Locomotor Function Following Acute Intermittent Hypoxia (AIH) and Transcutaneous Electrical Spinal Cord Stimulation (tSCS) With Gait Therapy Versus Traditional Gait Therapy in Individuals With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in 6 Minute Walk Test
研究概览
简要总结
This is a single blind, sham controlled crossover trial that will evaluate the effectiveness of acute intermittent hypoxia therapy (AIH) combined with transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals after spinal cord injury.
详细描述
OBJECTIVES:
- To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training modulates spinal locomotor networks in individuals with spinal cord injury
- To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training improves locomotor function in individuals with spinal cord injury
- To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training improves symmetry of gait in individuals with spinal cord injury
- To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training improves standing posture and balance in individuals with spinal cord injury
- To determine whether ambulation efficiency (improved cardiovascular conditioning) improves with a combination of AIH, transcutaneous spinal cord stimulation and ambulation training in individuals with spinal cord injury
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
- Single (Participant)
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
- •Participants have been diagnosed with a spinal cord injury below level C2
- •ASIA Impairment Scale Grade A-D
- •Participants are 18 years of age or older
- •Participants are at least 6 months post spinal cord injury
- •Participants with paraplegia or tetraplegia secondary to a single spinal cord injury
- •Participants are able to provide informed consent
- •Participants are not currently receiving regular physical therapy services
排除标准
- •Individuals less than 18 years of age
- •Individuals less than 6 months post spinal cord injury
- •Individuals with ataxia
- •Individuals with multiple spinal cord injury history
- •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
- •Active urinary tract infection
- •Clinically significant depression, psychiatric disorders, or ongoing drug abuse
- •Diagnosed with any of the following medical conditions: congestive heart failure, cardiac arrhythmias, uncontrolled hypertension, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, emphysema, severe asthma, previous myocardial infraction, or known carotid/intracerebral artery stenosis
- •Individuals with a tracheostomy or who utilize mechanical ventilation.
- •Individuals who are currently enrolled in another interventional research study or in therapy related to upper extremity function.
- •Participants will be excluded if they have had a botulinum toxin injection to lower extremity musculature within the last 3 months. Participants will need to refrain from lower extremity botulinum toxin injections for the duration of the study. If participants wean off antispasticity medications to successfully complete the responsiveness to AIH screening session, they will need to refrain from the medications for the duration of the study.
- •Documented sleep apnea.
- •Orthopedic injuries or surgeries that would impact an individual's ability to use the lower extremity.
- •Traumatic brain injury or other neurological conditions that would impact the study.
- •Blood hemoglobin levels less than 10g/dL.
- •We will not include the following populations:
- •Adults unable to consent, unless accompanied by a legally authorized representative.
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
结局指标
主要结局
Change in 6 Minute Walk Test
时间窗: Baseline (initial visit within an arm), Intervention session 5 within each arm (T5), 3 days after intervention sessions complete within each arm (POST), 1 week after intervention sessions are complete within each arm (1-week follow up)
The 6 Minute Walk Test (6MWT) measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assertive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test was completed at 4 time points within each arm: 1) Baseline prior to starting each arm, 2) intervention session 5 within each arm (T5), 3) 3 days after the intervention sessions were complete for the given arm (POST), and 4) 1 week after all intervention sessions were complete for a given arm (1-week follow up)
次要结局
- Change in 10 Meter Walk Test, Fast Velocity(Baseline (initial visit within an arm), Intervention session 5 within each arm (T5), 3 days after intervention sessions complete within each arm (POST), 1 week after intervention sessions are complete within each arm (1-week follow up))
- Timed Up and Go Test: Assesses Mobility, Balance, Walking Ability and Fall Risk(Baseline (initial visit within an arm), Intervention session 5 within each arm (T5), 3 days after intervention sessions complete within each arm (POST), 1 week after intervention sessions are complete within each arm (1-week follow up))
研究者
Arun Jayaraman, PT, PhD
Director Max Nader Laboratory
Shirley Ryan AbilityLab