Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Step-length Symmetry Using Symmetry Index
研究概览
简要总结
This is a randomized control trial that will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke.
详细描述
OBJECTIVES:
- To determine whether transcutaneous spinal cord stimulation combined with ambulation training modulates corticospinal locomotor networks in individuals with chronic hemiplegic stroke
- To determine whether transcutaneous spinal stimulation combined with ambulation training improves locomotor function in individuals with chronic hemiplegic stroke
- To determine whether transcutaneous spinal stimulation combined with ambulation training improves symmetry of gait in individuals with chronic hemiplegic stroke
- To determine whether transcutaneous spinal stimulation combined with ambulation training improves standing posture and balance in individuals with chronic hemiplegic stroke
- To determine whether ambulation efficiency (improved cardiovascular conditioning) improves with transcutaneous non-invasive spinal stimulation and locomotor training in individuals with chronic hemiplegic stroke
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
- 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
- •Healthy Control Group Inclusion Criteria:
- •Age 18 or older
- •Able and willing to give written consent and comply with study procedures
- •Healthy Control Group
排除标准
- •No history of cerebrovascular accidents or neurological degenerative pathologies (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
- •Pregnant or nursing
- •Skin allergies or irritation; open wounds
- •Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)
- •Stroke Group Inclusion Criteria:
- •Participants are 18 years of age or older
- •Participants are at least 4 weeks post stroke
- •Participants with hemiplegia secondary to a single stroke
- •Functional Ambulation Category of 2 or greater - Patient needs continuous or intermittent support of one person to help with balance and coordination.
- •Participants are able to provide informed consent
- •Participants are not currently receiving regular physical therapy services
- •Stroke Group Exclusion Criteria:
- •Individuals less than18 years of age
- •Individuals less than 4 weeks post stroke
- •Individuals with ataxia
- •Individuals with multiple stroke history
- •Currently taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Tricyclic antidepressant (TCA)
- •Botox injection in lower extremity within the last 4 months
- •Modified Ashworth score of 3 or greater in lower extremity
- •Pregnancy or nursing
- •Pacemaker or anti-spasticity implantable pumps
- •Active pressure sores
- •Unhealed bone fractures
- •Peripheral neuropathies
- •Painful musculoskeletal dysfunction due to active injuries or infections
- •Severe contractures in the lower extremities
- •Medical illness limiting the ability to walk
- •Active urinary tract infection
- •Clinically significant depression, psychiatric disorders, or ongoing drug abuse
- •Metal implants in their spine TMS Specific Criteria (see Safety Screening Questionnaire for Transcranial Magnetic Stimulation)
- •Medicated with agents known to increase (e.g., amphetamines) or decrease motor system excitability (e.g., lorazepam)
- •Implanted cardiac pacemaker
- •Metal implants in the head or face
- •Suffers unexplained, recurring headaches
- •Had a seizure in the past unrelated to the stroke event, or has epilepsy
- •Skull abnormalities or fractures
- •Suffered a concussion within the last 6 month
- •Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
研究组 & 干预措施
Noninvasive Spinal Stimulation with Gait Training
May receive up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression.
干预措施: Noninvasive spinal stimulation with gait training (Device)
Conventional Gait Training
May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression.
干预措施: Conventional gait training (Device)
结局指标
主要结局
Change in Step-length Symmetry Using Symmetry Index
时间窗: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)
Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-\|1-Nonparetic/(Paretic side)\|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher scores = better outcome.
Change in Swing-time Symmetry
时间窗: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)
Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-\|1-Nonparetic/(Paretic side)\|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher scores = better outcome.
次要结局
- Change in 10 Meter Walk Test - Self-selected Velocity(Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total))
- Change in 10 Meter Walk Test - Fast Velocity(Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total))
- Change in 6 Minute Walk Test(Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total))
- Change in PCI During 6 Minute Walk Test(Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total))
研究者
Arun Jayaraman, PT, PhD
Director Max Näder Center
Shirley Ryan AbilityLab