Non-Ambulatory SCI Walk Using a Robotic Exoskeleton: Effect on Bone and Muscle
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Bilateral Muscle Volume (surrogate for strength)for thigh and shank will be the primary outcome measurement.
研究概览
简要总结
The purpose of this research study is to evaluate an exoskeleton device and mobility skills in the device.
详细描述
Currently, the treatment of muscle and bone deterioration after SCI is very limited; therefore, there is a definite need to further understand the mechanism of breakdown in the musculoskeletal system after a SCI, and, more importantly, find a clinical strategy that will treat muscle and bone loss.
This pilot research grant will collect results that will be used for the design of a multi-site randomized controlled clinical trial to determine whether a Robotic Exoskeleton training [100 sessions; 1hr/session; 4-5 sessions/week] can improve musculoskeletal outcomes more than other current interventions. If the overall objective is to use the progression of technology to enhance functional ambulation for persons with a spinal cord injury, then the investigators need to evaluate the health benefits associated with continual use of the device.
The study will be a prospective, single-group, repeated measure design using a 2 -month lead in to establish stability, 5-month intervention phase and 2 -month follow-up phase for retention will be performed. Each participant will be used as his or her own control. This project will be completed at two sites: Kessler Foundation will be the lead site that will be under the direction of Dr. Gail F Forrest (Principal Investigator) and Spinal Cord Damage Research Center, James J Peters VA Medical Center under the direction of Dr. Ann M. Spungen (collaborator). Both sites have exoskeletal-assisted walking programs.
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
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be a non walker with a SCI greater than 1 year post injury
- •Must have a neurological level between the C6-T10 level
- •Must have a lower extremity score greater than 1 as defined by the neurological exam
- •Must be between 21 and 45 years old
- •Must be wheelchair reliant 100% of time
- •Must have knee bone mineral density greater than .5755 gm/cm2 as determined by study staff
- •Must have a score on the Modified Ashworth Scale equal to or less than 3 as determined by the study staff
- •Must be able to tolerate upright standing for up to 30 minutes
- •Must have joint range of motion within normal functional limits for ambulation
- •Must have sufficient upper body strength to balance using the walker while wearing the exoskeleton
- •Must have a height between 62 inches or 74 inches
- •Must weigh less than 220 lbs,(limitation of the devices)
- •Must have no joint tightening of any extremity that limits movement during walking with the assistive devices
- •Must have no medical issue that precludes full weight bearing, ambulation or exercise intolerance in the exoskeleton (e.g. orthopedic injuries, pain, severe spasticity)
- •Must have no skin issues (e.g. pressure sores) that would prevent wearing the device
- •Must have no memory and/or thinking disability (e.g. due to brain injury)
- •Must be able to follow directions well and demonstrate learning capability
- •Must be able to physically fit into the exoskeletal device
排除标准
- •A woman who is pregnant, lactating, or post-menopausal
- •Wearing an external device that supports the spinal column or the head, neck, or trunk
- •Have persistent orthostatic hypotension (blood pressure drop of more than 30 millimeters of Mercury in robotic system)
- •Have had a hospitalization for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study or no presence of major cardiovascular or pulmonary disease, lower extremity deep vein thrombosis (within the last three months)
- •Have been taking any medications known to influence bone metabolism
结局指标
主要结局
Bilateral Muscle Volume (surrogate for strength)for thigh and shank will be the primary outcome measurement.
时间窗: 100 hours
To examine the effectiveness of exoskeleton assisted overground walking (5 hours per week, 100 sessions, 20 weeks = 100 hours) to induce positive changes in muscle volume and structure of the lower limbs for non-ambulatory persons with SCI.
次要结局
- Muscle Activation(100 hours)
研究者
Gail Forrest
Principal Investigator
Kessler Foundation