The Effect of High Intensity Exoskeleton Assisted Gait Training for Spinal Cord Injured Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
Background and Rationale:
Traumatic spinal cord injury (SCI) affects approximately 12,400 individuals annually in the USA, predominantly impacting healthy young adults aged 20-40 years. Complete SCI above the lumbar region results in paraplegia or tetraplegia, severely compromising quality of life. Wheelchair-dependent lifestyle and immobilization lead to serious secondary complications including osteoporosis, diabetes mellitus, atherosclerosis, pressure ulcers, depression, and pathological fractures. Robotic exoskeletons have emerged as promising rehabilitation tools since the 2000s, enabling independent walking and stair climbing beyond wheelchair use.
Study Objectives:
This clinical trial investigates the role of ReWalk lower-limb human exoskeleton in rehabilitation by:
Integrating exoskeleton-assisted gait training into rehabilitation protocols and comparing functional and physiological outcomes with conventional conservative treatment in SCI-induced paralysis Examining gastrointestinal and urogenital changes Assessing general well-being and patient compliance
Methods:
This prospective, controlled study enrolls patients with lower limb paralysis following SCI for minimum 6-month rehabilitation. The control group receives traditional physiotherapy and physical rehabilitation only. All procedures comply with Good Clinical Practice principles and applicable regulations.
Inclusion criteria (FDA-approved): Complete SCI below T4 with paraparesis/paraplegia; ≥4 months post-injury; adequate arm/shoulder strength for crutch use; appropriate bone density (hip t-score >-3.5); intact skeletal system with stable spine; ability to stand safely; good general health; height 160-190cm; weight ≤100kg; adequate lower limb range of motion.
Exclusion criteria: Severe neurological diseases beyond SCI; significant concurrent illnesses; severe spasticity (Modified Ashworth 4); unstable spine or limbs; heterotopic ossification; significant contractures; psychiatric/cognitive impairment; pregnancy.
Training Protocol:
The rehabilitation program consists of five phases:
Paravertebral and back muscle strengthening (weeks 1-4): Core strengthening exercises focusing on sitting balance, assessed weekly via trunk control measurement scale Standing, sitting, and device donning (weeks 5-6): Learning independent device application and safe standing balance Gait training (weeks 7-8): Mastering independent device control through various stepping patterns Stair training (weeks 9+): Learning stair negotiation after passing final skill test Follow-up phase (6+ months): Maintenance therapy at reduced frequency (3x/week)
Assessment Parameters:
Baseline assessments include: ASIA Impairment Scale, bone densitometry, Modified Ashworth Scale, Barthel Index, Functional Independence Measure (FIM), VAS pain/fatigue scales, SF-36, Beck's anxiety/depression inventories.
Progress evaluations at major milestones include functional tests (10-meter walk, Timed Up-and-Go, Berg Balance, Spinal Cord Independence Measure) and ReWalk skill assessments.
Follow-up assessments (6-month minimum) repeat baseline measures focusing on bone density, functional independence, quality of life, and mental health.
Expected Outcomes:
Improved bone density with exoskeleton training compared to conventional treatment Improved general well-being and better patient compliance This study aims to confirm previous international findings demonstrating superior outcomes with robotic rehabilitation technology regarding spasticity reduction, bone density preservation, body composition improvement, and gastrointestinal/urogenital/mental health enhancement compared to traditional treatment approaches.
详细描述
Background and rationale Traumatic spinal cord injury (SCI) has major epidemiological and societal impact. Incidence is approximately 12,400 new cases/year in the USA, with a proportionally similar rate expected in Hungary. SCI most often results from traffic-related injuries and typically affects young, previously healthy adults (20-40 years). Depending on neurological level and severity, SCI may cause paraparesis/paraplegia or tetraparesis/tetraplegia, leading to profound functional limitations and reduced quality of life.
For individuals with complete SCI above the lumbar region, independent standing and walking are generally not achievable with current standard care. Long-term wheelchair use and immobilization contribute to common secondary complications, including osteoporosis, diabetes mellitus, atherosclerosis, pressure ulcers, depression, and pathological fractures. Therefore, a central goal of rehabilitation after complete SCI is to prevent or minimize immobilization-related complications and to support the highest possible level of independence and quality of life.
Robotic lower-limb exoskeletons have been introduced into rehabilitation since the 2000s. These externally worn robotic frames can enable upright standing, walking, and potentially stair negotiation, supplementing wheelchair mobility. Prior clinical studies indicate that the ReWalk exoskeleton is feasible and safe for supervised clinical rehabilitation and, in selected users, for home/community use. Exoskeleton-assisted gait produces measurable cardiorespiratory demands and may replicate some beneficial physiological effects of able-bodied walking. Published data suggest possible improvements in functional walking capacity compared with some conventional gait-assist approaches (e.g., dynamic gait orthoses), and potential benefits in spasticity, as well as urogenital and gastrointestinal function, patient acceptance, sleep, well-being, and depressive symptoms.
Based on these findings, the present study is designed to compare outcomes of ReWalk-based robotic gait rehabilitation with outcomes achieved by conventional physiotherapy/fiziotherapy in a similar SCI population, with special attention to domains where exoskeleton-assisted upright mobility may provide added value (e.g., spasticity, bone density, body composition, autonomic functions, and mental health).
Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Complete spinal cord injury below thoracic vertebra level 4 with paraparesis or paraplegia
- •At least 4 months since the spinal cord injury
- •Adequate arm and shoulder muscle condition to use forearm crutches
- •Adequate bone density; if needed confirmed by dual energy X ray absorptiometry: hip T score greater than minus 3.5
- •Intact skeletal system; stable or stabilized spinal injury, with no fresh, non consolidated fracture that would affect device use or walking
- •Able to stand confidently using a standing device similar to EasyStand
- •Good general health
- •Body dimensions compatible with the device: height 160 to 190 centimeters; femur length 43.5 to 56 centimeters; tibia length 36 to 48.5 centimeters
- •Body weight maximum 100 kilograms
- •Adequate lower limb range of motion: physiological ankle position; hip extension 0 degrees; knee contracture less than 10 degrees
排除标准
- •History of severe neurological disease other than traumatic spinal cord injury (for example multiple sclerosis, cerebral palsy, amyotrophic lateral sclerosis, traumatic brain injury)
- •Serious active illness (for example infection) or reduced exercise tolerance due to cardiovascular or pulmonary disease
- •Abdominal or thoracic condition that prevents exoskeleton use (for example enterostoma, chest deformity) or pressure ulcer that interferes with fitting or use
- •Severe spasticity (Modified Ashworth Scale grade 4)
- •Unstable spine, or limb/pelvic condition limiting load bearing (for example non healed fracture, post amputation state)
- •Heterotopic ossification that impairs joint mobility beyond allowed limits
- •Significant contractures: ankle plantar flexion contracture greater than 0 degrees; knee contracture greater than 10 degrees; hip flexion contracture 20 degrees
- •Psychiatric or cognitive impairment that limits safe device handling or study participation
- •Pregnancy
研究者
Luca Tóth
Head of Biomechanical Laboratory M.D. PhD.
University of Pecs