Impact of Gait Training With an Exoskeleton on Walking Function After Spinal Cord Injury (SCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Functional ambulation category (FAC) to measure gait quality
研究概览
简要总结
The purpose of this study is to assess the use of Indego as a gait training tool for subjects with complete or incomplete paraplegia as a result of spinal cord injury (SCI) who have preserved lower extremity function. It is hypothesized that subjects with complete or incomplete paraplegia who have preserved their lower extremity function will experience functional improvements after gait training with the Indego exoskeleton.
Subjects will complete a total of fifteen (15) sessions which include a combination of the following; Physical Therapy Evaluation, Indego Training, Mid-Way Assessment, and Post-Assessment.
The aim of this study is to measure the impact of gait training with the Indego device on body structure, function, and participation. Additionally it will assess the perceptions of physical therapists and subjects with SCI on the effectiveness of gait training with the Indego exoskeleton in subjects with preserved limited function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •18 years or older
- •Height 5'1" to 6'3" (Acceptable height may vary by a few inches depending on femur length)
- •Weight 250 lbs or less
- •Present with paraplegia resulting from a complete or incomplete (AIS A, B, C, or D) Spinal Cord Injury (>1 year post-injury), with preserved LE function
- •Uses wheelchair as primary means of mobility in the community
- •Able to ambulate 14 meters with assist of 2 people and no orthostasis. Subjects may use any combination of stability aids and/or bracing.
- •Medical clearance for weight bearing and locomotor training
- •Bone density exams will be at the discretion of each sites' Principle Investigator
- •Passive range of motion (PROM) at shoulders, trunk, hips, knees and ankles within functional limits for safe gait and use of appropriate assistive device/stability aid
- •Skin intact where interfaces with the Indego device
- •Modified Ashworth Scale 3 or less in bilateral LEs
- •Blood pressure and heart rate within Locomotor Training Guidelines
- •At rest: Systolic 150 or less Diastolic 90 or less and Heart rate 105 or less
- •Exercise: Systolic 180 or less Diastolic 105 or less and Heart Rate 145 or less
排除标准
- •Inability to meet ALL inclusion criteria
- •Currently participating in physical therapy for gait training
- •Joint contractures of the shoulders, trunk, hips knees or ankles deemed unsafe for locomotor training by PT and or MD
- •Edema that would put skin at risk for breakdown
- •Modified Ashworth Spasticity of 4
- •Inability to achieve adequate fit of the Indego device
- •Pregnancy
- •Colostomy bag
研究组 & 干预措施
SCI Patients
- 10 subjects with complete or incomplete SCI (> 1 year post-injury) with preserved LE function will be recruited.
- No control group
干预措施: Indego Powered Exoskeleton (Device)
结局指标
主要结局
Functional ambulation category (FAC) to measure gait quality
时间窗: 1 Day
Categorizes patients according to basic motor skills necessary for functional ambulation
10 Meter Walking Test to measure fast gait speed
时间窗: 1 Day
Assesses walking speed in meters per second over a short duration
6 Minute Walking test to measure endurance
时间窗: 6 Minutes
Measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
次要结局
未报告次要终点