Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Whole body muscle mass via dual-energy x-ray absorptiometry
研究概览
简要总结
The purpose of this study is to evaluate whether an aerobic and resistance training program or a functional electrical stimulation-assisted Walking program is more effective for reducing health complications related to spinal cord injury, for example, the occurrence of bladder infections, pressure sores and/or frequency of spasms. It is hypothesized that the functional electrical stimulation-assisted walking will have a greater impact on secondary complications than the aerobic and resistance training program.
详细描述
A barrier to maintaining health status and active social participation in the community for individuals with spinal cord injury (SCI) is the broad number of secondary medical complications typically associated with their injury, such as bone loss, spasticity, urinary tract infections and pressure sores. Functional electrical stimulation (FES) is an intervention that applies short current pulses to muscles and causes them to contract. FES can be applied to individuals with SCI to help them restore functions such as walking and grasping by contracting groups of paralyzed muscles in an orchestrated manner. Pilot work conducted by our research group suggests that applying FES to augment functional improvement often reduces incidents of secondary complications such as spasticity, pressure sores, and swelling of the legs. Specifically, functional and meaningful walking tasks performed on a regular basis with the help of FES therapy have the potential to improve overall physical and psychological well being of persons with incomplete SCI. This study seeks to demonstrate that thrice-weekly FES training for 4 months can restore/improve walking function in chronic, incomplete SCI individuals and that this therapy will considerably reduce the occurrences of secondary complications due to SCI. This will subsequently promote opportunities for active social participation and enhance the quality of life for SCI consumers. Comparison: 32 individuals with chronic, incomplete SCI will be randomized to either thrice-weekly FES therapy OR thrice-weekly aerobic and resistance training. The study will determine which therapy is superior for improving walking function and reducing secondary complications associated with SCI after 4 months of training, and after 2-month and 8-month follow-up periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •incomplete spinal cord lesion of sudden onset between C6 and T12 that is motor incomplete (grade C or D on the ASIA neurological impairment scale). The injury must have occurred at least two years prior to recruitment
排除标准
- •contraindications for FES, such as cardiac pacemakers, skin lesions or rush at potential electrode sites, or denervation of targeted muscles.
- •pressure ulcers anywhere on the lower extremities
- •hypertension that is uncontrolled
- •symptoms of orthostatic hypotension when standing for 15 minutes
- •susceptibility to autonomic dysreflexia, requiring medication.
- •if there is a history of cardiovascular disease, participants must obtain medical clearance from their physician before inclusion
研究组 & 干预措施
FES training
Arm 1 receives functional electrical stimulation while walking on body weight suspension training.
干预措施: Compex Motion Stimulator (Device)
Control Group training
Aerobic and resistance training program
干预措施: Conventional Exercise (Other)
结局指标
主要结局
Whole body muscle mass via dual-energy x-ray absorptiometry
时间窗: Baseline, 4 month and 12 months
Bone density at different hip, spine, proximal and distal femur and proximal Tibia using dual-energy xray absorptiometry
时间窗: Baseline, 4 month and 12 months
Bone density, bone geometry and muscle area via computed tomography,
时间窗: Baseline, 4 month and 12 months
Spasticity via Ashworth Scale and Pendulum Test, and
时间窗: Baseline, 4 months, 6 months and 12 months
Factor analysis of electromyography and kinematics of gait.
时间窗: Baseline, 4months and 6 months
次要结局
- Incidence of urinary tract infections,(Over 12 months)
- Spinal cord independence measure,(Baseline and 12 months)
- Urinary N-telopeptide and serum osteocalcin,(Baseline, 4 month, 6 month and 12 months)
- Timed up and go and two-minute walk test (functional mobility),(Baseline, 4 months, 6 months and 12 months)
- Incidence of pressure sores,(Over 12 months)
- Reintegration to normal living index,(Baseline, 4, 6 and 12 months)
- Satisfaction with life scale,(Baseline, 4 , 6 and 12 months)
- Instrumental Activities of Daily Living SubScale,(Baseline, 4, 6 and 12 months)
- Craig Handicap assessment and reporting technique, and(Baseline, 4, 6 and 12 months)
- client perception of treatment (qualitative).(At 12 months)
研究者
Milos Popovic
Senior Scientist
Toronto Rehabilitation Institute