Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in score on Walking Index for SCI (WISCI) II
研究概览
简要总结
The goal of this clinical trial is to investigate the effects of transcutaneous spinal cord stimulation (TSCS) combined with exoskeleton training, as compared to exoskeleton training alone to improve motor function in individuals with incomplete spinal cord injury who are 12 months or less post-injury. Participants will be randomly assigned to a treatment group (exoskeleton training with TSCS, or exoskeleton training without TSCS). Participants in both groups will undergo a baseline evaluation, then take part in 24, 1-hour training sessions at Craig Hospital. After the 24 sessions have concluded, participants will undergo a post-treatment evaluation as well as a follow-up evaluation four weeks after training is completed. Researchers will compare the two groups by evaluating the following areas:
- walking ability and speed
- lower extremity strength, activation, and spasticity
- trunk control
- bowel and bladder function
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
- Double (Participant, Outcomes Assessor)
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
- •< 12 months post traumatic iSCI C4-T10 with signs of upper motor neuron injury
- •AIS C or D classification
- •18 years and older
- •Height 5'0" to 6'4"
- •Weight 220lbs or less
- •Sufficient upper extremity strength to manage a stability aide
- •Medical clearance for high intensity gait training
- •Walking <1.46 m/s
- •Intact skin in on pelvis, lower extremities and back
- •Passive range of motion at shoulders, trunk, hips, knees & ankles within functional limits
排除标准
- •Unstable or symptomatic cardiac or respiratory issues
- •Recent history of fracture, contractures, pressure injury, deep vein thrombosis, or other infection that might interfere with participation in study
- •Received Botox injections to the lower extremities within the last six months
- •Pregnancy
- •Cauda Equina injury
- •Any other issue that in the opinion of the investigator would impact study participation
- •Non-English Speaking
研究组 & 干预措施
Exoskeleton+Transcutaneous Spinal Cord Stimulation
Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a therapeutic level of transcutaneous spinal cord stimulation (TSCS) thoracolumbar spinal cord areas. Focus will be on stepping at a high intensity throughout the session as measured by heart rate.
干预措施: Exo + TSCS (Device)
Exoskeleton+Sham Stimluation
Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a non-therapeutic level of stimulation (considered to be a sham). Focus will be on stepping at a high intensity throughout the session as measured by heart rate.
干预措施: Exo + Sham (Device)
结局指标
主要结局
Change in score on Walking Index for SCI (WISCI) II
时间窗: Baseline to Immediately After Intervention
Assesses the amount of physical assistance/devices needed for walking following paralysis from SCI (scale of 0-20 with higher score indicating less need for assistance)
次要结局
- Change in lower extremity strength as measured by Lower Extremity Motor Score (LEMS)(Baseline to Post-treatment)
- Change in balance/trunk control as measure by the Function in Sitting Test Spinal Cord Injury(Baseline to Immediately After Intervention)
- Change in bladder function as measured by Neurogenic Bladder Symptom Scale(Baseline to Immediately After Intervention)
- Change in distance walked as measured by the 6 Meter Walk Test(Baseline to Immediately After Intervention)
- Change in spasm frequency and severity as measured by Penn Spasm Frequency(Baseline to Immediately After Intervention)
- Change in bowel function as measured by Neurogenic Bowel Dysfunction Scale(Baseline to Immediately After Intervention)
- Change in walking speed as measured by the 10 Meter Walk Test(Baseline to Immediately After Intervention)