional physical Therapy Exercise + immersive VR

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.

Also known as: Immersive VR
Conventional physical Therapy Exercise + immersive VR

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Mariam Motie Elfouly

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's candidate

Study Record Dates

First Submitted

September 27, 2026

First Posted

October 2, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

October 2, 2026

Record last verified: 2026-09