Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Change in Gait Symmetry
研究概览
简要总结
This study has two interventional components, the first is a cross-over design and the second is a randomized control trial. Both 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:
- Exploratory phase: Identify a systematic, methodical approach to identifying the optimal stimulation parameters and gait training protocol for each individual patient with stroke.
- Aim 1: Evaluate short-term effects of transcutaneous spinal cord stimulation + gait training on gait symmetry, gait performance, and corticospinal circuitry in individuals with chronic stroke.
- Aim 2: Evaluate and predict long-term effects of transcutaneous spinal cord stimulation + gait training on gait symmetry, gait performance, and corticospinal circuitry in individuals with chronic stroke
- Aim 3: Identify parameters that distinguish responders from non-responders to transcutaneous spinal cord stimulation in individuals with chronic 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
- •Age 18 years or older
- •Able and willing to give written consent and comply with study procedures
- •At least 6 months' post-stroke
- •Hemiplegia secondary to a single stroke
- •Functional Ambulation Category of 2 or greater - i.e., subject needs continuous or intermittent support of one person to help with balance and coordination.
- •Not currently receiving regular physical therapy services
- •Physician approval to participate
排除标准
- •Multiple stroke history
- •Botox injection in lower extremity within the last 4 months
- •Modified Ashworth score of 3 or greater in lower extremity
- •Pregnant or nursing
- •Using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD) 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
- •Active cancer or cancer in remission less than 5 years
- •Orthopedic dysfunction, injury, or surgery that would impact an individual's ability to use the lower extremity.
- •Traumatic brain injury or other neurological conditions that would impact the study.
- •TMS-Specific Exclusion Criteria: TMS will be utilized for both Aims. The sub-set of participants who meet these criteria will participate in this component of the studies.
- •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
- •A concussion within the last 6 months
- •Unstable cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension, uncontrolled diabetes, or chronic emphysema)
研究组 & 干预措施
Aim 1: Gait Training + Stimulation
Up to 60 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.
干预措施: Noninvasive spinal stimulation with gait training (Device)
Aim 1: Gait Training + Stimulation
Up to 60 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.
干预措施: Exploratory Phase - Optimization of Gait Training and Spinal Stimulation (Other)
Aim 1: Gait Training + Sham Stimulation
Up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention while performing locomotion training. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.
干预措施: Conventional gait training (Device)
Aim 2: Gait Training + Stimulation
Up to 60 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.
干预措施: Noninvasive spinal stimulation with gait training (Device)
Aim 2: Gait Training + Stimulation
Up to 60 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.
干预措施: Exploratory Phase - Optimization of Gait Training and Spinal Stimulation (Other)
Aim 2: Gait Training + Sham Stimulation
Up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention while performing locomotion training. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground 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 Gait Symmetry
时间窗: Aim 1: Baseline pre-intervention immediately post intervention for interventions 1, 2, 3 and 4. Aim 2: Baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2.
Participants will ambulate along Gait Rite electronic walkway 3 times per gait speed to evaluate gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway contains sensor pads encapsulated in a carpet and connected to a computer. The system can be laid over any flat surface and automates measuring temporal and spatial gait parameters. 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.
次要结局
- Change in 6 Minute Walk Test(Aim 2: Baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2.)
- Change in 10 Meter Walk Test(Aim 1: Baseline pre-intervention immediately post intervention for interventions 1, 2, 3 and 4. Aim 2: Baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2.)
研究者
Arun Jayaraman, PT, PhD
Principal Investigator
Shirley Ryan AbilityLab