Foundational Ingredients of Robotic Gait Training for People with Spinal Cord Injury During Inpatient Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Walking Index for Spinal Cord Injury - II (WISCI-II)
研究概览
简要总结
The FIRST project compares the dose of robotic gait training (RGT) with usual care gait training for patients with spinal cord injury (SCI) undergoing rehabilitation at Baylor Scott & White Institute for Rehabilitation (BSWIR).
详细描述
Spinal cord injury (SCI) due to trauma is estimated to affect 288,000 - 500,000 Americans, with about 17,700 new cases annually. Recovery of walking is a primary rehabilitation goal for patients and encouraged by therapists due to its relationship to quality of life, impact on health, psychological profile, and social participation after SCI. Recent technological advances with exoskeleton devices specifically for gait training may yield better walking recovery outcomes compared with usual care intervention approaches, such as body-weight support treadmill training (BWSTT) and overground gait training with braces, yet limited evidence exists for those with SCI.
Aim 1: Use a Community-Based Participatory Research approach to develop an robotic gait training (RGT) program that meets the unique needs of people after incomplete SCI during inpatient rehabilitation. This will be achieved by establishing and engaging an Advisory Board of key stakeholders to review evidence-based literature, advise the research team on the unique aspects and goals of inpatient rehabilitation for people with SCI, review the RGT, and make recommendations for amendments to the RGT program based on our interim and final outcomes of the study over the funding period.
Aim 2: Prospectively examine the efficacy of RGT compared to usual care gait training during inpatient rehabilitation in people with incomplete SCI.
Aim 3: Compare the intensity of RGT and usual care gait training during inpatient rehabilitation.
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
- Single (Outcomes Assessor)
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
- •16 - 85 Years of Age
- •All types of incomplete Spinal Cord Injury (SCI) (traumatic and non-traumatic)
- •Acute/Subacute phase of recovery
- •Medically stable as deemed by physician
- •Undergoing medical care and inpatient rehabilitation at BSW
- •Both genders and all races and ethnicities
- •Meet the Ekso robotic exoskeleton frame limitations
- •Continence of or a program for bladder and bowel management
- •Exclusion Criteria
- •Moderate to Severe Traumatic Brain Injury (TBI)
- •Degenerative diagnoses
- •Wound located in proximity to the exoskeleton frame
- •Severe osteoporosis/-penia as shown with dual energy x-ray absorptiometry (DXA)
- •Pre-morbid developmental disability, significant psychological diagnosis, or other cognitive impairment
排除标准
- 未提供
结局指标
主要结局
Walking Index for Spinal Cord Injury - II (WISCI-II)
时间窗: Within one week before discharge
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. 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
- Spinal Cord Independence Measure (SCIM)(Within one week of admission before start of treatment; Within one week before discharge)
- Heart Rate (HR)(Immediately following every treatment until discharge, an average of 28 days)
- Gait speed via 10-Meter Walk Test (10MWT)(Within one week of admission before start of treatment; Within one week before discharge)
- Numerical Pain Rating Scale (NPRS)(Within one week of admission before start of treatment; Within one week before discharge)
- Penn Spasm Frequency Scale (PSFS)(Within one week of admission before start of treatment; Within one week before discharge)
- Number of Steps(Immediately following every treatment session until discharge, an average of 28 days)
- Patient Perceptual Survey(Within one week before discharge)
- Patient Health Questionnaire - 9 (PHQ-9)(Within one week of admission before start of treatment; Within one week before discharge)
- Ratings of Perceived Exertion (RPE)(Immediately following every treatment session until discharge, an average of 28 days)
- International Spinal Cord Injury Quality of Life Basic Data Set(Within one week of admission before start of treatment; Within one week before discharge)
- Fatigue Severity Scale (FSS)(Within one week of admission before start of treatment; Within one week before discharge)
- General Anxiety Disorder (GAD-7)(Within one week of admission before start of treatment; Within one week before discharge)
研究者
Chad Swank
Principal Investigator
Baylor Research Institute