- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07568821
Effectiveness of VR Rehabilitation for People With Asymmetrical Gait Patterns
Evaluation of the Effectiveness of Rehabilitation in Patients With Gait Pattern Asymmetry Using a Virtual Reality
A randomized comparative study will be conducted to evaluate the rehabilitation process using a VR-based application versus conventional therapy in 40 patients (sample size determined using a sample size calculator). After meeting the eligibility criteria, participants will be randomly assigned to two groups: the experimental group (20 patients with gait pattern asymmetry), performing a gait training program using a VR rehabilitation application, and the control group (20 patients with gait pattern asymmetry), performing only a conventional gait training program.
Participants in both groups will take part in a 2-week rehabilitation program (Monday to Friday), with daily training sessions lasting up to 2 hours. Patient assessment will be conducted twice: an initial evaluation before the start of the intervention (Assessment I) and a follow-up evaluation after completion of the 2-week program (Assessment II), at the same time of day, under the same conditions, and using the same measurement tools.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Individuals with a diagnosed and clinically confirmed asymmetry of gait pattern will be eligible for inclusion in the study.
Exclusion criteria: Active rheumatic diseases, cancer, advanced diabetes, cardiovascular diseases, and other conditions affecting the safety and effectiveness of rehabilitation, Contraindications to VR therapy (epilepsy, motion sickness, dizziness, nausea), Lower limb injuries or surgeries within the last 6 months, Severe mental disorders preventing understanding of instructions.
Training for both groups will include balance and coordination exercises, proprioceptive stimulation, and exercises aimed at improving step length symmetry and lower limb loading. Additionally, the experimental group will receive 15 to 30 minutes (adjusted to the patient's abilities) of training using a VR application in a virtual environment, providing real-time feedback on body position, step length, and balance. The effects of gait training will be evaluated using the following measures: gait speed, walking endurance, independent mobility and risk of falls, balance, gait symmetry, spinal mobility, and functional performance.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Agnieszka Guzik
- Número de teléfono: +48 17 851 8965
- Correo electrónico: aguzik@ur.edu.pl
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Diagnosed and clinically confirmed gait pattern asymmetry in the course of neurological diseases
- Informed consent to participate in the study and willingness to comply with rehabilitation recommendations
Exclusion Criteria:
- Active rheumatic diseases, cancer, advanced diabetes, cardiovascular diseases, and other conditions that may affect the safety and effectiveness of rehabilitation
- Contraindications to VR therapy (epilepsy, motion sickness, dizziness, nausea)
- Lower limb injuries or surgeries within the last 6 months
- Severe mental disorders preventing understanding of instructions
- Lack of informed consent to participate in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Control: Rehabilitación Estándar
|
The control group will participate only in a conventional gait training program.
Participants will take part in a 2-week rehabilitation program (Monday to Friday), with daily training sessions lasting up to 2 hours.
Training will include balance and coordination exercises, proprioceptive stimulation, and exercises aimed at improving step length symmetry and lower limb loading.
|
|
Experimental: VR Therapy and Standard Rehabilitation
|
The experimental group will participate in a gait training program using a VR rehabilitation application.
Participants will take part in a 2-week rehabilitation program (Monday to Friday), with daily training sessions lasting up to 2 hours.
Training will include balance and coordination exercises, proprioceptive stimulation, and exercises aimed at improving step length symmetry and lower limb loading.
Additionally, the experimental group will receive 15 to 30 minutes (adjusted to the patient's abilities) of training using a VR application in a virtual environment, providing real-time feedback on body position, step length, and balance.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Gait speed - 10-meter walk test
Periodo de tiempo: Baseline (Day 1)
|
Baseline (Day 1)
|
|
Gait speed - 10-meter walk test
Periodo de tiempo: Immediately after therapy completion (Day 10)
|
Immediately after therapy completion (Day 10)
|
|
Walking Endurance - 6-Minute Walk Test
Periodo de tiempo: Baseline (Day 1)
|
Baseline (Day 1)
|
|
Walking Endurance - 6-Minute Walk Test
Periodo de tiempo: Immediately after therapy completion (Day 10)
|
Immediately after therapy completion (Day 10)
|
|
Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
Periodo de tiempo: Baseline (Day 1)
|
Baseline (Day 1)
|
|
Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
Periodo de tiempo: Immediately after therapy completion (Day 10)
|
Immediately after therapy completion (Day 10)
|
|
Lower Limb Loading Symmetry - Two-Scale Test
Periodo de tiempo: Baseline (Day 1)
|
Baseline (Day 1)
|
|
Lower Limb Loading Symmetry - Two-Scale Test
Periodo de tiempo: Immediately after therapy completion (Day 10)
|
Immediately after therapy completion (Day 10)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Gait and Balance - Dynamic Gait Index
Periodo de tiempo: Baseline (Day 1)
|
Baseline (Day 1)
|
|
|
Gait and Balance - Dynamic Gait Index
Periodo de tiempo: Immediately after therapy completion (Day 10)
|
Immediately after therapy completion (Day 10)
|
|
|
Gait Asymmetry - Wisconsin Gait Scale
Periodo de tiempo: Baseline (Day 1)
|
The Wisconsin Gait Scale is an observational tool used to assess gait quality.
Scores range from 13.35 to 42, with higher scores indicating worse gait performance.
|
Baseline (Day 1)
|
|
Gait Asymmetry - Wisconsin Gait Scale
Periodo de tiempo: Immediately after therapy completion (Day 10)
|
The Wisconsin Gait Scale is an observational tool used to assess gait quality.
Scores range from 13.35 to 42, with higher scores indicating worse gait performance.
|
Immediately after therapy completion (Day 10)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Agnieszka Guzik, Rzeszów, Al. Rejtana 16C, Poland 35-310
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
- 1/11/2025
Información sobre medicamentos y dispositivos, documentos del estudio
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