Dosing of Overground Robotic Gait Training With Functional Outcomes and Neuroplasticity 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
- 98
- 试验地点
- 1
- 主要终点
- Change in Walking Index for Spinal Cord Injury - II (WISCI-II) from baseline
研究概览
简要总结
The DOOR SCI project examines dosing effects of robotic gait training (RGT) and transcranial magnetic stimulation (TMS) initiated during inpatient rehabilitation and continued through early outpatient rehabilitation
详细描述
Emerging evidence indicates that robotic exoskeleton use results in positive outcomes for those with chronic SCI, yet limited evidence exists for the acute setting. The potential benefit of RGT initiated during inpatient rehabilitation when recovery is greatest is unknown yet appears promising due to established principles of neuroplasticity and the fact that RGT incorporates the critical components of gait training. As a result of the lack of evidence, no clinical practice guidelines exist that delineate which gait retraining approach or dose during early phases of recovery results in the best outcomes for people with motor incomplete SCI. The DOOR SCI project examines dosing effects on 5 occasions over 9 months: (1) inpatient rehabilitation admission and (2) discharge, (3) after completing 24 RGT sessions, (4) 1-month post RGT, and (5) 9-months post SCI). To test the overarching goal, investigators propose three specific aims:
Aim 1: Using a randomized controlled trial, prospectively examine whether the dosing frequency [24 sessions delivered as high, moderate, or low frequency, defined by number days/week (4, 3, or 2 days/week over 6, 8, 12 weeks)] of RGT therapy provided during the acute/subacute recovery phase after motor incomplete SCI impacts outcomes compared to usual care only.
Aim 2: Investigate the difference over 9 months of the neuroplastic effect of RGT dosing as measured by single pulse TMS.
Aim 3: Evaluate the safety, tolerability, and feasibility of delivering different dosing frequencies of RGT from inpatient to outpatient rehabilitation settings.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
All clinical and study specific assessments will be completed by trained assessors blinded to group allocation. Clinical assessments will be completed by a physical therapist (e.g., WISCI-II, SCIM). Study specific assessments (e.g., FSS, actigraphy, TMS) will be conducted by study staff and investigator. Subjects will not be blinded to group allocation.
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All types of motor incomplete SCI (traumatic and non-traumatic)
- •Acute/Subacute phase of recovery
- •Medically stable as deemed by physician
- •Undergoing medical care and rehabilitation at Baylor Scott & White Institute for Rehabilitation
- •Both genders and all races and ethnicities
- •Meet the Ekso robotic exoskeleton frame limitations
- •Continence of or a program for bladder and bowel management
排除标准
- •Concurrent moderate to severe traumatic brain injury (TBI)
- •Degenerative diagnoses
- •Pre-morbid developmental disability, significant psychological diagnosis, or other cognitive impairment
- •Pregnancy
研究组 & 干预措施
Low Frequency
Subjects will receive 2 sessions of robotic gait training (RGT) per week for 12 weeks
干预措施: Robotic Gait Training (Device)
Moderate Frequency
Subjects will receive 3 sessions of robotic gait training (RGT) per week for 8 weeks
干预措施: Robotic Gait Training (Device)
High Frequency
Subjects will receive 4 sessions of robotic gait training (RGT) per week for 6 weeks
干预措施: Robotic Gait Training (Device)
Control Group
Subjects will receive usual care gait training without robotic gait training
干预措施: Usual Care (UC) Gait Training (Other)
结局指标
主要结局
Change in Walking Index for Spinal Cord Injury - II (WISCI-II) from baseline
时间窗: Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset
The WISCI-II defines the physical limitation for gait secondary to impairment at the person level and indicates the ability of a person to walk after SCI. The WISC-II rank orders the ability a person to walk on a scale of 0-20 with 0 representing no ability to stand or participate in assisted walking and 20 representing an ability to walk 10 meters with no devices, no braces, and no physical assistance.
次要结局
- Change in Fatigue Severity Scale (FSS)(Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset)
- Change in Patient Health Questionnaire - 9 (PHQ-9)(Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset)
- Change in 10-Meter Walk Test (10MWT)(Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset)
- Change in Spinal Cord Independence Measure (SCIM)(Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset)
- Change in Numerical Pain Rating Scale (NPRS)(Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset)
- Change in Penn Spasm Frequency Scale (PSFS)(Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset)
- Change in Life Satisfaction Questionnaire (LISAT)(Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset)
- Change in Physical Activity by GT9x Actigraph accelerometer(Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset)
- Change in Neurophysiologic biomarkers by single pulse transcranial magnetic stimulation (TMS)(Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset)
研究者
Chad Swank
Research Investigator
Baylor Research Institute