Safety of Exoskeleton-assisted Walking in SCI Inpatient Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of fall
研究概览
简要总结
To assess how safe the exoskeleton, EksoGT, is to use for acute inpatient rehabilitation, if it helps people to walk better than with traditional walking training methods, or if they have any other effects (better or worse) on recovery.
详细描述
Wearable robots that assist with walking over ground are now available in rehabilitation centers. However, the study team did not know how soon it is safe to start using these devices for rehabilitation, if they helped people to walk better than with traditional locomotor training methods, or if they had any other effects (better or worse) on recovery.
The study team's objectives of this study were to explore the safety, feasibility, and efficacy of using the powered exoskeleton, EksoGT, to provide a locomotor training intervention in acute inpatient rehabilitation for persons with spinal cord injury (SCI) who were eligible for locomotor training.
Aim 1 examined the safety of exoskeleton use for persons with SCI during inpatient rehabilitation. Measures for this aim analyzed the amount of falls as well as types and counts of other adverse events (AE) for both serious and non-serious events as outlined by the FDA.
Aim 2 helped determine the feasibility of exoskeleton use during inpatient rehabilitation for SCI by monitoring the time from admission to first stand in the device, accumulated step count/time in the device, and progression of locomotor training frequency, duration, and intensity.
Aim 3 explored the potential for associations between exoskeleton use in inpatient rehabilitation and body functions and activities associated with walking. Measures for this aim included: American Spinal Injury Association (ASIA) Impairment Scale (AIS), Neurological Level of Injury (NLI), Upper and Lower Extremity Motor Scores, and Functional Index Measure (FIM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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 greater
- •Height between 5'2" and 6'2" (1.6 meters to 1.9 meters)
- •Weight less than 220 pounds (100 kilograms)
- •Near Normal range of motion (ROM), as follows:
- •Hip: 5 degrees of extension; 110 of flexion
- •Knee: Full extension to 110 of flexion
- •Ankle: at least 0 of dorsiflexion to 25 of plantarflexion
- •Are eligible for locomotor training as part of inpatient rehabilitation
- •Independent with static sitting balance
- •Sufficient function upper extremity strength to manage walking aid (front-wheeled walker, platform walker, or crutches)
- •Able to follow directions
排除标准
- •Uncontrolled cardiovascular conditions (i.e. heart failure, angina, hypertension)
- •Inability to stand upright due to orthostatic hypotension
- •Body characteristics that do not fit within exoskeleton limits
- •Upper leg length discrepancy > 0.5" or lower leg discrepancy >0.75"
- •Skin integrity issues in areas that would contact the device or that would likely be made worse by device use
- •Pregnancy
- •Colostomy
- •Non-English Speaking
- •The participant is able to walk better with exoskeleton assistance at baseline
- •Any other issue that might prevent safe standing or walking
研究组 & 干预措施
Exoskeletal-assisted walking training group
Prospective subjects were recruited following admission to the SCI inpatient unit at Mount Sinai Hospital. Attending physicians and rehabilitation clinicians identified patients admitted to the unit who may be eligible for the study.
干预措施: EksoGT (Device)
Matched control group
Twenty inpatients with SCI were identified as the matched control group through reviewing an acute inpatient rehabilitation database of Uniform Data System for Medical Rehabilitation by a person blinded to the study.
The control group received a minimum of 15 hours of standard of care, including physical and occupational therapy, for acute inpatient rehabilitation per week. The control groups received the same amount of acute rehabilitation time per week as the intervention group.
结局指标
主要结局
Number of fall
时间窗: 2 years
Number of falls to assess safety
Number of adverse events
时间窗: 2 years
types and counts of the adverse events for both serious and non-serious events as outlined by the FDA to assess safety
次要结局
- Lower Extremity Motor Scores (LEMS)(2 years)
- The time from admission to first stand in the device(2 years)
- Proportion of walking time(2 years)
- Neurological Level of Injury (NLI)(2 years)
- Functional Independence Measure (FIM)(2 years)
- Accumulated step count in the device(2 years)
- Accumulated step time in the device(2 years)
- American Spinal Injury Association (ASIA) Impairment Scale (AIS)(2 years)
- Upper Extremity Motor Scores (UEMS)(2 years)
研究者
Miguel Escalon
Assistant Professor
Icahn School of Medicine at Mount Sinai