Effectiveness of VR Rehabilitation for People With Asymmetrical Gait Patterns

Официальное название

Evaluation of the Effectiveness of Rehabilitation in Patients With Gait Pattern Asymmetry Using a Virtual Reality

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Virtual Reality (VR) 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 a
• Другое Standard Rehabilitation
  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.

Первичные конечные точки

• Gait speed - 10-meter walk test [Срок оценки: Baseline (Day 1)]
• Gait speed - 10-meter walk test [Срок оценки: Immediately after therapy completion (Day 10)]
• Walking Endurance - 6-Minute Walk Test [Срок оценки: Baseline (Day 1)]
• Walking Endurance - 6-Minute Walk Test [Срок оценки: Immediately after therapy completion (Day 10)]
• Independent Mobility and Fall Risk - Timed "Get Up & Go" Test [Срок оценки: Baseline (Day 1)]
• Independent Mobility and Fall Risk - Timed "Get Up & Go" Test [Срок оценки: Immediately after therapy completion (Day 10)]
• Lower Limb Loading Symmetry - Two-Scale Test [Срок оценки: Baseline (Day 1)]
• Lower Limb Loading Symmetry - Two-Scale Test [Срок оценки: Immediately after therapy completion (Day 10)]

Вторичные конечные точки (4)

• Gait and Balance - Dynamic Gait Index [Срок оценки: Baseline (Day 1)]
• Gait and Balance - Dynamic Gait Index [Срок оценки: Immediately after therapy completion (Day 10)]
• Gait Asymmetry - Wisconsin Gait Scale [Срок оценки: Baseline (Day 1)]
• Gait Asymmetry - Wisconsin Gait Scale [Срок оценки: Immediately after therapy completion (Day 10)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07568821 · 1/11/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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