Combined Virtual Reality-Integrated C-Mill® and Conventional Therapy Improves Walking, Mobility, and Quality of Life After Motor-Incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Berg Balance Scale
研究概览
简要总结
This study investigates the effects of C-Mill® treadmill training, which integrates virtual reality and gamified tasks, combined with conventional physiotherapy, on walking ability, mobility, functional independence, and health-related quality of life in individuals with motor-incomplete spinal cord injury (iSCI).
Participants are adults aged 18 years or older with injury at the T4 level or below, classified as American Spinal Injury Association (ASIA) Impairment Scale grade C or D, and with ICD-10 codes S24.73-S24.77 or S34.70. Individuals with a history of osteoporosis, cardiopulmonary disease, other neurological disorders, joint-related conditions, or concurrent participation in another study are excluded.
All participants complete a 4-week integrated rehabilitation program at a specialized spinal cord injury center. The program consists of 10 C-Mill® sessions in addition to conventional physiotherapy, targeting balance, gait, and walking speed through task-specific training and individualized exercises to improve mobility, strength, and functional skills.
详细描述
Spinal cord injury (SCI) limits mobility and independence, creating substantial physical and psychological burdens. Virtual reality and gamified treadmill systems such as the C-Mill® may enhance walking rehabilitation through task-specific and engaging practice.
This observational study investigated the effects of C-Mill® treadmill training combined with conventional physiotherapy on walking ability, mobility, functional independence, and health-related quality of life in individuals with motor-incomplete SCI (iSCI). The C-Mill® system provides task-specific, engaging, and safe walking practice through real-time visual feedback and interactive scenarios designed to improve balance, gait speed, and obstacle negotiation.
Participants were adults aged 18 years or older, with spinal cord injury at the T4 level or below, classified as American Spinal Injury Association (ASIA) Impairment Scale grade C or D. ICD-10 codes for inclusion ranged from S24.73 to S24.77 or S34.70. Individuals were in the chronic phase of iSCI and were excluded if they had a history of osteoporosis, cardiopulmonary disease, other neurological disorders, joint-related conditions, or concurrent participation in another study.
All participants completed a 4-week integrated rehabilitation program at a specialized spinal cord injury center. The program consisted of 10 C-Mill® training sessions in addition to conventional physiotherapy. Each C-Mill® session included activities targeting static and dynamic balance, stride regulation, and safe gait adaptation, with progressive difficulty tailored to each participant's abilities. Conventional therapy included individualized physiotherapy exercises focusing on mobility, strength, and functional skills to support walking performance and independence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Diagnosis of spinal cord injury at T4 level or lower
- •American Spinal Injury Association (ASIA) Impairment Scale classification of grade C or D
- •ICD-10 codes S24.73 to S24.77 or S34.70
排除标准
- •History of osteoporosis
- •Cardiopulmonary disease
- •Other neurological disorders
- •Joint-related conditions
- •Concurrent participation in another study
研究组 & 干预措施
C-Mill® Treadmill Training Plus Conventional Physiotherapy
Participants received an integrated rehabilitation program consisting of C-Mill® treadmill training combined with conventional physiotherapy. The program lasted 4 weeks and included 10 C-Mill® sessions in addition to individualized physiotherapy exercises. Each C-Mill® session incorporated virtual reality and gamified tasks to improve static and dynamic balance and to regulate gait. Conventional physiotherapy focused on mobility, muscle strength, and functional skills to enhance walking performance and independence.
干预措施: C-Mill® Treadmill Training Combined with Conventional Physiotherapy (Device)
结局指标
主要结局
Berg Balance Scale
时间窗: 24 months
Berg Balance Scale for balance assessment
次要结局
- ASIA Lower Extremity Muscle Score(24 months)
- Timed Up and Go Test(24 months)
- Walking Index in Spinal Cord Injury II(24 months)
- Ten-Meter Walking Test(24 months)
- Gait Speed with Treadmill-Based Gait Analysis(24 months)
- Cadence Measurement with Treadmill-Based Gait Analysis(24 months)
- Stride Length Measurement with Treadmill-Based Gait Analysis(24 months)
- Step Width Measurement with Treadmill-Based Gait Analysis(24 months)
- Stance Time Difference with Treadmill-Based Gait Analysis(24 months)
- Spinal Cord Independence Measure (SCIM III)(24 months)
- World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)(24 months)