CIPN - Chemotherapy-Induced Peripheral NeuropathyNCT07854574
Effect of Immersive Virtual Reality on Postural Control and Risk of Fall in Patients With Chemotherapy-Induced Peripheral Neuropathy
A study testing The intervention will consist of conventional physical therapy exercise and Immersive Virtual Reality in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women only
- Conditions the study is for
- CIPN - Chemotherapy-Induced Peripheral Neuropathy
- What is being tested?
- The intervention will consist of conventional physical therapy exercise and Immersive Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Oct 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- The intervention will consist of conventional physical therapy exercise, Immersive Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention will consist of conventional physical therapy exerciseBehavioural
Also called Static and dynamic balance exercise
( static balance exercise, dynamic balance exercise, proprioceptive training, and functional mobility training).
Immersive Virtual RealityBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: The intervention will consist of conventional physical therapy exercise; Behavioral: Immersive Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 week post intervention
Secondary outcomes (6)
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)
Measured: Baseline to 6 week post intervention
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).
Measured: Baseline to 6 weeks post intervention
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.
Measured: Baseline to 6 weeks post intervention
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.
Measured: Baseline to 6 weeks post intervention
Timed Up and Go (TUG)
- 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.
Measured: Baseline to 6 weeks post intervention
The Berg Balance Scale
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.
Measured: Baseline to 6 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIPN - Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Motie Elsayed Elfouly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854574
- Sponsor's protocol ID
- IMMERSIVE VR in CIPN
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immersive Virtual Reality on Postural Control and Risk of Fall in Patients With Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07854574
- Acronym / sponsor ID
- IMMERSIVE VR in CIPN
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional physical Therapy Exercise | Active comparator | Behavioral: The intervention will consist of conventional physical therapy exerciseParticipants 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). |
| Conventional physical Therapy Exercise + immersive VR | Experimental | Behavioral: The intervention will consist of conventional physical therapy exercise, Behavioral: Immersive Virtual RealityParticipants 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. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The intervention will consist of conventional physical therapy exerciseAlso: Static and dynamic balance exercise( static balance exercise, dynamic balance exercise, proprioceptive training, and functional mobility training). | Behavioural | Conventional physical Therapy Exercise, Conventional physical Therapy Exercise + immersive VR |
| Immersive Virtual RealityAlso: Immersive VRImmersive 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. | Behavioural | Conventional physical Therapy Exercise + immersive VR |
Primary outcome
Overall stability Index (OSI) by The Biodex balance system (BBS)
Time frame: 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.
6 secondary outcomes
Anterior-posterior stability index (APSI) by the biodex balance system
Time frame: Baseline to 6 week post intervention
The mediolateral stability index (MLSI) by the biodex balance system
Time frame: Baseline to 6 weeks post intervention
Fall Risk Index (FRI) by the biodex balance system
Time frame: Baseline to 6 weeks post intervention
sensory integration by the Biodex balance system
Time frame: Baseline to 6 weeks post intervention
Timed Up and Go (TUG)
Time frame: Baseline to 6 weeks post intervention
The Berg Balance Scale
Time frame: Baseline to 6 weeks post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention will consist of conventional physical therapy exercise and Immersive Virtual Reality in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy, 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 8 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 5 Oct 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 Mariam Motie Elfouly (201060416864, mariammotie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall stability Index (OSI) by The Biodex balance system (BBS) (time frame: Baseline to 6 week post intervention). 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 5 Oct 2026.