Effects of Activity Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bladder Storage
研究概览
简要总结
Bladder and sexual dysfunction consistently ranks as one of the top disorders affecting quality of life after spinal cord injury. The insights of how activity-based training affects bladder function may prove to be useful to other patient populations with bladder and sexual dysfunction such as multiple sclerosis, Parkinson's, and stroke, as well as stimulate investigations of training's effects within other systems such as bowel dysfunction. Locomotor training could help promote functional recovery and any insights gained from these studies will enhance further investigation of the effect of bladder functioning after spinal cord injury. In addition, as suggested by a study of one of our initial participants, a reduction in the use and/or dosage of medication to enhance sexual function is a possible outcome, medications which carry risks and side effects.
详细描述
Objectives: To determine the effects of weight-bearing task-specific training for locomotion (stepping on a treadmill) after traumatic incomplete and complete spinal cord injury in humans on a) urodynamic parameters and b) sexual function outcomes. Weight-bearing (stand-only) and non-weight-bearing exercise (i.e. arm crank) will serve as controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Criteria: Inclusion Criteria:
- •stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training
- •no painful musculoskeletal dysfunction,
- •unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with training
- •no clinically significant depression or ongoing drug abuse;
- •clear indications that the period of spinal shock is concluded determined by presence of muscle tone, deep tendon reflexes or muscle spasms and discharged from standard inpatient rehabilitation
- •non- progressive suprasacral spinal cord injury
- •bladder and sexual dysfunction as a result of spinal cord injury
排除标准
- •unstable medical condition with cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training;
- •painful musculoskeletal dysfunction, unhealed fractures, contractures, pressure sores or urinary tract infections that might interfere with training
- •clinically significant depression or ongoing drug abuse;
- •clear indications that the period of spinal shock has not concluded and not discharged from standard inpatient rehabilitation
- •progressive spinal cord injury
- •no bladder and sexual dysfunction as a result of spinal cord injury
研究组 & 干预措施
Activity-based locomotor training
To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions.
干预措施: Activity-based locomotor training (Procedure)
Activity-based stand training
To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions.
干预措施: Activity-based stand training (Procedure)
Activity-based upper arm ergometry
To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions.
干预措施: Activity-based upper arm ergometry (Procedure)
Activity based training + spinal epidural stimulation
combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
干预措施: Activity-based locomotor training (Procedure)
Activity based training + spinal epidural stimulation
combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
干预措施: Activity-based stand training (Procedure)
Activity based training + spinal epidural stimulation
combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.
干预措施: Activity-based training + spinal epidural stimulation (Procedure)
结局指标
主要结局
Bladder Storage
时间窗: 5 years, 2 months
Bladder capacity (mlH2O)
Compliance
时间窗: 5 years, 2 months
Bladder Compliance (ml/cmH2O)
Bladder Emptying
时间窗: 5 years, 2 months
Voiding Efficiency (% voided)
Bladder Pressure
时间窗: 5 years, 2 months
Leak point pressure (cmH2O)
次要结局
- International Index of Erectile Function (IIEF)(5 years, 2 months)
研究者
Susan Harkema PhD
Professor and Associate Director, Kentucky Spinal Cord Injury Research Center, University of Louisville Owsley B. Frazier Chair in Neurological Rehabilitation Research Director, Frazier Rehab Institute Director of the NeuroRecovery Network
University of Louisville