Operant Conditioning of Spinal Reflexes to Enhance Motor Function Recovery After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Change in walking speed (m/s) as measured by the 10-meter Walk Test (10MWT)
研究概览
简要总结
The purpose of this study is to validate the capacity of a reflex training system to change the size of the targeted reflex. For this, the researchers are recruiting 25 individuals with chronic incomplete SCI who have spasticity in the leg to participate in the reflex training procedure. The study involves approximately 45 visits with a total study duration of about 6 months.
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
- •a clinically stable spinal cord injury (above T11) that occurred at least one year previously
- •the ability to ambulate at least 10 m with or without an assistive device (i.e., walker, crutches, or cane, not parallel bars) within 100 sec (those with 10-meter walking time >100 sec are excluded because it is unlikely that they are able to participate in and complete our planned locomotion evaluation procedures)
- •clinical signs of spasticity in the plantarflexor muscles at least unilaterally (i.e., hyperreactivity to Achilles tendon tap, and increased muscle tone, score >1 on Modified Ashworth scale)
- •spastic hyperreflexia reflected in exaggerated H-reflex
- •functionally and medically stable for at least 3 months
- •medical clearance to participate
- •reasonable expectation that current medications (including antispasticity medication such as baclofen, diazepam, and tizanidine) will not change over the conditioning period. Each participant's medication and dosage will be monitored and recorded throughout the study. Once enrolled, the subject will remain enrolled even if medication changes. (Because only neurologically stable subjects will enter this study, medication changes will be unlikely.)
排除标准
- •motoneuron injury;
- •a cardiac condition (history of myocardial infarct, pacemaker use, etc.)
- •an unstable medical condition
- •a pre-existing or confounding neurological condition (e.g., history of Multiple Sclerosis (MS), Traumatic Brain Injury (TBI), Stroke, Parkinson's disease)
- •a condition that prevents lower extremity mobility testing or weight bearing (e.g. fracture, severe sprain/strain, botox muscular injection) (orthotic knee hyperextension is not excluded; in severe cases of knee hyperextension, the brace can be worn during the study sessions)
- •a cognitive impairment that precludes giving informed consent (e.g., severe intellectual disability)
- •use of a functional electrical stimulation (FES) foot-drop stimulator or an FES bicycle on a daily basis (FES applied to the arm is acceptable)
- •deep vein thrombosis within the past 6 months
- •depression (due to potential interference of anti-depressant medication with the intervention and possible reduced participation reliability)
- •pregnancy (due to expected changes in weight and posture and potentially unstable medical condition).
研究组 & 干预措施
Validation of the new training system
The researchers will measure changes in H-reflex size achieved with the use of the new system and compare these measures with the existing results in 25 spastic individuals with chronic incomplete SCI. Each participant completes 6 baseline sessions and 30 conditioning sessions. In the 30 conditioning sessions, the soleus H-reflex will be down-conditioned to decrease the activity of the hyperactive spinal stretch reflex pathway in people with spasticity that is characterized by exaggerated reflex activity. It is anticipated that the magnitude of reflex change obtained with the use of the new system would be greater or at least the same as the bench-marked values from the previous studies that used the old prototype reflex conditioning system.
干预措施: Spinal Reflex Operant Down Conditioning (Behavioral)
结局指标
主要结局
Change in walking speed (m/s) as measured by the 10-meter Walk Test (10MWT)
时间窗: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Speed of the participant's fastest comfortable walking speed across 10 meters. Decreased time (sec) demonstrates increased walking speed (m/s)
Change in walking distance (meters) as measured by the 6-minute walk test
时间窗: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
The distance walked in 6 minutes in measured. The participant is asked to walk at his/her fastest comfortable speed on an indoor walkway.
Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation
时间窗: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Decreased H-reflex amplitude indicates reduced reflex activity and a more normal reflex response to muscle activity
次要结局
- Change in quality of life as measured by Spinal Cord Injury Quality of Life and Participation Questionnaire (SCI-QOL)(Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention)
- Change in functional independence as measured by the Functional Independence Measure (FIM)(Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention)
- Change in dynamic and static muscle length and joint range of motion (ROM) as measured by Tardieu Scale(Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention)
- Change in balance as measured by Berg Balance Scale(Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention)
- Change in level of spasticity in the more affected leg as measured by the Modified Ashworth Scale (MAS)(Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention)
- Change in the level of assistance required to walk 10 meters as measured by the Walking Index for Spinal Cord Injury (WI-SCI)(Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention)
- Change in basic functional independence as measured by the Spinal Cord Independence Measure (SCIM III)(Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention)
- Change is strength of key muscles in the lower extremity as measured by Manual Muscle Testing (MMT)(Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention)
研究者
Aiko Thompson
Associate Professor
Medical University of South Carolina