Orthostatic Tolerance During FES-evoked Stepping in Paraplegia: A Safety and Viability Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change of systolic blood pressure during three FES-evoked stepping conditions
研究概览
简要总结
Objective:
The objective of this research is to undertake a safety and viability study of FES-evoked stepping in individuals with paraplegia. The rationale for this objective is based upon the need to clarify whether physiological limitations, especially orthostatic intolerance, limit functional mobility outcomes. The cardiovascular, autonomic, and muscle metabolic factors governing orthostatic tolerance during skin-surface FES stepping will be investigated, since this functional task forms the basis of upright mobility and engenders strong physiological challenges upon key regulatory processes in the SCI (spinal cord injury) patient.
Specific Hypotheses:
i. Reduction of blood pressure will be greater during FES-evoked stepping than during passive stepping; ii. Reduction of blood pressure will be greater during FES-evoked stepping with no upper body component versus FES-stepping with an upper body component; iii. Blood pressure will be reduced even further during FES-evoked stepping following a 6-week progressive-intensity gait training intervention.
详细描述
Aims:
The primary aim of the safety and viability study is to assess changes in blood pressure during up to 60-min of FES-evoked stepping versus up to 60-min of stepping.
A secondary aim is to investigate changes in blood pressure during FES-assisted stepping with and without a voluntary upper-limb component of gait.
Specific Hypotheses:
i. Reduction of blood pressure will be greater during FES-evoked stepping than during passive stepping; ii. Reduction of blood pressure will be greater during FES-evoked stepping with no upper body component versus FES-stepping with an upper body component; iii. Blood pressure will be reduced even further during FES-evoked stepping following a 6-week progressive-intensity gait training intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •A spinal cord lesion, of traumatic etiology, between the 6th and 11th thoracic spinal segments
- •Sensory and motor complete lesion (ASIA [American Spinal Injury Association]-A)
- •At least 2 years post injury
- •Between 18-55 years of age
- •Responsive to electrical stimulation
排除标准
- •Severe osteoporosis, fractures, dislocations (as determined by X-ray and DEXA)
- •Upper limb or shoulder pathologies
- •Severe spasticity (≥4 on Ashworth scale)
- •Contractures
- •Currently undertaking FES or gait training
结局指标
主要结局
Change of systolic blood pressure during three FES-evoked stepping conditions
次要结局
- Cardiovascular and Metabolic Responses
- Humoral Responses
- Syncope Symptom Score
- Muscle Metabolic Responses
- Autonomic Responses