The Effect of Adding Functional Electrical Stimulation Bicycle Ergometry to Robotic Rehabilitation on Walking Function and Lower Extremity Functional Recovery in Patients With Chronic Incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Walking Index for Spinal Cord Injury (WISCI II)
研究概览
简要总结
Spinal cord injury (SCI) is a devastating neurological condition resulting from either traumatic or non-traumatic causes, leading to loss of motor, sensory, and autonomic functions in individuals. Statistics indicate that more than 75% of individuals with incomplete SCI regain some degree of ambulatory function.
Authors' aim in this study is to investigate the effect of adding functional electrical stimulation (FES) bicycle ergometry to robotic rehabilitation on lower extremity functional recovery and ambulation in patients with chronic incomplete SCI.
详细描述
Spinal cord injury (SCI) is a devastating neurological condition resulting from either traumatic or non-traumatic causes, leading to loss of motor, sensory, and autonomic functions in individuals. Statistics indicate that more than 75% of individuals with incomplete SCI regain some degree of ambulatory function. To the authors' knowledge, no other study has investigated the effect of adding FES bicycle ergometry to robotic rehabilitation on lower extremity functional recovery and ambulation in patients with chronic incomplete SCI. Authors' hypothesis is that the group receiving FES bicycle ergometry in addition to robotic rehabilitation will achieve better functional recovery and ambulation compared to the group receiving only robotic rehabilitation. In this context, authors' aim in this study is to investigate the effect of adding functional electrical stimulation bicycle ergometry to robotic rehabilitation on lower extremity functional recovery and ambulation in patients with chronic incomplete SCI.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Motor Incomplete spinal cord injury (ASIA C and D).
- •At least 6 months post spinal cord injury.
- •Age between 18 and 65 years.
- •Ability to walk at least 10 meters independently or with assistive devices such as a cane or crutches.
- •Signed informed consent form indicating willingness to participate in the study.
排除标准
- •Severe spasticity or joint contracture in the lower extremities that impedes movement.
- •Presence of metallic implants in the lower extremities.
- •Stage 2 or higher pressure ulcers on the sacral or coccygeal regions.
- •Co-existing peripheral neuropathy.
- •Permanent urinary catheter use.
- •Contraindications for walking exercises (e.g., cognitive impairment preventing exercise compliance, unstable epilepsy or unexplained convulsions, unstable acute cardiac arrhythmia or heart failure, presence of a cardiac pacemaker).
- •Psychiatric disorders or cognitive problems that prevent completing questionnaires and assessment scales.
- •Presence of other neurological or muscular diseases.
结局指标
主要结局
Walking Index for Spinal Cord Injury (WISCI II)
时间窗: at baseline and change from baseline WISCI II at 4 weeks
An index that evaluates walking ability post-SCI, scoring from 0 to 20 based on the need for personal assistance, use of orthoses, walkers, crutches, canes, or no assistive devices. Scores for the WISCI II scale range from 0 to 20 (0: most severe impairment, 20: mild impairment).
次要结局
- Ten (10)-Meter Walk Test(at baseline and change from baseline 10-meter walk test at 4 weeks)
- Two (2)-Minute Walk Test(at baseline and change from baseline 2-minute walking test at 4 weeks)
- Timed Up and Go Test (TUGT)(at baseline and change from baseline TUGT at 4 weeks)
- Lower Extremity Motor Score (LEMS)(at baseline and change from baseline LEMS at 4 weeks)
- Spinal Cord Independence Measure (SCIM)(at baseline and change from baseline SCIM at 4 weeks)
研究者
Merve Örücü Atar
Associate professor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital