Skilled Motor Training and tDCS to Improve Leg Function After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change From Baseline Midswing Ankle ROM
研究概览
简要总结
The study investigates the effect of using transcranial direct current stimulation (tDCS) and skilled stepping training versus skilled stepping training with sham-tDCS in improving ankle and leg motor control in persons with ambulatory persons with spinal cord injury.
Hypotheses H1: Participants will display greater improvement in stepping function following tDCS combined with training compared to sham-tDCS and training.
H2: Participants will display greater gains in cortical excitability, as evidenced by lower cortico-motor threshold (MT) associated with the TA muscles following tDCS and training compared to following sham stimulation and training.
H3: Participants in the tDCS+training group will show greater increases walking speed in a timed 10 meter walking trial.
H4: Participants in the tDCS+training group will show be able to perform a greater number of toe-taps test.
详细描述
An estimated 265,000 individuals live with the consequences of SCI in the United States alone. Individuals with motor incomplete spinal cord injury (MISCI) commonly experience loss or impairment of lower extremity function. There are a limited number of options for restoration of walking function in individuals with motor-incomplete spinal cord injury (MISCI) who exhibit some ability to stand and walk but may be impeded by impaired voluntary control of the lower limb particularly, the ankle.
In persons with spinal cord injury, walking function is often limited by poor ability to lift and advance the legs. Lower extremity orthotic devices may be employed to stabilize the ankle joint and provide toe clearance during walking. However, these devices are cumbersome, and may be aesthetically unappealing.
Newer evidence indicates that non-invasive approaches to brain stimulation may provide a way to improve voluntary control of the legs and ankles in persons with neurologic disorders.
Purpose of this research study:
The overall goal of this study is to develop functional rehabilitation strategies that facilitate optimal restoration of leg and ankle motor control in individuals with MISCI. Individuals with MISCI exhibit some motor function below the level of lesion and include American Spinal Injury Association Impairment Scale (AIS) classifications AIS C and AIS D. We propose to test non-invasive cortical stimulation in combination with lower-extremity functional motor training for its ability to assist in improving fine motor control of the lower limbs in individuals with MISCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 injured subjects.
- •Ability to walk 10 m with or without walking aides.
- •Ability to Dorsiflex (Move foot up) at least 5 degrees from sitting.
排除标准
- •Cognitive function impairment
- •Brain surgery or intracranial metal implants.
结局指标
主要结局
Change From Baseline Midswing Ankle ROM
时间窗: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait.
Change From Baseline Active Motor Threshold
时间窗: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Measuring Active motor threshold using single pulse transcranial magnetic stimulation (TMS) of Motor cortex M1 area
次要结局
- Change From Baseline Score on Toe Tap Test(Two times, 1) Baseline, and 2) Up to 1 hour after intervention.)
- Change From Baseline Scores of a 10 m Walk Test(Two times, 1) Baseline, and 2) Up to 1 hour after intervention.)
研究者
Edelle Field-Fote
Professor
University of Miami