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

1 octobre 2026 mis à jour par: 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.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

30 ans à 45 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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).

Autres noms:
  • Static and dynamic balance exercise
Expérimental: 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).

Autres noms:
  • 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.

Autres noms:
  • Réalité virtuelle immersive

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Overall stability Index (OSI) by The Biodex balance system (BBS)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Anterior-posterior stability index (APSI) by the biodex balance system
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

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Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 novembre 2026

Achèvement primaire (Estimé)

1 août 2027

Achèvement de l'étude (Estimé)

1 octobre 2027

Dates d'inscription aux études

Première soumission

27 septembre 2026

Première soumission répondant aux critères de contrôle qualité

27 septembre 2026

Première publication (Réel)

2 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • IMMERSIVE VR in CIPN

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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