Evaluation of the Effectiveness of Rehabilitation in Patients With Gait Pattern Asymmetry Using a Virtual Reality
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Gait speed - 10-meter walk test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
VR Therapy and Standard Rehabilitation
干预措施: Virtual Reality (VR) and Standard Rehabilitation (Other)
Control: Standard Rehabilitation
干预措施: Standard Rehabilitation (Other)
结局指标
主要结局
Gait speed - 10-meter walk test
时间窗: Baseline (Day 1)
Gait speed - 10-meter walk test
时间窗: Immediately after therapy completion (Day 10)
Walking Endurance - 6-Minute Walk Test
时间窗: Baseline (Day 1)
Walking Endurance - 6-Minute Walk Test
时间窗: Immediately after therapy completion (Day 10)
Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
时间窗: Baseline (Day 1)
Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
时间窗: Immediately after therapy completion (Day 10)
Lower Limb Loading Symmetry - Two-Scale Test
时间窗: Baseline (Day 1)
Lower Limb Loading Symmetry - Two-Scale Test
时间窗: Immediately after therapy completion (Day 10)
次要结局
- Gait and Balance - Dynamic Gait Index(Baseline (Day 1))
- Gait and Balance - Dynamic Gait Index(Immediately after therapy completion (Day 10))
- Gait Asymmetry - Wisconsin Gait Scale(Baseline (Day 1))
- Gait Asymmetry - Wisconsin Gait Scale(Immediately after therapy completion (Day 10))
研究者
Agnieszka Guzik, PhD
Principal investigator
University of Rzeszow