- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07854574
Effect of Immersive Virtual Reality on Postural Control and Risk of Fall in Patients With Chemotherapy-Induced Peripheral Neuropathy
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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mariam Motie Elfouly
- Número de teléfono: 201060416864
- Correo electrónico: mariammotie@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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).
Otros nombres:
|
|
Experimental: 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).
Otros nombres:
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall stability Index (OSI) by The Biodex balance system (BBS)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anterior-posterior stability index (APSI) by the biodex balance system
Periodo de tiempo: Baseline to 6 week post intervention
|
|
Baseline to 6 week post intervention
|
|
The mediolateral stability index (MLSI) by the biodex balance system
Periodo de tiempo: Baseline to 6 weeks post intervention
|
|
Baseline to 6 weeks post intervention
|
|
Fall Risk Index (FRI) by the biodex balance system
Periodo de tiempo: 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
Periodo de tiempo: Baseline to 6 weeks post intervention
|
The modified clinical test of sensory integration and balance (MCTSIB):-
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)
Periodo de tiempo: Baseline to 6 weeks post intervention
|
|
Baseline to 6 weeks post intervention
|
|
The Berg Balance Scale
Periodo de tiempo: Baseline to 6 weeks post intervention
|
The Berg Balance Scale
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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- IMMERSIVE VR in CIPN
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .